Abiraterone Teva 500mg Film-Coated Tablets
PA1986/103/001
Teva B.V.
| Abiraterone | Similar alternative medicine authorised | API unavailability
(multiple countries affected) | 2024/07/02 | 2025/04/01 | | 2024/07/11 |
Aciclovir 25mg/ml Concentrate for Solution for Infusion
PA0822/215/001
Pfizer Healthcare Ireland
| Aciclovir | Appropriate alternative medicine authorised | Unexpected increase in demand | 2023/12/08 | 2024/10/01 | HCP letter | 2024/03/04 |
Actilyse Cathflo 2mg Powder for Solution for Injection and Infusion
PA0775/011/004
Boehringer Ingelheim International GmbH
| Alteplase
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected)
| 2023/09/13 | 2024/07/22 |
| 2024/03/08 |
Actiq 200 micrograms compressed lozenge with integral oromucosal applicator
PA0749/195/001
Teva Pharma B.V.
| Fentanyl | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/07/20 | 2024/08/15 | | 2024/07/05 |
Alendronic acid/Cholecalciferol Accord 70mg/2800IU Tablets
PA2315/020/001
Accord Healthcare Ireland Ltd.
| Vitamin D3 & alendronic acid
| Similar alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2023/06/07 | Awaiting update from the company
| | 2024/07/11 |
Alendronic acid/Cholecalciferol
Accord 70mg/5600IU Tablets
PA2315/020/002
Accord Healthcare Ireland Ltd.
| Vitamin D3 & alendronic acid
| Similar alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2023/06/07 | Awaiting update from the company
| | 2024/07/11 |
Amoclav 250mg/125mg Film-coated Tablets
PA0711/162/002
Rowex Ltd
| Amoxicillin & clavulanic acid
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected)
| 2023/08/14 | 2024/09/01 | | 2024/06/13
|
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe
PA22580/001/002
Bioprojet Pharma
| Epinephrine
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/06/01 | 2025/04/01 | | 2024/05/24 |
Anidulafungin Teva 100 mg Powder for Concentrate for Solution for Infusion
| Anidulafungin
| Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/07/30 | 2025/10/01 | | 2024/06/04 |
Antabuse 400mg Effervescent Tablets
PA1986/110/001
Teva B.V.
| Disulfiram
| Comparable alternative medicine authorised
| API unavailability
(multiple countries affected) | 2022/07/25 | 2024/09/01 | | 2024/07/16 |
Aprepitant Accord 80 mg hard capsules
PA2315/148/001
Accord Healthcare Ireland Ltd.
| Aprepitant
| Appropriate alternative medicine authorised
| Unexpected increased demand
| 2024/03/11 | Awaiting update from the company | | 2024/03/11 |
Aripiprazole Teva 5mg tablets
PA1986/019/001
Teva B.V.
| Aripiprazole | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/27 | 2024/10/01 | | 2024/06/04 |
Aripiprazole Teva 15mg tablets
PA1986/019/002
Teva B.V.
| Aripiprazole | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/06/13 | 2024/10/01 | | 2024/07/11 |
Artelac 3.2 mg/ml Eye Drops, Solution
PA23259/004/001
Bausch + Lomb Ireland Limited
| Hypromellose
| Appropriate alternative medicine authorised | Awaiting information from the company | 2024/04/30 | Awaiting update from the company | | 2024/05/24 |
Aspirin 75mg Gastro Resistant Tablets
PA0126/246/001
Clonmel Healthcare Ltd
| Aspirin
| Appropriate alternative medicine authorised
| Unexpected increase in demand | 2023/06/12 | 2024/09/30 |
| 2024/04/04 |
Atomoxetine Accord 10mg Hard Capsules
PA2315/019/001
Accord Healthcare Ireland Ltd | Atomoxetine | Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries impacted) | 2024/06/09 | Awaiting update from the company
| HCP letter | 2024/06/05 |
Atomoxetine Accord 18mg Hard Capsules
PA2315/019/002
Accord Healthcare Ireland Ltd | Atomoxetine
| Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries impacted)
| 2024/06/09
| Awaiting update from the company
| HCP letter
| 2024/06/05 |
Atomoxetine Accord 25mg Hard Capsules
PA2315/019/003
Accord Healthcare Ireland Ltd | Atomoxetine
| Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries impacted)
| 2024/06/09
| Awaiting update from the company
| HCP letter
| 2024/06/05 |
Atomoxetine Accord 40mg Hard Capsules
PA2315/019/004
Accord Healthcare Ireland Ltd | Atomoxetine
| Appropriate alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2023/11/06 | Awaiting update from the company | HCP letter
| 2024/06/05 |
Atomoxetine Accord 60mg Hard Capsules
PA2315/019/005
Accord Healthcare Ireland Ltd
| Atomoxetine
| Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries impacted)
| 2023/11/30 | Awaiting update from the company
| HCP letter
| 2024/06/05 |
Atomoxetine Accord 80mg Hard Capsules
PA2315/019/006
Accord Healthcare Ireland Ltd
| Atomoxetine | Appropriate alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2023/10/19 | Awaiting update from the company
| HCP letter
| 2024/06/05 |
Atomoxetine 100mg Hard Capsules
PA2315/019/007
Accord Healthcare Ireland Ltd.
| Atomoxetine | Appropriate alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2024/01/18 | Awaiting update from the company | HCP letter
| 2024/06/05 |
Axsain 0.075% w/w Cream
PA1986/088/001
Teva B.V.
| Capsaicin
| Appropriate alternative medicine authorised | Manufacturing delay | 2023/10/19 | 2025/06/30 | | 2023/10/12 |
Bendamustine 25mg Powder for Concentrate for Solution for Infusion
PA1986/121/001
Teva B.V.
| Bendamustine | Similar alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2023/10/25 | 2025/01/31 | | 2023/10/27 |
Betnovate Cream 0.1% w/w
(30g presentation)
PA1077/001/001
GlaxoSmithKline (Ireland) Limited
| Betamethasone
| Appropriate alternative medicine authorised | Manufacturing delay
(multiple markets impacted) | 2024/06/14 | 2024/08/26 | | 2024/06/13 |
Bisodol Antacid Chewable Tablets
PA1986/071/001
Teva B.V.
| Calcium carbonate, Sodium hydrogen carbonate, Light magnesium carbonate
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/06/20 | Awaiting update from the company |
| 2024/06/14 |
Brinzolamide 10mg/ml Eye Drops, Suspension
PA2315/149/001
Accord Healthcare Ireland Ltd.
| Brinzolamide | Similar alternative medicine authorised | Manufacturing delay | 2024/02/23 | Awaiting update from the company | | 2024/05/14 |
Calcium Resonium 99.934 % Powder for oral or rectal suspension
PA0540/141/001
Sanofi-Aventis Ireland Limited T/A SANOFI
| Calcium polystyrene sulphonate
| No alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/07/10 | 2024/09/02 | | 2024/07/05 |
Candesartan Krka 4mg tablets
PA1347/026/001
KRKA, d.d., Novo mesto
| Candesartan
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/04/30 | 2024/09/15 | | 2024/06/27 |
Candesartan 4 mg Tablets
PA2315/150/001
Accord Healthcare Ireland Ltd.
| Candesartan
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/06/28 | Awaiting update from the company
| | 2024/06/28 |
Cefotaxime 1g Powder for Solution for Injection or Infusion
PA0281/223/002
Pinewood laboratories Ltd
| Cefotaxime
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/05/15 | Awaiting update from the company | | 2024/05/15 |
Cefuroxime 1.5g powder for solution for injection/infusion
PA2059/006/002
Fresenius Kabi Deutschland GmbH
| Cefuroxime
| Similar alternative medicine authorised
| Manufacturing delay
| 2024/06/21
| Awaiting update from the company
| | 2024/06/24
|
Centrax 10mg Tablets
PA0822/010/001
Pfizer Healthcare Ireland
| Prazepam
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2022/06/30 | Unknown at present | | 2023/10/24 |
Champix 0.5 mg + 1 mg Film Coated Tablet
EU/1/06/360/003
Pfizer Europe MA EEIG
| Varenicline
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2021/06/21 | 2024/06/15 | HCP letter
| 2023/05/26 |
Champix 0.5mg Film Coated Tablet
EU/1/06/360/001
Pfizer Europe MA EEIG
| Varenicline
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2021/06/21 | 2024/06/15 | HCP letter
| 2023/05/26 |
Champix 1mg Film Coated Tablet
EU/1/06/360/005
Pfizer Europe MA EEIG
| Varenicline
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2021/06/21 | 2024/06/15 | HCP letter
| 2023/05/26 |
Clarithromycin 250mg Film-Coated Tablets
PA2315/136/003
Accord Healthcare Ireland Ltd.
| Clarithromycin
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2023/04/12 | Awaiting update from the company
| | 2024/03/31 |
Clarithromycin 500mg Film-coated tablets
PA2315/197/002
Accord Healthcare Ireland Ltd.
| Clarithromycin
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2023/07/24 | Awaiting update from the company
| | 2024/03/21 |
Clonfolic 0.4mg Tablets
PA0126/095/001
Clonmel Healthcare Ltd
28 pack size | Folic acid | Similar alternative medicine authorised | Quality issue
| 2024/07/22 | 2024/12/15 | | 2024/07/05 |
Clonfolic 0.4mg Tablets
PA0126/095/001
Clonmel Healthcare Ltd
98 pack size | Folic acid | Similar alternative medicine authorised | Quality issue | 2024/06/25 | 2024/12/15 | | 2024/07/05 |
Cilique 250/35 micrograms tablets
PA1330/029/001
Gedeon Richter Plc
| Norgestimate
& ethinylestradiol | Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected)
| 2024/01/01 | Awaiting update from the company
| | 2024/02/27 |
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
50mg/ml presentation
PA0822/199/001 Pfizer Healthcare Ireland | Cisplatin | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/06/10 | 2024/09/31 | HCP letter | 2024/05/29 |
Clarithromycin Teva 250 mg film-coated tablets
PA0749/148/001
Teva B.V. | Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2024/05/10 | 2024/10/13 | | 2024/07/24 |
Clarithromycin Teva 500 mg film-coated tablets
PA0749/148/002
Teva B.V.
| Clarithromycin
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries impacted)
| 2024/06/10 | 2025/02/01 | | 2024/07/24 |
Clindamycin 150 mg/ml solution for injection
(600mg/4ml presentation)
PA2059/007/001
Fresenius Kabi Deutschland GmbH
| Clindamycin
| Similar alternative medicine authorised | Quality issue | 2024/07/01 | 2024/07/22 | | 2024/07/12 |
Clonocid 250mg Film Coated Tablets
PA0126/136/001
Clonmel Healthcare Ltd
| Clarithromycin
| Similar alternative medicine authorised | Unexpected increase in demand | 2024/02/22 | 2024/06/30 | | 2024/03/14 |
Clorom 250mg Tablets
PA0711/061/001
Rowex Ltd
| Clarithromycin
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/05/09 | 2024/06/30 |
| 2024/01/16 |
Clorom 500mg Tablets
PA0711/061/002
Rowex Ltd
| Clarithromycin | Similar alternative medicine authorised | Manufacturing delay | 2023/09/23 | 2024/06/30 | | 2024/01/16 |
Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for Injection/Infusion
PA0749/011/001
Teva Pharma B.V.
|
Amoxicillin & clavulanic acid
| Similar alternative medicine authorised
| Unexpected increase in demand | 2024/03/15 | 2025/02/01 | | 2024/07/24 |
Cocois Ointment, coal tar 12.0% sulphur for external use 4.0%, salicylic acid 2.0
40g and 100g presentations
PA1638/005/001
RPH Pharmaceuticals AB
| Various | Similar alternative medicine authorised | Regulatory issue
(multiple countries impacted) | 2024/06/30 | 2025/03/01 | | 2024/06/18 |
Cosartal Plus 50mg/12.5mg Film Coated Tablets
PA2315/190/001
Accord Healthcare Ireland Ltd.
| Losartan & hydrochlorothiazide
| Similar alternative medicine authorised
| Quality issue
(multiple countries affected) | 2022/02/01
| Awaiting update from the company
|
| 2024/07/11 |
Co-Vatan 160 mg/25 mg Film-coated Tablets
PA0711/182/003
Rowex Ltd
| Valsartan & hydrochlorothiazide
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/12/18 | Awaiting update | | 2024/06/13 |
Creon 10000 Gastro-resistant Capsules
PA23355/006/001
Viatris Healthcare Limited
| Lipase & Amylase & Protease
| No alternative medicine authorised | Unexpected increase in demand
| 2024/07/24 | 2024/08/13 | HCP letter
| 2024/07/24 |
Creon 25000 Gastro-resistant Capsules
PA23355/006/002
Viatris Healthcare Limited
| Lipase & Amylase & Protease
| No alternative medicine authorised
| Unexpected increase in demand
| 2024/07/24
| 2024/08/13
| HCP letter
| 2024/07/24 |
Cymevene 500 mg powder for concentrate for solution for infusion
PA2239/003/001
CHEPLAPHARM Arzneimittel GmbH | Ganciclovir | Comparable alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2024/04/29 | 2024/08/14 | | 2024/06/21 |
Daktarin 20mg/g Oral Gel
PA0330/048/003
Johnson & Johnson (Ireland) Limited
| Miconazole
| Appropriate
alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2023/08/3 | 2025/01/01 | | 2024/03/12 |
Deslor 0.5 mg/ml Oral Solution
PA0711/202/002
Rowex Ltd
| Desloratidine
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2024/01/22 | 2024/08/31 | | 2024/06/14 |
Desmospray Desmopressin Nasal Spray
PA1009/005/001
Ferring Ireland Ltd
| Desmopressin
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected) | 2020/07/22 | Awaiting update from the company
|
| 2024/01/17 |
Dexamethasone Phosphate 4 mg/ml Solution for Injection
PA0822/201/001
Pfizer Healthcare Ireland
| Dexamethasone
| Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/07/22 | 2024/08/19 | HCP letter | 2024/07/12 |
Dexmedetomidine Accord 100mcg Concentrate for solution for infusion
EU/1/19/1418/010
Accord Healthcare S.L.U.
| Dexmedetomidine
| Similar alternative medicine authorised
| Manufacturing delay | 2024/02/29 | Awaiting update from the company | | 2024/02/29 |
Diazemuls 5mg/ml Emulsion for Injection
PA2315/098/001
Accord Healthcare Ireland Ltd.
| Diazepam
| Appropriate alternative medicine authorised
| Manufacturing delays | 2020/02/15 | Unknown at present |
| 2023/07/2023 |
Diclac 75mg Prolonged Release Tablets
PA0711/009/003
Rowex ltd
| Diclofenac | Similar alternative medicine authorised | Manufacturing delay | 2024/04/01 | 2024/06/31 | | 2024/04/03 |
Dipentum 250mg Capsules
PA22657/001/001
Atnahs Pharma Netherlands B.V.
| Olsalazine
| Appropriate alternative medicine authorised
| Manufacturing delays
(multiple countries affected) | 2022/09/01 | Awaiting update from the company |
| 2024/04/05 |
Dipentum 500mg Tablets
PA22657/001/002
Atnahs Pharma Netherlands B.V.
| Olsalazine
| Appropriate alternative medicine authorised
| Manufacturing delays
(multiple countries affected) | 2022/09/01 | Awaiting update from the company |
| 2024/06/13 |
Donepezil 5mg Film-coated Tablets
PA2315/033/001
Accord Healthcare Ireland Ltd.
| Donepezil
| Similar alternative medicine authorised
| Manufacturing delay | 2023/07/01 | Awaiting update from the company | | 2024/07/11 |
Donepezil Hydrochloride Bluefish 10mg Film-coated Tablet
PA1436/015/002
Bluefish Pharmaceuticals AB
| Donepezil
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2023/09/15 | Awaiting update from the company | | 2024/04/22 |
Donepezil Krka 10 mg film-coated tablets
PA1347/014/004
KRKA, d.d., Novo mesto
| Donepezil
| Similar alternative medicine authorised
| Awaiting information | 2024/02/02 | 2024/05/06 | | 2024/02/06 |
Donepezil Hydrochloride Bluefish 5mg Film-coated Tablet
PA1436/015/001
Bluefish Pharmaceuticals AB
|
Donepezil
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/07/31 | 2024/04/30 |
| 2023/12/18 |
Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules
PA0074/076/001
Rowa Pharmaceuticals Limited
| Dutasteride & Tamsulosin | Exact alternative medicine authorised
| Manufacturing delays | 2024/07/24 | 2024/08/01 | | 2024/07/25 |
Doxane XL 4 mg prolonged-release tablets
PA0711/103/001
Rowex Ltd
| Doxazosin
| Appropriate alternative medicine authorised
| Unexpected increase in demand
| 2023/11/27 | 2024/12/30 | | 2024/02/02 |
Dukoral
EU/1/03/263/002
Crucell Sweden AB
| Cholera vaccine
| Comparable alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected) | 2022/09/01 | 2024/10/31 |
| 2024/03/22 |
| Duloxetine Accord 60mg hard gastro-resistant capsules PA2315/268/002 Accord Healthcare Ireland Ltd. | Duloxetine
| Similar alternative medicine authorised | Quality issue | 2024/03/31 | Awaiting update from the company | | 2024/03/20 |
Duloxetine Clonmel 30mg Gastro Resistant Hard Capsules
PA0126/269/002
Clonmel Healthcare Ltd
| Duloxetine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/14 | 2024/06/23 | | 2024/06/14 |
Duloxetine Clonmel 60mg Gastro Resistant Hard Capsules
PA0126/269/004
Clonmel Healthcare Ltd
| Duloxetine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/06/17 | 2024/07/15 | | 2024/06/14 |
Dutasteride/Tamsulosin hydrochloride 0.5 mg /0.4 mg Capsules
PA0577/230/001
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Tamsulosin & dutasteride
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/09/22 | Awaiting update from the company |
| 2024/04/22 |
Effentora 600 microgram Buccal Tablet
EU/1/08/441/008
Teva B.V.
| Fentanyl | Similar alternative medicine authorised | Regulatory issue
| 2024/01/05 | 2024/09/05 | | 2024/06/01 |
ENAP 5mg Tablets
PA0711/028/001
Rowex Ltd
| Enalapril
| Similar alternative medicine authorised
| Awaiting information
| 2024/06/10 | 2024/10/01 | | 2024/06/14 |
ENAP 10mg Tablets
PA0711/028/002
Rowex Ltd
| Enalapril
| Similar alternative medicine authorised
| Manufacturing delay
| 2024/01/29 | 2024/08/15 | | 2024/07/11 |
Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion
PA2315/034/001
Accord Healthcare Ireland Ltd | Epirubicin | Appropriate alternative medicine authorised | API unavailability
| 2024/01/31 | Awaiting update from the company | | 2024/03/08 |
Eplerenone 25mg Film Coated Tablets
PA2315/085/001
Accord Healthcare Ireland Ltd.
| Eplerenone | Similar alternative medicine authorised | Manufacturing delay | 2024/02/24 | Awaiting information from the company | | 2024/02/09 |
Eplerenone Mylan 25 mg film-coated tablets
PA0577/168/001
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Eplerenone
| Similar
alternative medicine authorised
| API unavailability
(multiple countries affected) | 2023/10/09 | 2024/10/01 | | 2024/06/13 |
Erythrocin 500 mg Tablets
PA1142/008/003
Amdipharm Limited
| Erythromycin
| Similar alternative medicine authorised | Manufacturing delay | 2024/05/06 | 2024/10/15 | | 2024/07/12 |
Esomeprazole 40mg Gastro Resistant Tablets
PA2315/127/004
Accord Healthcare Ireland Ltd.
| Esomeprazole
| Similar alternative medicine authorised
| Manufacturing delay | 2023/07/15 | 2024/11/01 |
| 2024/07/11 |
Estradot 37.5 micrograms/24 hours, transdermal patch
PA23311/004/001
Sandoz Pharmaceuticals d.d.
| Estradiol
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2024/07/17 | Awaiting update from the company |
| 2024/07/18 |
Estradot 50 micrograms/24 hours, transdermal patch
PA23311/004/002
Sandoz Pharmaceuticals d.d.
| Estradiol
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/07/10 | Awaiting update from the company
| | 2024/07/18 |
Estradot 75 micrograms/24 hours, transdermal patch
PA23311/004/003
Sandoz Pharmaceuticals d.d
| Estradiol
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/06/26 | Awaiting update from the company
| | 2024/07/18 |
Estradot 100 micrograms/24 hours, transdermal patch
PA23311/004/004
Sandoz Pharmaceuticals d.d.
| Estradiol | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/07/30 | Awaiting update from the company | | 2024/07/18 |
Ezetimibe 10mg Tablets
PA0577/198/001
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Ezetimibe | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/16 | Awaiting update from the company | | 2024/06/13 |
Ezetimibe 10mg Tablets
PA2315/088/001 Accord Healthcare Ireland Ltd. | Ezetimibe | Similar alternative medicine authorised | Unexpected increase in demand | 2024/05/31 | Awaiting update from the company | | 2024/05/17 |
Ezetimibe/Simvastatin Teva Pharma 10 mg/20 mg tablets
PA1986/067/001
Teva BV | Ezetimibe & Simvastatin
| Exact alternative medicine authorised | Unexpected increase in demand
| 2024/08/07 | 2024/09/16 | | 2024/07/24 |
Faverin 50 mg film-coated tablets
Viatris Healthcare Limited | Fluvoxamine maleate
| Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/07/01 | 2024/08/05 | | 2024/07/18 |
Fasturtec 7.5 mg/5ml powder and solvent for concentrate for solution for injection
EU/1/00/170/002
Sanofi Winthrop Industrie
| Rasburicase
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/06/18 | 2024/07/31 | HCP letter
| 2023/06/07 |
Fintrid 5mg Film Coated Tablets
Aurobindo pharma (malta) limited
| Finasteride | Similar alternative medicine authorised | Manufacturing delay | 2024/06/10 | 2024//08/01 | | 2024/07/11 |
Flector Tissugel 140mg Medicated Plaster
PA1104/004/001
IBSA Farmaceutici Italia S.r.l
| Diclofenac
| Appropriate alternative medicine authorised
| Distribution issue | 2023/10/31 | Unknown at present |
| 2023/11/08 |
Flucloxacillin 1g Powder for Solution for Injection or Infusion
PA0281/122/003
Pinewood Laboratories Ltd
| Flucloxacillin
| Similar alternative medicine authorised
| Manufacturing delays | 2023/07/11 | Awaiting update from the company | | 2023/11/21 |
Fluconazole 50mg hard capsule
PA2315/090/001
Accord Healthcare Ireland Ltd
| Fluconazole | Similar alternative medicine authorised | Manufacturing delay | 2023/12/25 | 2024/08/01 | | 2024/05/16 |
Fluconazole 150 mg hard capsule
PA2315/090/002
Accord Healthcare Ireland Ltd.
| Fluconazole
| Similar alternative medicine authorised
| API unavailability | 2023/08/01 | 2024/08/01 |
| 2024/05/16 |
Fluconazole 200 mg hard capsule
PA2315/090/003
Accord Healthcare Ireland Ltd.
| Fluconazole
| Similar alternative medicine authorised
| API unavailability | 2023/08/01 | 2024/08/01 |
| 2024/05/16 |
Fludarabine Phosphate 25mg/ml Concentrate for Solution for Injection or Infusion
PA2315/035/001
Accord Healthcare Ireland Ltd.
| Fludarabine
| Comparable alternative medicine authorised | API unavailability | 2024/02/15 | 2024/08/31 | | 2024/02/19 |
Fluorouracil 25mg/ml Solution for Injection or Infusion
100ml presentation
PA0822/223/001
Pfizer Healthcare Ireland
| Fluorouracil
| Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected) | 2022/02/25 | Awaiting update from the company | HCP letter
| 2024/01/03 |
Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion
350mg/35ml presentation
PA2059/001/001
Fresenius Kabi Deutschland GmbH
| Folinic acid
| Similar alternative medicine authorised | API unavailability | 2024/05/02 | 2024/06/17 | | 2024/06/04 |
Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion
500mg/50ml presentation
PA2059/001/001
Fresenius Kabi Deutschland GmbH
| Folinic acid
| Similar alternative medicine authorised | API unavailability | 2024/05/03 | 2024/07/22 | | 2024/05/07 |
Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion
100mg/10ml presentation
PA2059/001/001
Fresenius Kabi Deutschland GmbH
| Folinic acid
| Similar alternative medicine authorised | API unavailability | 2024/05/30 | 2024/10/01 | | 2024/06/04 |
Fostepor Once Weekly 70mg tablets
PA0577/086/002
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Alendronic acid
| Similar alternative medicine authorised
| Regulatory issue
(multiple countries affected) | 2024/02/26 | 2024/06/30 | | 2024/02/12 |
Fucithalmic 10mg/g Viscous Eye Drops, suspension
PA1142/016/001
Amdipharm Limited
| Fusidic acid | Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2023/11/06 | 2024/11/30 | | 2023/12/12 |
Furosemide 20mg in 2ml Solution for Injection
PA0073/059/004
Mercury Pharmaceuticals (Ireland) Ltd
| Furosemide | Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/05/30 | 2024/07/15 | | 2024/06/18 |
Fybogel Citrus 3.5g Granules
PA0979/009/001
Reckitt Benckiser Ireland Ltd
| Ispaghula husks
| Appropriate alternative medicine authorised
| Manufacturing delays | 2023/05/15 | Awaiting update from the company
|
| 2024/02/02 |
Fybogel Mebeverine Granules for Oral Suspension
PA0979/010/001
Reckitt Benckiser Ireland Ltd
| Ispaghula husks
| Appropriate alternative medicine authorised | Awaiting information from the company | 2023/12/04 | Awaiting update from the company
| | 2024/03/11 |
Gamanil 70mg Film Coated Tablets
PA1701/004/001
Zentiva k.s.
| Lofepramine
| Comparable alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2023/12/31 | Awaiting update from the company | Gamanil shortage letter | 2024/07/17 |
Geltears 0.2 % w/w carbomer eye gel
PA23259/006/001
Bausch + Lomb Ireland Limited
| Carbomer | Similar alternative medicine authorised | Manufacturing delay | 2024/04/26 | Awaiting update from the company | | 2024/05/27 |
Gemcitabine Teva 40mg/ml Concentrate for Solution for Infusion
(5ml presentation)
PA1986/122/001
Teva B.V.
| Gemcitabine
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/09/01 | Awaiting update from the company |
| 2024/07/16 |
Gemcitabine Teva 40mg/ml Concentrate for Solution for Infusion
(25ml presentation)
PA1986/122/001
Teva B.V.
| Gemcitabine | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2023/08/15 | Awaiting update from the company
| | 2024/07/16 |
Gemcitabine Teva 40mg/ml Concentrate for Solution for Infusion
(50ml presentation)
PA1986/122/001
Teva B.V.
| Gemcitabine
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/06/05 | Awaiting update from the company
|
| 2024/07/16
|
Gentamicin 10mg/ml Solution for Injection or Infusion
PA0281/242/001
Pinewood Laboratories Ltd
| Gentamicin
| Appropriate alternative medicine authorised
| Manufacturing delay
| 2023/08/01 | Unknown at present | | 2023/11/23 |
Gentamicin 40mg/ml Solution for Injection or Infusion
PA0281/242/002
Pinewood Laboratories Ltd
| Gentamicin | Appropriate alternative medicine authorised | Manufacturing delay | 2023/08/01 | Unknown at present | | 2023/11/23 |
Genotropin 5.3 mg powder and solvent for solution for injection, with preservative
PA0822/128/001
Pfizer Healthcare Ireland
| Somatropin | Similar alternative medicine authorised | Unexpected increase in demand
(multiple countries affected) | 2024/07/15 | 2024/09/02 | | 2024/07/10 |
Germentin 250mg/125mg Film Coated Tablets
PA0577/034/003
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Amoxicillin & clavulanic acid
| Similar alternative medicine authorised | Unexpected increase in demand
(multiple countries affected) | 2023/11/06 | 2024/07/28 | | 2024/02/15 |
Golden Eye 0.1% w/v Eye Drops
PA22695/001/001
Cambridge Healthcare Ireland Limited
| Propamidine
| Appropriate alternative medicine authorised
| Regulatory issue
(multiple countries affected) | 2022/11/16 | 2024/09/01 |
| 2024/02/14 |
Golden Eye 0.15% w/w Eye Ointment
PA22695/001/002
Cambridge Healthcare Ireland Limited
| Dibromopropamidine
| Appropriate alternative medicine authorised
| Manufacturing delays
(multiple countries affected) | 2022/11/16 | Unknown at present
|
| 2023/05/20 |
Granpidam 20mg Film Coated Tablets
EU/1/16/1137/004
Accord Healthcare Ireland Ltd. | Sildenafil
| Similar alternative medicine authorised | Manufacturing delay | 2024/04/30 | 2024/07/21
| | 2024/05/09 |
Gyno-Pevaryl Once 150mg Vaginal Pessary
PA22650/006/001
KARO PHARMA AB
| Econazole nitrate
| Appropriate alternative medicine authorised
| Manufacturing delays | 2022/03/01 | Unknown at present |
| 2022/03/09 |
Heparin Sodium 10 I.U./ml flushing solution for maintenance of patency of intravenous devices
PA0281/230/001
Pinewood Laboratories Ltd
| Heparin sodium
| Comparable alternative medicine authorised
| Manufacturing delays | 2023/10/19 | Unknown at present | | 2024/01/09 |
Heparin sodium 1,000 I.U./ml Solution for injection or concentrate for solution for infusion, 5ml ampoules
PA0281/229/001
Pinewood Laboratories Ltd
| Heparin sodium
| Comparable alternative medicine authorised
| Manufacturing delays
| 2023/11/08 | Unknown at present | | 2024/01/09 |
Heparin sodium 1,000 I.U./ml Solution for injection or concentrate for solution for infusion, 5ml vials
PA0281/229/004
Pinewood Laboratories Ltd
| Heparin sodium
| Comparable alternative medicine authorised
| Manufacturing delay | 2023/10/19 | Unknown at present | | 2024/01/09 |
Hycamtin 1mg Powder for Concentrate for Solution for Infusion
EU/1/96/027/005 Sandoz Pharmaceuticals d.d. | Topotecan
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/04/15 | 2025/06/31 | HCP letter
| 2023/06/20 |
Hycamtin 4 mg Powder for concentrate for solution for infusion
EU/1/96/027/003
Sandoz Pharmaceuticals d.d.
| Topotecan
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2023/08/31 | 2025/06/31 |
HCP letter
| 2023/06/20 |
Hydrocortone 10mg Tablets
PA1986/054/001
Teva B.V. | Hydrocortisone | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/01 | 2024/09/29 | | 2024/07/22 |
Hypnovel 10mg/2ml Solution for Injection
PA2239/007/001
CHEPLAPHARM Arzneimittel GmbH
| Midazolam | Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/05/01 | Awaiting update | | 2024/06/13 |
| Hytrin 2mg Tablets
PA1142/005/002
Amdipharm Limited | Terazosin
| Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/07/05 | Awaiting update |
| 2024/06/13 |
Hytrin 10mg Tablets
PA1142/005/004
Amdipharm Limited
| Terazosin
| Comparable alternative medicine authorised | Manufacturing delay
| 2024/04/30 | 2024/09/30 | | 2024/06/18 |
Ibandronic Acid Teva 150mg Film Coated Tablets
EU/1/10/642/003-004
Teva B.V. | Ibandronic acid | Similar alternative medicine authorised | Regulatory issue | 2023/12/06 | 2024/11/15 | | 2024/02/09 |
Ibuprofen B. Braun 400 mg solution for infusion
PA0736/041/001
B. Braun Melsungen AG
| Ibuprofen
| Appropriate alternative medicine authorised
| Unexpected increase in demand
| 2024/07/23 | 2024/08/12 | | 2024/07/24 |
Icatibant Accord 30mg Solution for infusion in pre-filled syringe
EU/1/21/1567/001
Accord Healthcare S.L.U.
| Icatibant
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/03/12 | Awaiting update from the company | | 2024/03/11 |
Imdur 60 mg Prolonged-release Film-coated Tablets
PA2129/001/001
Topridge Pharma (Ireland) Limited
| Isosorbide mononitrate
| Similar alternative authorised | Unexpected increase in demand
(multiple countries affected) | 2023/09/29 | 2024/07/31 | | 2024/02/09 |
Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution
PA1986/082/001
Teva B.V.
| ipratropium &
salbutamol
| Appropriate alternative medicine authorised
| Unexpected increase in demand (multiple countries affected)
| 2024/7/22 | 2024/10/15 | | 2024/07/24 |
Isotretinoin 10mg Soft Capsules
PA0711/312/002
Rowex Ltd
| Isotretinoin
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected) | 2023/05/09 | Awaiting update from the company |
| 2024/06/13 |
Isotretinoin 20 mg soft capsules
PA0711/312/003
Rowex Ltd
| Isotretinoin
| Similar alternative medicine authorised
| Unexpected increase in demand | 2024/02/19 | Awaiting update from the company | | 2024/06/13 |
Ixiaro
EU/1/08/501/1-2
Intercell Austria AG
| Inactivated je virus
| No appropriate medicine authorised
| Awaiting information | 2022/10/01 | Awaiting update from the company
|
| 2024/02/14 |
Kay-Cee-L Syrup 7.5% w/v
PA22637/004/001
Elara Pharmaservices Europe Limited
| Potassium chloride
| Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2024/03/25 | Awaiting update from the company | | 2024/06/13 |
Klacid Paediatric Suspension 125mg/5ml, Granules for Oral Suspension
PA23355/013/005
Viatris Healthcare Limited | Clarithromycin
| Appropriate alternative medicine authorised
| Unexpected increase in demand | 2024/07/22 | 2024/10/31 | | 2024/07/17 |
Klacid 500mg Film Coated Tablets
PA23355/013/002
Viatris Healthcare Limited
| Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/01/07 | Awaiting update | | 2024/06/13 |
Klaram LA 500 mg Prolonged Release Tablets
PA2315/133/001
Mylan IRE Healthcare Limited
| Clarithromycin
| Similar alternative medicine authorised
| Unexpected increase in demand | 2022/11/28 | Awaiting update from the company |
| 2024/07/11 |
Kytril 1 mg/1 ml solution for injection
PA22657/003/001
Atnahs Pharma Netherlands B.V.
| Granisetron
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/05/14 | 2024/08/31 | | 2024/05/17 |
Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution
PA22680/001/003
Galen Pharma Ireland Limited
| Various | Similar alternative medicine authorised | Unexpected increase in demand | 2024/06/21 | 2024/08/01 | | 2024/07/05 |
Lexotan 1.5mg Tablets
PA2239/008/001
CHEPLAPHARM Arzneimittel GmbH
| Bromazepam
| Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/06 | Awaiting update | | 2024/06/13 |
Linezolid Teva 600 mg film-coated tablets
PA0749/204/001
Teva Pharma B.V.
| Linezolid
| Similar alternative medicine authorised
| Manufacturing delay
(multiple markets affected) | 2024/07/22 | 2024/08/12 | | 2024/07/09 |
Lioresal 5mg/5ml Oral Solution
PA0896/017/002
Novartis Ireland Limited
| Baclofen | Similar alternative medicine authorised | Manufacturing delay | 2024/04/01 | Awaiting update | | 2024/05/17 |
Lopid 300mg Capsules
PA0822/014/001
Pfizer Healthcare Ireland
| Gemfibrozil
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/02/12 | Awaiting update from the company |
| 2023/12/05 |
| Losartan Potassium 25 mg Film-coated Tablets PA2315/059/001
Accord Healthcare Ireland Ltd.
| Losartan
| Similar alternative medicine authorised
| Manufacturing delay | 2024/01/18 | Awaiting update from the company | | 2024/07/11 |
Lutinus 100mg Vaginal Tablets
PA1009/022/001
Ferring Ireland Ltd
| Progesterone | Appropriate alternative medicine authorised | Quality issue
(multiple markets impacted) | 2024/03/13 | 2024/07/31 | | 2024/03/20 |
Luveris 75IU Powder and solvent for solution for injection
EU/1/00/155/004
Merck Europe B.V.
| Lutropin alfa
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/06/17 | 2025/03/31 | HCP letter | 2024/06/05 |
MacroBID 100mg Prolonged Release Capsules
PA1142/033/001
Amdipharm Limited
| Nitrofurantoin | Similar alternative medicine authorised | Quality issue
(multiple countries impacted | 2024/03/27 | Awaiting information from the company | | 2024/03/27 |
Marcain 0.25% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection
PA1691/025/001
Aspen Pharma Trading Limited | Bupivacaine & adrenaline
| Appropriate alternative medicine authorised
| Manufacturing delay | 2023/01/31 | Unknown at present |
| 2024/02/26 |
Marcain 0.5% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection
PA1691/025/002
Aspen Pharma Trading Limited
| Bupivacaine & adrenaline
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2021/07/01 | Unknown at present |
| 2024/02/26 |
Marixino 10 milligram(s) Film-coated tablet
EU/1/13/820/002
KRKA, d.d., Novo mesto
| Memantine | Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/02/19 | Awaiting update | | 2024/06/13 |
Marixino 10 milligram(s) Film-coated tablet
EU/1/13/820/006
KRKA, d.d., Novo mesto
| Memantine | Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/02/19 | Awaiting update | | 2024/06/13 |
Maxilief Effervescent Tablets
PA0126/113/001
Clonmel Healthcare Ltd
| Paracetamol, Codeine & Caffeine
| Exact alternative medicine authorised
| Unexpected increase in demand | 2024/01/01 | 2024/08/01 |
| 2024/06/13 |
Memantine Accord 10mg Film Coated Tablets
28 pack and 56 pack size
EU/1/13/880/017-018
Accord Healthcare S.L.U.
| Memantine | Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/05/15 | 2024/10/01 | | 2024/05/09 |
Menopur 75IU Powder and Solvent for Solution or Injection
PA1009/015/001
Ferring Ireland Ltd
| Menotrophin
| Comparable alternative medicine authorised
| Quality issue
(multiple countries affected) | 2022/10/31 | Unknown at present
|
| 2022/11/04 |
Menopur 600IU Powder and Solvent for Solution or Injection
PA1009/015/002
Ferring Ireland Ltd
| Menotrophin
| Comparable alternative medicine authorised
| Quality issue
(multiple countries affected) | 2022/10/31 | Unknown at present
|
| 2022/11/04 |
Menopur 1200IU Powder and Solvent for Solution or Injection
PA1009/015/003
Ferring Ireland Ltd
| Menotrophin
| Comparable alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2022/10/31
| Unknown at present
| | 2022/11/04
|
Metformin Pinewood 100mg Film Coated Tablets
PA0281/213/003 Pinewood Laboratories Ltd | Metformin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/06/04 | 2024/07/31 | | 2024/06/13 |
Methotrexate 2.5mg Tablets
PA2315/062/001
Accord Healthcare Ireland Ltd. | Methotrexate | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/26 | Awaiting information from the company | | 2024/06/07 |
Methylthioninium Chloride Proveblue 5mg/ml solution for Injection
EU/1/11/682/001
Provepharm SAS
| Methylthionium
| No alternative medicine authorised
| Manufacturing delay
| 2022/10/03 | Awaiting update from the company |
| 2024/01/03 |
Midazolam 1mg/ml Solution for Injection or Infusion
PA2315/063/001 Accord Healthcare Ireland Ltd | Midazolam | Similar alternative medicine authorised | Manufacturing delay | 2024/04/10 | 2024/12/31 | | 2024/04/10 |
Milrinone 1mg/ml Solution for Injection/Infusion
PA0281/244/001
Pinewood Laboratories Ltd
| Milrinone
| Comparable alternative medicine authorised
| Manufacturing delay
| 2022/11/16 | Unknown at present |
| 2023/11/21 |
Minims Cyclopentolate Hydrochloride 1% w/v Eye Drops, solution PA23259/011/001 Bausch + Lomb Ireland Limited | Cyclopentolate hydrochloride
| Appropriate alternative medicine authorised
| API shortage/unavailability | 2024/05/01 | 2024/06/30 | | 2024/04/17 |
Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solution
PA23259/016/001
Bausch + Lomb Ireland Limited
| Phenylephrine
| Appropriate alternative medicine authorised | Manufacturing delays | 2024/05/15 | 2024/06/19 | | 2024/05/24 |
Mirap 30mg Film Coated Tablets
PA0711/062/002
Rowex Ltd
| Mirtazapine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/22 | Awaiting update | | 2024/04/29 |
Molipaxin 50 mg capsules
PA23229/011/001
Neuraxpharm Ireland Limited
| Trazodone
| Similar alternative medicine authorised
| Manufacturing delay
| 2024/07/12 | 2024/08/15 | | 2024/07/22 |
Molipaxin 150mg Film Coated Tablets
PA23229/011/003
Neuraxpharm Ireland Limited
| Trazodone
| Similar alternative medicine authorised | Manufacturing delay | 2024/07/01 | 2024/08/15 | | 2024/07/08 |
Mometasone 50 microgram/dose, Nasal spray, Suspension
PA0711/196/001
Rowex Ltd
| Mometasone
| Similar alternative medicine authorised
| Unexpected increase in demand | 2024/04/29 | 2024/09/01 | | 2024/05/27 |
Montelukast Bluefish 4mg Chewable Tablets
Bluefish Pharmaceuticals AB | Montelukast | Similar alternative medicine authorised | Unexpected increase in demand | 2023/12/13 | 2024/07/30 | | 2023/12/07 |
Montelukast Bluefish 5mg Chewable Tablets
Bluefish Pharmaceuticals AB | Montelukast | Similar alternative medicine authorised | Unexpected increase in demand | 2023/12/20 | 2024/07/30 | | 2023/12/07 |
Morphine Sulphate 30 mg/ml Solution for Injection
PA0073/020/004
Mercury Pharmaceuticals (Ireland) Ltd
| Morphine | Similar alternative medicine authorised | Quality issue | 2024/06/30 | 2024/08/15 | | 2024/06/18 |
Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or Infusion
PA0073/111/002
Mercury Pharmaceuticals Ireland
| Naloxone | Possible alternative medicine authorised | Unexpected increase in demand | 2024/05/02 | Awaiting update from the company | | 2024/07/18 |
NeoMercazole 20mg Tablets
PA1142/002/002
Amdipharm Limited
| Carbimazole
| Comparable alternative medicine authorised
| Manufacturing delay | 2023/05/22 | Awaiting update from the company
|
| 2024/04/22 |
Neurostil 300 mg capsules
PA0749/164/002
Teva Pharma B.V.
| Gabapentin
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected)
| 2024/06/10 | 2024/07/17 | | 2024/07/09 |
Nyxoid Nasal spray, solution in single-dose container
EU/1/17/1238/001
Mundipharma Corporation (Ireland) Limited
| Naloxone
| Possible alternative medicine authorised
| Unexpected increase in demand
| 2024/07/09 | 2024/09/30 | | 2024/06/27 |
Olmesartan Medoxomil 10mg Film-Coated Tablets
PA2315/113/001
Accord Healthcare Ireland Ltd.
| Olmesartan
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/03/12 | 2024/07/31 |
| 2024/07/11 |
Ondansetron 2mg/ml Solution for Injection or Infusion
PA2315/168/001
Accord Healthcare Ireland Ltd.
| Ondansetron | Similar alternative medicine authorised | Quality issue | 2023/10/17 | 2024/11/01 | | 2023/07/11 |
Opticrom allergy 2% w/v Eye Drops
PA23180/010/002
Opella Healthcare France SAS T/A Sanofi
| Sodium cromoglicate
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2022/01/27 | Awaiting update from the company |
| 2024/04/22 |
Oxycodone hydrochloride 50mg/ml Solution for Injection or Infusion
PA0281/235/002
Pinewood Laboratories Ltd
| Oxycodone
| Similar alternative medicine authorised
| Manufacturing delay | 2021/11/01 | Awaiting update |
| 2024/06/13 |
Pabrinex Intravenous High Potency Concentrate for Solution for Infusion
PA2288/001/001
Kyowa Kirin Holdings B.V.
| Ascorbic acid, riboflavin, pyridoxine, nicotinamide, thiamine & glucose | Comparable alternative medicine authorised | Manufacturing delay
| 2024/12/01 | 2025/07/01 | HCP letter
HSE clinical advice
| 2024/07/15 |
Palmeux 75mg prolonged-release suspension for injection in pre-filled syringe
PA1142/040/003
Amdipharm Limited
| Paliperidone | Similar alternative medicine authorised | Quality issue | 2024/06/24 | Awaiting update from the company | | 2024/07/03 |
Pantup Relief 20mg Gastro-Resistant Tablets
PA0711/142/003
Rowex Ltd
| Pantoprazole
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/03/27 | Awaiting update |
| 2024/07/08 |
Pegasys Solution for injection in pre-filled syringe 135mcg EU/1/02/221/005 pharmaand GmbH, (23086), (LOC-100073198), Taborstrasse 1, Vienna, 1020, Austria | Peginterferon-alfa-2a
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/08/01 | 2025/06/01 | | 2024/07/26 |
Pegasys Solution for injection in pre-filled syringe 180mcg
EU/1/02/221/008
pharmaand GmbH, (23086), (LOC-100073198), Taborstrasse 1, Vienna, 1020, Austria | Peginterferon-alfa-2a
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/08/01 | 2025/06/01 | | 2024/07/26 |
Perdamel 0.5mg Film Coated Tablets
PA0126/169/002
Clonmel Healthcare Ltd
| Risperidone | Similar alternative medicine authorised | Manufacturing delay | 2024/05/31 | 2024/11/15 | | 2024/05/22 |
Perdamel 1mg Film Coated Tablets
PA0126/169/003
Clonmel Healthcare Ltd
| Risperidone
| Similar alternative medicine authorised
| Manufacturing delay | 2024/07/01 | 2024/11/15 | | 2024/06/18 |
Perdamel 3 mg film-coated tablets
PA0126/169/005
Clonmel Healthcare Ltd | Risperidone
| Similar alternative medicine authorised
|
Manufacturing delay
(multiple countries affected)
| | 2024/08/01
| 2024/11/15
| | 2024/07/18 |
Ponstan Forte 500mg Film Coated Tablets
PA22643/001/002
Chemidex Pharma Limited
| Mefenamic acid
| Similar alternative medicine authorised
| Manufacturing delay | 2023/10/30 | 2024/08/15
|
| 2024/07/16 |
Prednisolone 5mg Soluble Tablets
PA1142/034/001
Amdipharm Limited
| Prednisolone
| Similar alternative medicine authorised | API unavailability | 2023/03/27 | 2024/09/31 | | 2024/01/16 |
Pregabalin Teva 50 mg capsules, hard
PA1986/001/002
Teva B.V.
| Pregabalin | Exact alternative medicine authorised | Manufacturing delay
(multiple countries affected)
| 2024/07/30 | 2024/10/25 | | 2024/07/23 |
Prucalopride 1mg Film Coated Tablets
PA0281/260/001
Pinewood Laboratories Ltd | Prucalopride | Appropriate alternative medicine authorised | Regulatory issue | 2023/12/31 | 2024/07/31 | | 2024/03/21 |
Prucalopride 2mg Film Coated Tablets
PA0281/260/002
Pinewood Laboratories Ltd | Prucalopride | Appropriate alternative medicine authorised | Regulatory issue | 2023/12/31 | 2024/07/31 | | 2024/03/21 |
Questran 4g/sachet powder for oral suspension
PA2239/005/001 CHEPLAPHARM Arzneimittel GmbH | Colestyramine resin
| Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/02/28 | Awaiting update | | 2024/06/13 |
Raporsin 4 mg prolonged-release tablets
PA2315/005/002
Accord Healthcare Ireland Ltd.
| Doxazosin
| Appropriate alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected)
| 2023/09/08 | 2024/08/30 | | 2024/07/11 |
Rasagiline Accord 1mg Tablets
PA2315/174/001
Accord Healthcare Ireland Ltd
| Rasagiline | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/30 | 2024/07/21 | | 2024/05/09 |
Rasagiline Bluefish 1mg tablets
PA1436/028/001
Bluefish Pharmaceuticals AB
| Rasagiline
| Similar alternative medicine authorised
| Regulatory issue
| 2022/07/01 | 2024/12/31 |
| 2023/08/23 |
Rasilez 150mg Film Coated Tablets
EU/1/07/405/022
Noden Pharma DAC
| Aliskiren | Appropriate alternative medicine authorised | API unavailability
(multiple countries affected) | 2024/04/01 | 2025/02/28 | | 2024/05/16 |
| Rasilez 300mg Film Coated Tablets
EU/1/07/405/032
Noden Pharma DAC | Aliskiren
| Appropriate alternative medicine authorised
| API unavailability
(multiple countries affected) | 2024/01/19 | 2025/01/31 | | 2024/05/16 |
Rekovelle 36 micrograms/1.08 mL solution for injection in a pre-filled pen
EU/1/16/1150/005
Ferring Pharmaceuticals A/S
| Follitropin delta | Similar alternative medicine authorised | Unexpected increase in demand | 2024/06/14 | 2024/07/22 | HCP letter | 2024/06/13 |
Relistor 12 mg/0.6ml Solution for Injection
EU/1/08/463/001
Bausch Health Ireland Limited | Methylnaltrexone
| Comparable alternative medicine authorised
| Manufacturing delay | 2023/07/14 | Awaiting update from the company |
| 2024/04/24 |
Remifentanil Noridem 2 mg powder for concentrate for solution for injection or infusion
PA1122/014/002
Noridem Enterprises Limited
| Remifentanil
| Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/04/25 | Awaiting update | | 2024/06/13 |
Remifentanil Noridem 5mg powder for concentrate for solution for injection or infusion
PA1122/014/003
Noridem Enterprises Limited
| Remifentanil
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/04/18 | Awaiting update from the company | | 2024/04/24 |
Renvela 0.8g powder for oral suspension
EU/1/09/521/008 Genzyme Europe B.V. | Sevelamer
| Appropriate alternative medicine authorised | Manufacturing delay and shipping delay | 2024/05/30 | 2024/07/14 | | 2024/06/12 |
Retrovir 10 mg/ml IV concentrate for solution for infusion
PA22575/001/003
ViiV Healthcare BV
| Zidovudine
| Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/06/24 | 2024/08/12 |
| 2024/07/19 |
Ritalin LA 40mg prolonged-release capsules
PA1972/002/004
InfectoPharm Arzneimittel und Consilium Gmbh
| Methylphenidate
| Similar alternative medicine authorised | Unexpected increase in demand | 2024/07/29 | 2024/08/12 | | 2024/07/17 |
Rosuvastatin 40mg Film Coated Tablets
PA2315/068/004
Accord Healthcare Ireland Ltd.
| Rosuvastatin
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/10/16 | 2024/07/31
|
| 2024/03/21 |
Rosuvastatin 5mg Film Coated Tablets
PA2315/068/001
Accord Healthcare Ireland Ltd.
| Rosuvastatin
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2023/10/16 | 2024/07/31 | | 2024/03/21 |
Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution
PA1986/086/001
Teva B.V.
| Salbutamol | Appropriate alternative medicine authorised | Manufacturing delay
(multiple markets affected) | 2024/04/26 | 2024/11/01 | | 2024/05/03 |
Salamol Steri-Neb 5mg/2.5 ml Nebuliser Solution
PA1986/086/002
Teva B.V.
| Salbutamol
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/09/21 | 2024/11/01 |
| 2024/05/03 |
Saline Steri-Neb 0.9% w/v Nebuliser Solution
PA1986/087/001
Teva B.V.
| Sodium chloride | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/02/25 | 2024/08/15 | | 2024/06/07
|
Sandimmun 100mg Soft Capsules
PA0896/027/004
Novartis Ireland Limited
| Ciclosporin
| Similar alternative medicine authorised | Manufacturing delay | 2024/05/16 | 2024/06/06 | | 2024/05/22 |
Serlan 50mg Film Coated Tablets
PA0711/065/001
Rowex Ltd | Sertraline | Similar alternative medicine authorised | Manufacturing delay | 2024/06/27 | 2024/09/30 | | 2024/06/14 |
Six Plus Parapaed Paracetamol Oral Suspension 250mg/5ml
PA0281/002/003
Pinewood Laboratories Ltd
| Paracetamol
| Appropriate alternative medicine authorised
| Quality issue | 2022/01/01 | Awaiting update from the company |
| 2023/04/03 |
Solifenacin succinate 10mg film-coated tablets
PA2315/118/002
Accord Healthcare Ireland Ltd. | Solifenacin
| Similar alternative medicine authorised
| API unavailability
| 2023/09/30 | 2024/10/31
| | 2024/07/11 |
Solpadeine Soluble Tablets
12 pack
PA1186/011/001
Chefaro Ireland DAC
| Paracetamol & codeine & caffeine
| Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2023/12/29 | Awaiting update from the company | | 2024/07/25 |
Solpadeine Soluble Tablets
24 pack
PA1186/011/001
Chefaro Ireland DAC
| Paracetamol & codeine & caffeine
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/07/25 | 2024/09/01 | | 2024/07/26 |
Solpadeine Soluble Tablets
60 pack
PA1186/011/001
Chefaro Ireland DAC
| Paracetamol & codeine & caffeine | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected)
| 2024/04/10 | Awaiting update from the company |
| 2024/07/25 |
Sublimaze 50 micrograms/ml solution for injection
PA22583/002/001
Piramal Critical Care B.V.
| Fentanyl
| Appropriate alternative medicine authorised
| Manufacturing delay
| 2023/05/01 | Awaiting update from the company | | 2023/11/16 |
| Suboxone 2mg/0.5mg Sublingual Tablets
EU/1/06/359/001 Indivior Europe Limited | Buprenorphine & naloxone
| Comparable alternative medicine authorised | Manufacturing delay | 2024/03/05 | Awaiting update | | 2024/06/13 |
Teicoplanin 200 mg Powder and Solvent for Solution for injection/infusion or oral solution
PA1122/009/001
Noridem Enterprises Limited
| Teicoplanin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/29 | Awaiting update | | 2024/06/13 |
Telmisartan 20mg Tablets
PA2315/014/001
Accord Healthcare Ireland Ltd.
| Telmisartan
| Similar alternative medicine authorised
| Manufacturing delay
(Multiple countries affected)
| 2023/09/08 | 2025/01/01 | | 2024/02/19 |
Telmisartan Rowa 20 mg tablets
PA0074/078/001
Rowa Pharmaceuticals Limited
| Telmisartan | Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/01/22 | Awaiting update from the company | | 2024/07/05 |
Telmisartan 40mg Tablets
PA2315/014/002
Accord Healthcare Ireland Ltd.
| Telmisartan | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/01/02 | 2025/01/01 | | 2024/02/19 |
Telmisartan 80mg Tablets
PA2315/014/003
Accord Healthcare Ireland Ltd.
| Telmisartan | Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/01/02 | 2025/01/01 | | 2024/02/19 |
Telmisartan Rowa 40 mg tablets
PA0074/078/002 Rowa Pharmaceuticals Limited | Telmisartan
| Similar alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/06/24 | Awaiting update from the company | | 2024/07/09 |
Telmisartan Rowa 80 mg tablets
PA0074/078/003
Rowa Pharmaceuticals Limited
|
Telmisartan | Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/01/29 | 2024/08/30
| | 2024/07/11 |
Temgesic 200 microgram Sublingual Tablets
PA23460/001/001
Eumedica Pharmaceuticals GmbH
| Buprenorphine
| Appropriate alternative medicine authorised
| Manufacturing delay
| 2024/02/06 | Awaiting update from the company | | 2024/03/04 |
Temozolomide Accord 20mg Capsules
EU/1/10/615/005
Accord Healthcare S.L.U.
| Temozolomide
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/02/19 | Awaiting update from the company | | 2024/05/14 |
Temozolomide Teva 100mg Capsules, hard
EU/1/09/606/005-006
Teva B.V. | Temozolomide
| Similar alternative medicine authorised | Manufacturing delay | 2024/07/10 | 2024/11/15 | | 2024/07/24 |
Tenofovir disoproxil Mylan 245mg Film Coated Tablets
EU/1/16/1129/005
Mylan Pharmaceuticals Limited | Tenofovir disoproxil | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/04 | Awaiting update from the company | | 2024/06/18 |
TEVETEN 400 mg, film-coated tablets
PA2010/017/001
Mylan IRE Healthcare Limited
| Eprosartan
| Appropriate alternative medicine authorised
| Manufacturing delay | 2024/02/26 | Awaiting update | | 2024/06/13 |
Tobramycin 40mg/ml Solution for Injection
80mg/2ml presentation
PA0822/207/001
Pfizer Healthcare Ireland
| Tobramycin | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/05 | 2024/11/13 | HCP letter | 2024/06/28 |
Tolura 40 mg tablets
EU/1/10/632/009
KRKA, d.d., Novo mesto
| Telmisartan
| Similar alternative medicine authorised
| Awaiting information from the company | 2024/02/16 | Awaiting update | | 2024/06/13 |
Trandate 100mg Film-Coated Tablets
PA1638/006/002
RPH Pharmaceuticals AB
| Labetalol
| Similar alternative medicine authorised
| Manufacturing delay
(Ireland & UK)
| 2024/08/01 | 2025/01/01 | | 2024/07/23 |
Tymbrineb 300 mg/5 ml Nebuliser Solution
PA0749/117/001
Teva Pharma B.V. | Tobramycin | Similar alternative medicine authorised | Shipping delay
(multiple countries affected) | 2024/05/28 | 2024/08/15 | | 2024/05/14 |
Ultiva 1mg Powder for Concentrate for Solution for Infusion
PA1691/032/001
Aspen Pharma Trading Limited
| Remifentanil
| Appropriate alternative medicine authorised | Shipping delay | 2024/05/17 | Awaiting update from the company | | 2024/06/13 |
Ultiva 2mg Powder for Concentrate for Solution for Infusion
PA1691/032/002
Aspen Pharma Trading Limited
| Remifentanil | Appropriate alternative medicine authorised
| Shipping delay | 2024/04/26 |
Awaiting update from the company
| | 2024/06/13 |
Valsartan/Hydrochlorothiazide 160mg/12.5mg Film Coated Tablets
PA2315/181/002
Accord Healthcare Ireland Ltd
|
Valsartan & hydrochlorothiazide
| Similar alternative medicine authorised | Manufacturing delay | 2023/09/01 | Awaiting update from the company | | 2024/03/21
|
Valsartan/Hydrochlorothiazide 160 mg/ 25 mg Film-coated Tablets
PA2315/181/003
Accord Healthcare Ireland Ltd
| Valsartan & hydrochlorothiazide
| Similar alternative medicine authorised
| Manufacturing delay
| 2023/12/31 | Awaiting update from the company | | 2024/07/11
|
Vancomycin Viatris 500 mg, powder for solution for infusion
PA23266/004/001
Viatris limited | Vancomycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/07/01 | 2024/08/18 | | 2024/07/11 |
Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution
PA1122/008/002
Noridem Enterprises Limited
| Vancomycin
| Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/07/02 | 05/08/2024 | | 2024/06/26 |
Venlafex 75mg Prolonged Release Capsules
PA1347/036/002
KRKA, d.d., Novo mesto
| Venlafaxine
| Similar alternative medicine authorised | Manufacturing delays | 2024/05/01 | Awaiting update | | 2024/06/13 |
Visudyne Powder for Solution for Infusion
EU/1/00/140/001
CHEPLAPHARM Arzneimittel GmbH
| Verteporfin
| Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2023/10/11 | 2024/07/29 | | 2024/06/21
|
Warfarin Teva 1mg Tablets
PA2050/001/002
Sun Pharmaceutical Industries Europe B.V.
| Warfarin | Appropriate alternative medicine authorised | Quality issue
(multiple countries affected) | 2024/05/06 | 2024/09/16 | HCP letter
| 2024/07/24 |
Warfarin Teva 3mg Tablets
PA2050/001/005
Sun Pharmaceutical Industries Europe B.V.
| Warfarin | Appropriate alternative medicine authorised
| Quality issue
(multiple countries affected)
| 2024/07/05 | 2024/09/16 | HCP letter
| 2024/07/24
|
Warfarin Teva 5mg Tablets
PA2050/001/006
Sun Pharmaceutical Industries Europe B.V.
| Warfarin | Appropriate alternative medicine authorised | Quality issue
(multiple countries affected) | 2024/05/15 | 2024/09/16
| HCP letter
| 2024/07/24
|
Xylocaine 2% with Adrenaline (Epinephrine) (1:200,000) Solution for Injection
PA1691/027/001
Aspen Pharma Trading Limited
| Adrenaline & lidocaine | Appropriate alternative medicine authorised | Quality issue | 2024/04/01 | 2024/07/31 | | 2024/03/21 |
Zacin 0.025% w/w Cream
PA1986/090/001
Teva B.V.
| Capsaicin
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2023/08/20 | 2025/01/01 | | 2024/06/07 |
Zaditen 1mg/5ml oral solution
PA2206/004/001
Alfasigma S.p.A
| Ketotifen | Appropriate alternative medicine authorised
| Manufacturing delay | 2024/01/01 | Awaiting update from the company | | 2024/07/12 |
Zindaclin 1% Gel
PA23139/001/001
Canute Pharma (Ireland) Limited
| Clindamycin
| Similar alternative medicine authorised
| Distribution issue | 2022/12/01 | Awaiting update from the company |
| 2024/07/12 |
Zinnat 250mg/5ml Granules for Oral Suspension
PA23311/003/001
Sandoz Pharmaceuticals d.d.
| Cefuroxime
| Appropriate alternative medicine authorised
| Unexpected increase in demand | 2023/04/01 | Awaiting update from the company |
| 2024/06/14 |
Zinnat 125 mg/5 ml granules for Oral Suspension
PA23311/003/005
Sandoz Pharmaceuticals d.d.
| Cefuroxime
| Appropriate alternative medicine authorised
|
Unexpected increase in demand
| 2023/04/01 | Awaiting update from the company | | #2025/06/14 |
Zinnat 500mg Film Coated Tablets
PA23311/003/004
Sandoz Pharmaceuticals d.d.
| Cefuroxime
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple markets impacted) | 2024/06/10 | Awaiting update from the company | | 2024/06/14 |
Zonisamide Neuraxpharm 25 mg tablets
PA23229/006/001
Neuraxpharm Ireland Limited
| Zonisamide
| Similar alternative medicine authorised | Manufacturing delay | 2024/06/07 | 2024/09/01 | | 2024/05/29 |
Zofran 4mg/5ml Syrup
PA0711/327/002
Rowex Ltd
| Ondansetron
| Appropriate alternative medicine authorised
| Manufacturing delay
| 2022/12/15 | Awaiting update from the company | | 2024/07/12 |
Zofran 4 mg film-coated tablets
PA0711/327/003
Rowex Ltd
| Ondansetron
| Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/29 | 2024/09/30 | | 2024/07/12 |
Zofran 4mg/2ml Solution for Injection or Infusion
PA0711/327/001
Rowex Ltd
| Ondansetron
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries impacted)
| 2024/04/29 | 2024/09/01 | | 2024/07/18 |
Zypadhera Powder and solvent for prolonged-release suspension for injection
300mg vial presentation
EU/1/08/479/002
Eli Lilly Nederland B.V.
| Olanzapine | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/12 | Awaiting update | | 2024/05/15 |