Abilify 7.5mg/ml Solution for Injection
EU/1/04/276/036
Otsuka Pharmaceutical Netherlands B.V
|
Aripiprazole
| Appropriate alternative medicine authorised | Quality issue
(multiple countries affected) | 2024/02/27 | Awaiting update from the company | | 2024/04/30 |
Abstral 600 microgram sublingual tablets
PA2288/004/006
Kyowa Kirin Holdings B.V.
| Fentanyl | Similar alternative medicine authorised | Unexpected increase in demand
| 2024/04/08 | 2024/06/07 | | 2024/04/22 |
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 |
Adcortyl Intra-articular/Intradermal Injection 10 mg/ml, Suspension for Injection, 5ml
PA0002/018/003
Bristol-Myers Squibb Pharmaceuticals uc
|
Triamcinolone
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/05/09 | 2024/05/26 | HCP letter | 2024/04/26 |
Adenosine 3 mg/ml solution for injection in pre-filled syringe
6mg/2ml presentation
PA2059/004/001
Fresenius Kabi Deutschland GmbH
| Adenosine | Appropriate alternative medicine authorised | Quality issue
(impacting multiple markets) | 2024/03/22 | 2024/04/21 | | 2024/03/27 |
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
| | 2024/02/19 |
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
| | 2024/02/19 |
Alprazolam 0.25 mg Tablets
PA0711/140/001
Rowex Ltd
| Alprazolam
| Appropriate alternative medicine authorised
| Unexpected increase in demand | 2023/02/28 | 2024/05/31
|
| 2024/05/07 |
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 | 2024/07/01 | | 2024/04/03
|
Antabuse 400mg Effervescent Tablets
PA1986/110/001
Teva B.V.
| Disulfiram
| Comparable alternative medicine authorised
| API unavailability
(multiple countries affected) | 2022/07/25 | 2024/06/01 | | 2023/11/13 |
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 Accord 30mg tablets
EU/1/15/1045/020
Accord Healthcare S.L.U
| Aripiprazole | Similar alternative medicine authorised | API unavailability | 2024/04/30 | 2024/10/01 | | 2024/05/09 |
Aripiprazole Teva 30mg tablets
PA1986/019/004
Teva B.V. | Aripiprazole | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/05/14 | 2024/07/22 | | 2024/05/01 |
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 |
Atenomel 25mg Tablets
PA0126/069/003
Clonmel Healthcare Ltd
| Atenolol | Similar alternative medicine authorised | Quality issue | 2023/10/16 | 2024/06/30 | | 2024/01/10 |
Atenomel 50mg Tablets
PA0126/069/001
Clonmel Healthcare Ltd
| Atenolol
| Similar alternative medicine authorised
| Quality issue | 2022/11/30 | 2024/06/30 |
| 2023/12/14 |
Atenomel 100mg Tablets
PA0126/069/002
Clonmel Healthcare Ltd
| Atenolol | Similar alternative medicine authorised | Quality issue | 2024/01/16 | Awaiting update from the company
| | 2024/02/06 |
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
| 2024/05/07 |
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
| 2024/05/07 |
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
| 2024/05/07 |
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
| 2024/05/07 |
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 |
Azyter 15 mg/g eye drops, solution, in single-dose container
PA1107/004/001
Laboratoires Thea
| Azithromycin | Comparable alternative medicine authorised | Manufacturing delay | 2024/04/25 | 2024/05/23 | | 2024/05/07 |
Baclopar 10mg Tablets
PA0577/195/001
McDermott Laboratories Ltd., T/A Gerard Laboratories
| Baclofen
| Exact alternative medicine authorised
| Manufacturing delay | 2023/06/26 | 2024/05/26 | | 2024/02/02 |
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 Ointment 0.1% w/w
(30g presentation)
PA1077/001/002
GlaxoSmithKline (Ireland) Limited
| Betamethasone | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/03/29 | 2024/05/31 | | 2024/03/20 |
Betnovate Ointment 0.1% w/w
(100g presentation)
PA1077/001/002
GlaxoSmithKline (Ireland) Limited
| Betamethasone | Appropriate alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2024/04/19 | 2024/05/06 | | 2024/04/05 |
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 |
| 2024/02/02 |
Bisoprolol 2.5mg Film Coated Tablets
PA2315/194/001
Accord Healthcare Ireland Ltd.
| Bisoprolol | Similar alternative medicine authorised | Manufacturing delay | 2023/11/27 | Awaiting update from the company | | 2024/04/25 |
Brinzolamide 10mg/ml Eye Drops, Suspension
PA2315/149/001
Accord Healthcare Ireland Ltd.
| Brinzolamide | Similar alternative medicine authorised | Manufacturing delay | 2024/02/23 | 2024/04/30 | | 2024/02/09 |
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 |
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 |
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 | 2024/07/15 | | 2024/05/07 |
Clarithromycin 250mg Film Coated Tablets
PA2050/002/001
Sun Pharmaceutical Industries Europe B.V
| Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/25 | 2024/05/31 | | 2024/03/26 |
Clarithromycin 500mg Film Coated Tablets
PA2050/002/002
Sun Pharmaceutical Industries Europe B.V
| Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/02/20 | 2024/05/31 | | 2024/03/26 |
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 |
Clonocid 500mg Film Coated Tablets
PA0126/136/002
Clonmel Healthcare Ltd
| Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/04 | 2024/04/20 | | 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 | 2024/06/21 | | 2024/04/24 |
Co-Amoxiclav TEVA 1000mg/100 mg Powder for Solution for Injection/Infusion
PA0749/011/002
Teva Pharma B.V.
|
Amoxicillin & clavulanic acid
| Similar alternative medicine authorised | Awaiting information from the company | 2024/04/19 | 2024/05/10 | | 2024/04/24 |
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
|
| 2024/03/31 |
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 | 2024/05/01 | | 2024/04/03 |
Cozatan 50mg Film Coated Tablets
PA0126/167/001
Clonmel Heathcare Limited.
| Losartan | Similar alternative medicine authorised | API unavailability | 2024/02/23 | 2024/04/15 | | 2024/03/04 |
Creon 10000 Gastro Resistant Capsules
PA23355/006/001
Viatris Healthcare Limited
|
Pancreas powder, lipase, amylase & protease
| Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/05/06 | 024/06/31 | | 2024/05/02 |
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 | 2024/06/30 | | 2024/05/01 |
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 | 2024/04/30 | | 2024/02/02 |
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 |
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 | 2024/03/20 |
| 2024/03/04 |
Dolmatil 200mg Tablets
PA23229/010/001
Neuraxpharm Ireland Limited
| Sulpiride
| Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/13 | 2024/05/30 | | 2024/04/24 |
Donepezil 5mg Film-coated Tablets
PA2315/033/001
Accord Healthcare Ireland Ltd.
| Donepezil
| Similar alternative medicine authorised
| Manufacturing delay | 2023/07/01 | 2024/05/31 | | 2024/03/21 |
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 |
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 | 2024/05/15 | | 2024/03/25 |
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 | 2024/06/01 | | 2024/01/29 |
ENAP 10mg Tablets
PA0711/028/002
Rowex Ltd
| Enalapril
| Similar alternative medicine authorised
| Manufacturing delay
| 2024/01/29 | 2024/05/31 | | 2024/05/07 |
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 | 2024/04/07 | | 2024/02/15 |
Erwinase 10 000 U powder for solution for injection/infusion
PA23208/001/001
Porton Biopharma Limited
| Crisantaspase
| Comparable alternative medicine authorised
| Unexpected increase in demand | 2024/03/04 | 2024/06/01 | | 2024/03/05 |
Erythrocin 500 mg Tablets
PA1142/008/003
Amdipharm Limited
| Erythromycin
| Similar alternative medicine authorised | Manufacturing delay | 2024/05/06 | 2024/06/31 | | 2024/04/22 |
Esomeprazole 40mg Gastro Resistant Tablets
PA2315/127/004
Accord Healthcare Ireland Ltd.
| Esomeprazole
| Similar alternative medicine authorised
| Manufacturing delay | 2023/07/15 | Awaiting update from the company |
| 2024/04/25 |
Estradot 37.5 micrograms/24 hours, transdermal patch
PA0896/010/001
Novartis Ireland Limited
| Estradiol
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 03/02/2024 | 2024/05/21 | HCP letter
| 2024/04/26 |
Ezetimibe Rowa 10mg Tablets
PA0074/074/001
Rowa Pharmaceuticals Ltd | Ezetimibe | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/27 | 2024/05/31 | | 2024/04/03 |
Ezetimibe Teva 10mg Tablets
PA1986/012/001
Teva B.V.
| Ezetimibe | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/21 | 2024/05/15 | | 2024/04/24 |
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 | 2024/06/03 | | 2024/04/24 |
Ezetimibe/Simvastatin 10mg/80mg Tablets
PA1986/067/003
Teva B.V. | Ezetimibe & simvastatin | Similar alternative medicine authorised | Awaiting information from the company | 2024/05/15 | 2024/07/08 | | 2024/05/01 |
Famotidine Clonmel 20mg Film Coated Tablets
PA0126/344/001
Clonmel Healthcare Ltd | Famotidine | Similar alternative medicine authorised | Quality issue | 2024/03/21 | Awaiting update from the company | | 2024/05/07 |
Famotidine Clonmel 40mg Film Coated Tablets
PA0126/344/002
Clonmel Healthcare Ltd
| Famotidine | Similar alternative medicine authorised | Quality issue | 2024/01/09 | Awaiting update from the company | | 2024/05/07 |
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 |
Finasteride 5mg Film Coated Tablets
PA2315/089/001
Accord Healthcare Ireland Ltd.
| Finasteride | Similar alternative medicine authorised | Regulatory issue | 2024/05/15 | 2024/06/01 | | 2024/05/09 |
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 |
Flucloxacillin 500 mg powder for solution for injection/infusion
PA2059/069/001
Fresenius Kabi Deutschland GmbH
| Flucloxacillin
| Appropriate alternative medicine authorised
| Quality issue | 2023/10/11 | 2024/05/15 | | 2024/05/03 |
Fluconazole 50mg hard capsule
PA2315/090/001
Accord Healthcare Ireland Ltd
| Fluconazole | Similar alternative medicine authorised | Manufacturing delay | 2023/12/25 | 2024/04/30 | | 2023/12/19 |
Fluconazole 150 mg hard capsule
PA2315/090/002
Accord Healthcare Ireland Ltd.
| Fluconazole
| Similar alternative medicine authorised
| API unavailability | 2023/08/01 | Unknown at present |
| 2024/03/31 |
Fluconazole 200 mg hard capsule
PA2315/090/003
Accord Healthcare Ireland Ltd.
| Fluconazole
| Similar alternative medicine authorised
| API unavailability | 2023/08/01 | Unknown at present |
| 2024/03/31 |
Flucol 150mg Hard Capsules
PA0711/057/003
Rowex Ltd
| Fluconazole | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/29 | 2024/05/01 | | 2024/04/29 |
Flucol 200mg Hard Capsules
PA0711/057/004
Rowex Ltd
| Fluconazole | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/29 | 2024/06/30 | | 2024/04/29 |
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 | 2024/06/03 | | 2024/05/07 |
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 | 2024/05/07 | 2024/05/27 | | 2024/05/07 |
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 |
Fulvestrant Teva 250 mg Solution for Injection in Pre-filled Syringe
PA1986/011/001
Teva B.V.
| Fulvestrant
| Similar alternative medicine authorised | Manufacturing delay | 2024/04/10 | 2024/06/24 | | 2024/05/01 |
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 | 2024/09/01 | Gamanil shortage letter | 2023/12/15 |
Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution
PA1410/004/001
Bayer Limited
| Various | Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries impacted)
| 2024/03/29 | 2024/05/27 | HCP letter
| 2024/03/20 |
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 | 2024/07/01 |
| 2024/04/12 |
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 | 2024/07/01 | | 2024/02/06 |
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 | 2024/07/01 |
| 2024/02/06
|
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 |
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 |
Hydrea 500mg Hard Capsules
PA2239/021/001
CHEPLAPHARM Arzneimittel GmbH
|
Hydroxycarbamide
| Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/04/13 | 2024/05/30 | | 2024/04/10 |
Hydrocortone 10mg Tablets
PA1986/054/001
Teva B.V. | Hydrocortisone | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/04/01 | 2024/07/01 | | 2024/03/25 |
Hydroxocobalamin 1 mg/ml solution for injection
PA1770/002/001
G.L. Pharma GmbH
| Hydroxocobalamin | Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/03/25 | 2024/04/22 | | 2024/03/26 |
Hypnovel 10mg/2ml Solution for Injection
PA2239/007/001
CHEPLAPHARM Arzneimittel GmbH
| Midazolam | Appropriate alternative medicine authorised | Unexpected increase in demand | 2024/05/01 | 2024/05/17 | | 2024/05/01 |
| Hytrin 2mg Tablets
PA1142/005/002
Amdipharm Limited | Terazosin
| Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/07/05 | 2024/06/01 |
| 2024/04/22 |
Hytrin 10mg Tablets
PA1142/005/004
Amdipharm Limited
| Terazosin
| Comparable alternative medicine authorised | Manufacturing delay
| 2024/04/30 | 2024/06/31 | | 2024/04/22 |
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 |
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 |
Imigran Ftab 50mg Film Coated Tablets
PA1077/008/006
GlaxoSmithKline (Ireland) Limited
| Sumatriptan | Similar alternative medicine authorised | Quality issue
(multiple countries affected) | 2024/01/24 | Awaiting update from the company | | 2024/04/05 |
Ipramol Steri-Neb 0.5mg / 2.5mg per 2.5ml Nebuliser Solution
PA1986/082/001
Teva B.V.
| Ipratropium & salbutamol
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2024/03/10 | 2024/07/15 | | 2024/05/03 |
Ipratropium Steri-Neb 250 micrograms/ml Nebuliser solution
(250mg presentation)
PA1986/083/001
Teva B.V.
| Ipratropium | Appropriate alternative medicine authorised | Manufacturing delay | 2023/11/06 | 2024/07/15 | | 2024/05/03 |
Ipratropium Steri-Neb 250 micrograms/ml Nebuliser solution
(500mg presentation)
PA1986/083/001
Teva B.V.
| Ipratropium | Appropriate alternative medicine authorised | Manufacturing delay
(multiple countries affected) | 2024/01/14 | 2024/07/15 | | 2024/05/03 |
Isotretinoin 10mg Soft Capsules
PA0711/312/002
Rowex Ltd
| Isotretinoin
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple countries affected) | 2023/05/09 | 2024/06/01 |
| 2024/05/02 |
Isotretinoin 20 mg soft capsules
PA0711/312/003
Rowex Ltd
| Isotretinoin
| Similar alternative medicine authorised
| Unexpected increase in demand | 2024/02/19 | 2024/06/01 | | 2024/05/02 |
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 | | 2024/04/30 |
Klacid 500mg Film Coated Tablets
PA23355/013/002
Viatris Healthcare Limited
| Clarithromycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/01/07 | 2024/05/31 | | 2024/01/05 |
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 | 2024/04/30 |
| 2024/02/08 |
Letrozole Teva 2.5mg Film Coated Tablets
PA0749/085/001 Teva Pharma B.V. | Letrozole
| Similar alternative medicine authorised
| Awaiting information
| 2023/09/08 | 2024/06/03 | | 2024/04/12 |
Lexotan 1.5mg Tablets
PA2239/008/001
CHEPLAPHARM Arzneimittel GmbH
| Bromazepam
| Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/06 | 2024/04/14 | | 2024/04/03 |
Linezolid 600mg Film Coated Tablets
PA2315/104/001
Accord Healthcare Ireland Ltd.
| Linezolid | Similar alternative medicine authorised | Manufacturing delay | 2024/04/30 | 2024/06/01 | | 2024/05/09 |
Lioresal 5mg/5ml Oral Solution
PA0896/017/002
Novartis Ireland Limited
| Baclofen | Similar alternative medicine authorised | Manufacturing delay | 2024/04/01 | 2024/05/03 | | 2024/03/20 |
Lioresal 10 mg Tablets
PA0896/017/001
Novartis Ireland Limited
| Baclofen | Comparable alternative medicine authorised | Manufacturing delay
(multiple countries impacted)
| 2024/03/11 | 2024/05/03 | | 2024/03/11 |
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 | | 2024/03/21 |
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 |
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 | 2024/04/07 | | 2024/02/22 |
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 | 2024/04/14 | | 2024/02/22 |
Maxilief Effervescent Tablets
PA0126/113/001
Clonmel Healthcare Ltd
| Paracetamol, Codeine & Caffeine
| Exact alternative medicine authorised
| Unexpected increase in demand | 2024/01/01 | 2024/04/30 |
| 2024/02/13 |
MEFAC 500mg Film Coated Tablets
PA0074/015/002
Rowa Pharmaceuticals Limited
| Mefenamic acid
| Appropriate alternative medicine authorised | Manufacturing delay | 2024/02/18 | Awaiting update from the company | | 2024/03/05 |
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 |
Memantine Accord 20mg Film Coated Tablets
EU/1/13/880/021
Accord Healthcare S.L.U.
| Memantine | Appropriate alternative medicine authorised | API unavailability | 2023/12/08 | Awaiting update from the company | | 2024/05/09 |
Memantine Clonmel 10mg Film Coated Tablets
28 pack
PA0126/255/002
Clonmel Healthcare Ltd. | Memantine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/01/29 | 2024/04/30 | | 2024/03/04 |
Memantine Clonmel 10mg Film Coated Tablets
56 pack
PA0126/255/002
Clonmel Healthcare Ltd.
| Memantine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/02/20 | 2024/04/30 | | 2024/03/04 |
Memantine Clonmel 10mg/ml Oral Solution
(50ml presentation only)
PA0126/255/001
Clonmel Healthcare Ltd
| Memantine
| Appropriate alternative medicine authorised
| Regulatory issue | 2023/06/12 | 2024/04/15
|
| 2024/02/27 |
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
|
Methotrexate 2.5mg Tablets
PA1142/030/001
Amdipharm Limited
| Methotrexate | Similar alternative medicine authorised | Awaiting information from the company | 2023/12/31 | 2024/05/17 | | 2024/04/26 |
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 | | 2024/03/12 |
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 |
Mirap 15mg Film Coated Tablets
PA0711/062/001
Rowex Ltd
| Mirtazapine | Similar alternative medicine authorised | Unexpected increase in demand
(multiple countries impacted) | 2024/03/18 | 2024/05/31 | | 2024/04/02 |
Mirap 30mg Film Coated Tablets
PA0711/062/002
Rowex Ltd
| Mirtazapine | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/22 | 2024/05/31 | | 2024/04/29 |
Mometasone 50 microgram/dose, Nasal spray, Suspension
PA0711/196/001
Rowex Ltd
| Mometasone
| Similar alternative medicine authorised
| Unexpected increase in demand | 2024/04/29 | Awaiting update from the company | | 2024/04/29 |
Montelukast Paediatric 5mg Chewable Tablets
PA2315/110/002
Accord Healthcare Ireland Ltd. | Montelukast | Similar alternative medicine authorised | Awaiting information | 2024/04/30 | 2024/07/01 | | 2024/05/09 |
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 |
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 | 2024/07/01 | | 2024/05/01 |
Naltrexone Hydrochloride 50mg film-coated tablets
PA2315/111/001
Accord Healthcare Ireland Ltd.
| Naltrexone | Comparable alternative medicine authorised | Manufacturing delay | 2023/11/06 | Awaiting update from the company | | 2024/03/21 |
Neo-Cytamen 1000 micrograms/ml Solution for Injection
PA1638/004/001
RPH Pharmaceuticals AB
| Hydroxocobalamin
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries affected) | 2023/09/25 | 2024/07/31 |
| 2023/09/21 |
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 |
| Nyxoid Nasal spray, solution in single-dose container EU/1/17/1238/001 Mundipharma Corporation (Ireland) Limited | Naloxone
| Appropriate alternative medicine authorised | Unexpected increase in demand
(multiple countries affected) | 2024/03/25 | 2024/05/31 | | 2024/03/13 |
Olmesartan/Amlodipine Clonmel 40 mg/10 mg film-coated tablets
PA0126/293/003
Clonmel Healthcare Ltd
| Olmesartan | Similar alternative medicine authorised
| API unavailability | 2023/12/20 | 2024/04/15 | | 2024/02/02 |
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 | Awaiting update from the company |
| 2024/04/25 |
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 | 2024/04/30 | | 2023/11/21 |
Ondansetron 2mg/ml Solution for Injection
(4ml ampoule)
PA1122/004/001
Noridem Enterprises Limited
| Ondansetron
| Similar alternative medicine auhtorised
| Unexpected increase in demand | 2023/11/13 | 2024/03/19 | | 2024/03/14 |
Ondansetron 8mg Film Coated Tablets
PA0749/009/002
Teva Pharma B.V. | Ondansetron | Similar alternative medicine authorised | Awaiting update from the company | 2024/02/28 | 2024/05/08 | | 2024/02/19 |
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 delays | 2021/11/01 | Unknown at present |
| 2022/11/21 |
Paclitaxel 6mg/ml Concentrate for Solution for Infusion
50ml presentation
PA2315/180/001
Accord Healthcare Ireland Ltd. | Paclitaxel | Similar alternative medicine authorised | Manufacturing delay | 2024/02/28 | 2024/06/30 | | 2024/04/25 |
Palonosetron 250 micrograms Solution for Injection
PA2059/014/001
Fresenius Kabi Deutschland GmbH
| Palonosetron | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted) | 2024/03/04 | Awaiting update from the company | | 2024/04/22 |
Palonosetron 250 micrograms Solution for Injection in pre-filled syringe
PA2059/014/002
Fresenius Kabi Deutschland GmbH
| Palonosetron | Similar alternative medicine authorised | Manufacturing delay
(multiple countries impacted)
| 2024/03/04 | 2024/04/15 | | 2024/03/26 |
Pantup Relief 20mg Gastro-Resistant Tablets
PA0711/142/003
Rowex Ltd
| Pantoprazole
| Similar alternative medicine authorised
| Unexpected increase in demand | 2023/03/27 | 2024/06/30 |
| 2023/10/05 |
Paricalcitol 5 micrograms/ml solution for injection
PA0281/163/001
Pinewood Laboratories Ltd
| Paricalcitol | Similar alternative medicine authorised
| Manufacturing delay | 28/02/2024 | Unknown at present | | 2024/03/08 |
Pioglitazone Accord 45mg Tablets
EU/1/11/722/022
Accord Healthcare Ireland Ltd. | Pioglitazone
| Similar alternative medicine authorised | Awaiting information | 2024/05/15 | Awaiting information | | 2024/05/09 |
Ponstan Forte 500mg Film Coated Tablets
PA22643/001/002
Chemidex Pharma Limited
| Mefenamic acid
| Similar alternative medicine authorised
| Manufacturing delay | 2023/10/30 | 2024/05/31
|
| 2024/04/10 |
Ponstan 250mg Capsules
PA22643/001/001
Chemidex Pharma Limited
| Mefenamic acid
| Similar alternative medicine authorised | Manufacturing delay | 2023/10/30 | 2024/05/31 | | 2024/04/10 |
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 |
Propess 10mg vaginal delivery system
PA1009/029/001
Ferring Ireland Ltd
| Dinoprostone
| Comparable alternative medicine authorised | Manufacturing delay | 2024/05/01 | 2024/06/15 | HCP letter | 2024/05/01 |
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 | 2024/05/15 | | 2024/02/27 |
Quetiapine 25mg film-coated tablets
PA2315/117/001
Accord Healthcare Ireland Ltd | Quetiapine
| Similar alternative medicine authorised | Manufacturing delay | 2024/04/30 | 2024/07/01 | | 2024/05/09 |
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 | 2024/07/31 | | 2023/08/24 |
Rasagiline Accord 1mg Tablets
PA2315/174/001
Accord Healthcare Ireland Ltd
| Rasagiline | Similar alternative medicine authorised | Unexpected increase in demand | 2024/04/30 | 2024/07/31 | | 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 |
Rasagiline Rowex 1mg tablets
PA0711/264/001
Rowex Ltd.
| Rasagiline
| Similar alternative medicine authorised
| Unexpected increase in demand
(multiple counties affected)
| 2023/08/12 | 2024/12/15 | | 2024/05/07 |
| 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 | | 2024/03/08 |
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 | 2024/05/12 | | 2024/04/24 |
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 |
Risonate Once Weekly 35mg Film Coated Tablets
PA0749/064/001
Teva Pharma B.V.
| Risedronate
| Similar alternative medicine authorised
| API unavailability
(multiple countries affected) | 2022/06/27 | Awaiting update from the company
|
| 2024/02/14 |
Ritalin LA 20mg prolonged-release capsules
PA1972/002/002
InfectoPharm Arzneimittel und Consilium GmbH
| Methylphenidate | Similar alternative medicine authorised | Manufacturing delay | 2024/05/06 | 2024/06/03 | | 2024/05/09 |
Ritalin LA 40mg prolonged-release capsules
PA1972/002/004
InfectoPharm Arzneimittel und Consilium GmbH
| Methylphenidate
| Similar alternative medicine authorised | Manufacturing delay | 2024/05/13 | 2024/06/24 | | 2024/04/29 |
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 |
Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray, suspension
PA1543/002/001
Glenmark Pharmaceuticals s.r.o.
| Mometasone & olopatadine
| Comparable alternative medicine authorised
| Manufacturing delay
(multiple countries impacted)
| 2024/04/12 | 2024/05/15 | | 2024/04/12 |
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 | 2024/05/31 | | 2024/02/26
|
Sastravi 125mg/31.25mg/200mg Film-coated Tablets
PA0549/026/002
Teva B.V.
| Levodopa, carbidopa
& entacapone
| Appropriate alternative medicine authorised
| Manufacturing delay
(multiple countries impacted)
| 2024/02/03 | 2024/04/15 | | 2024/04/12 |
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 | Awaiting update from the company
| | 2024/03/21 |
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 | | 2024/02/29 |
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 |
| 2024/04/11 |
Stemetil 12.5 mg/ml solution for injection - 1 ml Ampoule
PA0540/127/002
Sanofi-Aventis Ireland Limited T/A SANOFI
| Prochlorperazine
| Comparable alternative medicine authorised | Regulatory issue
(multiple countries impacted) | 2024/04/01 | 2024/05/17 | | 2024/04/03 |
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 | 2024/04/26 | | 2024/04/10 |
Suprax 200 mg Film-coated Tablets
PA1142/042/001
Amdipharm Limited
| CEFIXIME
| Appropriate alternative medicine authorised
| Manufacturing delay | 2024/03/04 | 2024/05/31 | | 2024/05/03 |
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 | 2024/05/31 | | 2024/04/24 |
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 | 2024/05/31 | | 2024/03/11 |
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 80 mg tablets
PA0074/078/003
Rowa Pharmaceuticals Limited
|
Telmisartan | Similar alternative medicine authorised
| Unexpected increase in demand
| 2024/01/29 | 2024/06/30
| | 2024/05/07 |
Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets
PA2315/107/003
Accord Healthcare Ireland Ltd.
| Telmisartan & hydrochlorothiazide | Similar alternative medicine authorised
| Unexpected increase in demand | 2023/10/09 | 2024/07/31 | | 2024/03/21 |
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 | 2024/04/21 | | 2024/02/20 |
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 | 2024/05/20 | | 2024/02/27 |
Testogel 50mg transdermal gel in sachet
PA1054/002/002
Laboratoires Besins International
| Testosterone | Similar alternative medicine authorised
| Manufacturing delay | 2024/02/19 | 2024/04/15 | | 2024/02/06 |
TEVETEN 400 mg, film-coated tablets
PA2010/017/001
Mylan IRE Healthcare Limited
| Eprosartan
| Appropriate alternative medicine authorised
| Manufacturing delay | 2024/02/26 | 2024/06/16 | | 2024/02/28 |
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 | 2024/08/31 | HCP letter | 2024/04/11 |
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 | 2024/05/25 | | 2024/02/20 |
Toviaz 4mg Prolonged Release Tablets
EU/1/07/386/003
Pfizer Europe MA EEIG
| Fesoterodine
| Similar alternative medicine authorised
| Quality issue | 2023/07/03 | Awaiting update from the company |
| 2024/03/11 |
Toviaz 8 mg Prolonged-release tablet
EU/1/07/386/008
Pfizer Europe MA EEIG
| Fesoterodine
| Similar alternative medicine authorised
| Quality issue
(multiple countries affected) | 2023/10/16 | Awaiting update from the company | | 2024/03/11 |
Trandate 200mg Film-coated Tablets
PA1638/006/003
RPH Pharmaceuticals AB
| Labetalol
| Similar alternative medicine authorised
| Manufacturing delay
(multiple countries affected)
| 2024/03/15 | 2024/04/30 | | 2024/03/01 |
Tyvense 60mg Capsules
PA23211/005/005
Takeda Pharmaceuticals International AG Ireland Branch
|
Lisdexamfetamine
| Similar alternative medicine authorised | Manufacturing delays
(multiple countries impacted) | 2024/04/29 | 2024/06/16 | | 2024/04/29 |
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 | 2024/05/24 | | 2024/05/01 |
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 | 2024/05/24 | | 2024/05/01 |
Valcyte 50 mg/ml powder for oral solution
PA2239/023/002
CHEPLAPHARM Arzneimittel GmbH
| Valganciclovir
| Appropriate alternative medicine authorised
| Unexpected increase in demand | 2024/01/18 | 2024/03/28 | | 2024/03/11 |
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 | 2024/04/30
| | 2024/03/21
|
Vancomycin 500mg Powder for Concentrate for Solution for Infusion and Oral Solution
PA1122/008/001
Noridem Enterprises Limited
| Vancomycin | Similar alternative medicine authorised | Unexpected increase in demand | 2024/03/03 | Awaiting update from the company | | 2024/02/27 |
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 | Awaiting update from the company | | 2024/03/11
|
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 | 2024/07/15 | | 2024/05/07 |
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 | Unknown at present | | 2023/11/09 |
Zaditen 1mg/5ml oral solution
PA2206/004/001
Alfasigma S.p.A
| Ketotifen | Appropriate alternative medicine authorised
| Manufacturing delay | 2024/01/01 | 2024/03/15 | | 2023/12/22 |
Zestan 2.5mg Tablets
PA0126/112/001
Clonmel Healthcare Ltd | Lisinopril
| Appropriate alternative medicine authorised | Quality issue | 2024/04/08 | Awaiting update from the company | | 2024/04/22 |
Zestan 5mg Tablets
PA0126/112/002
Clonmel Healthcare Ltd | Lisinopril
| Appropriate alternative medicine authorised
| Quality issue | 2024/01/13 | Awaiting update from the company
| | 2024/04/22 |
Zestan 10mg Tablets
PA0126/112/003
Clonmel Healthcare Ltd | Lisinopril
| Appropriate alternative medicine authorised
| Quality issue | 2024/04/04 | Awaiting update from the company
| | 2024/04/22 |
Zestan 20mg Tablets
PA0126/112/004
Clonmel Healthcare Ltd | Lisinopril
| Appropriate alternative medicine authorised
| Quality issue | 2024/04/08 | Awaiting update from the company
| | 2024/04/22 |
Zindaclin 1% Gel
PA23139/001/001
Canute Pharma (Ireland) Limited
| Clindamycin
| Similar alternative medicine authorised
| Distribution issue | 2022/12/01 | 2024/12/31 |
| 2024/02/14 |
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 |
| 2024/04/25 |
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 | | 2025/04/25 |
Zofran 4mg/5ml Syrup
PA0711/327/002
Rowex Ltd
| Ondansetron
| Appropriate alternative medicine authorised
| Manufacturing delay
| 2022/12/15 | 2024/06/30 | | 2024/04/25 |
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 | 2024/05/10 | | 2024/05/09 |