My HPRA: Register

Medicinal Product Shortages

Update on Supply of Adrenaline Auto-Injectors – 12 December 2018

The HPRA is aware of the global intermittent supply of adrenaline auto-injectors (AAIs) that impacts the Irish market. We have been working closely with all suppliers of AAIs to reduce the impact of supply disruptions on patients and healthcare professionals. While there are limited supplies of some specific AAIs, alternative AAIs are available.

The HPRA advises that patients and their carers familiarise themselves with the AAI that has been supplied as it may not have been one you have received previously. If you have any questions relating to administration of the auto-injector, please speak to your pharmacist or doctor.

The HPRA will be maintaining regular contact with all AAI suppliers and other relevant stakeholders. The medicine shortages list will be updated frequently as new information arrives and will provide information in relation to shortages of any individual medicines.

 

Medicinal Product Shortages

The HPRA is responsible for co-ordinating the management of shortages of medicines on the Irish market. The HPRA works with a variety of stakeholders including manufacturers, wholesale distributors, marketing authorisation holders, healthcare professionals, the Health Service Executive, patients and representative groups to respond to potential shortages and reduce the impact of shortages on patients.

The definition of a shortage is when the supply of a medicinal product is inadequate to meet the needs of the patient. 

The HPRA, in collaboration with stakeholders, has published a framework for a multi-stakeholder approach to handling shortages of human medicinal products. The aim of the framework is to help prevent shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise.
 

Reports of shortages

The HPRA welcomes and encourages reports of medicinal products shortages from all stakeholders.

Marketing Authorisation Holders:

Please complete the Notification of medicinal product shortage from marketing authorisation holder form and return to shortages@hpra.ie and to the HSE Corporate Pharmaceutical Unit.

Wholesale Distributors and Manufacturers:

Please complete the Report of Medicinal Products Shortages from Wholesale Distributors and Manufacturers form and return this form to shortages@hpra.ie.

Patients and Healthcare Professionals:

Please complete the Report of a Medicinal Product Shortage from Patients and Healthcare Professionals form and return to shortages@hpra.ie. When completing this form, please include as much information as possible.

Current and resolved shortages

The HPRA publishes a list of shortages currently affecting the Irish market that have been notified to us and that may have a medium or high impact on patients. This list can be found below. More information on the impact level can be found in the framework for a multi-stakeholder approach to handling shortages of human medicinal products.

The HPRA maintains a consolidated list of resolved shortages for a period of six months. Details of shortages that have been resolved in the last six months can be found here.

 

Product name


Authorisation number		 Active ingredient Reason for shortage Date of shortage


Expected return date 		Additional information
Accupro 40mg Film Coated Tablet 

PA0822/007/004 		 Quinapril hydrochloride  Manufacturing delays  Date of shortage:
End of November 2018

Expected return date:
Mid February 2019 		 Last updated:
12th December 2018
Adalat LA 20mg Prolonged Release Tablet

PA1410/025/005		 Nifedipine  Manufacturing delays

(multiple countries affected)		 Date of shortage:
November 2017
 
Expected return date:
End of May 2019		 Last updated:
4th September 2018

MAH press release
Adalat LA 30mg Prolonged Release Tablet

PA1410/025/006		 Nifedipine  Manufacturing delays

(multiple countries affected)		 Date of shortage:
24th June 2018

Expected return date:
End of January 2019		 Last updated:
4th September 2018

MAH press release
Adalat LA 60mg Prolonged Release Tablet

PA1410/025/007 		  Nifedipine Manufacturing delays

(multiple countries affected)		 Date of shortage:
September 2018

Expected return date:
End May 2019		 Last updated:
4th September 2018

MAH press release
Anapen Junior 0.15mg Solution for Injection

PA1072/001/001 		 Adrenaline  Unexpected increase in demand  Date of shortage:
Mid November 2018

Expected return date:
Mid December 2018		 Last updated:
21st November 2018
Bupivacaine hydrochloride 0.5% w/v Solution for Injection

PA0073/091/002 		 Bupivacaine hydrochloride  Unexpected increase in demand  Date of shortage:
24th  November 2018

Expected return date:
21st December 2018 		 Last updated:
6th December 2018
Caverject 10mcg Powder for Solution for Injections

PA0822/115/002 		 Alprostadil  Manufacturing delays

(multiple countries affected) 		 Date of shortage:
January 2019

Expected return date:
End of March 2019 		 Last updated:
28th November 2018 
Caverject 20mcg Powder for Solution for Injection 

PA0822/115/003		 Alprostadil  Manufacturing delays 

(multiple countries affected)		 Date of shortage:
5th October 2018

Expected return date:
Mid January 2019
 Last updated:
19th October 2018

HCP Letter
Co-Vatan 80mg/12.5mg Film Coated Tablet

PA0711/182/001 		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected date of return:
Mid December 2018		 Last updated: 
4th September 2018
Co-Vatan 160mg/12.5mg Film Coated Tablet

PA0711/182/002  		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
Mid December 2018 		 Last updated:
4th September 2018
Co-Vatan 160mg/25mg Film Coated Tablet 

PA0711/182/003		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
Mid December 2018		 Last updated:
4th September 2018 
Cyklokapron 500mg Tablets

PA1332/003/001 		  Tranexamic acid Manufacturing delays

(multiple countries affected) 		 Date of shortage:
1st December 2018

Expected return date:
Q2 2019 		 Last updated:
4th December 2018
Doxatan 1mg Tablet

PA0126/202/001 		 Doxazosin  Manufacturing delays  Date of shortage:
End of October 2018

Expected return date:
January 2019		 Last updated:
7th November 2018
Emerade 150mcg Solution for Injection in Pre Filled Pen

PA1696/009/001		 Adrenaline  Unexpected increase in demand  Date of shortage:
Early December 2018

Expected return date:
17th December 2018		 Last updated:
6th December 2018
Emerade 300mcg Solution for Injection in Pre Filled Pen

PA1696/009/002 		 Adrenaline  Unexpected increase in demand  Date of shortage:
Early December 2018

Expected return date:
17th December 2018 		 Last updated:
6th December 2018
EpiPen Junior 150mcg Solution for injection in pre filled pen

PA1332/050/001  		 Adrenaline  Manufacturing delays

(multiple countries affected) 		 Date of shortage:
November 2018

Expected return date:
End of December 2018
 Last updated:
5th December 2018
Erwinase 10000% v/v Powder for Solution for Injection

PA1020/002/001  		  Cristanspase Manufacturing delays

(multiple countries affected)		 Date of shortage:
5th October 2018

Expected return date:
January 2019
 Last updated:
26th November 2018

HCP Letter
 
Fluorouracil 25mg/ml Solution for Injection or Infusion

PA0822/223/001 		 Fluorouracil sodium  Manufacturing delays  Date of shortage:
28th September 2018

Expected return date:
End of January 2019		 Last updated:
16th November 2018
 
Glucose IV Infusion BP 10% w/v Solution for Infusion

PA0179/001/028 		 Anhydrous Glucose  Manufacturing delays  Date of shortage:
20th November 2018

Expected return date:
Mid December 2018		 Last updated:
30th November 2018
Hydrocortone 10mg Tablets

PA1986/054/001 		 Hydrocortisone  Manufacturing delays  Date of shortage:
November 2018

Expected return date:
Start of January 2019 		 Last updated:
29th November 2018

HCP Letter
Instanyl 50mcg Single Dose Nasal Spray

EU/1/09/531/010-013 		  Fentanyl Manufacturing delays 

(multiple countries affected) 		 Date of shortage:
17th August 2018

Expected return date:
January 2019		 Last updated: 
4th December 2018
Jext 150mcg Solution for Injection in a Pre Filled Pen

PA1255/006/001 		  Adrenaline Unexpected increase in demand 

(multiple countries affected)		 Date of shortage:
5th December 2018

Expected return date:
21st December 2018		 Last updated:
6th December 2018 
Jext 300mcg Solution for Injection in a Pre Filled Pen

PA1255/006/002 		  Adrenaline Unexpected increase in demand

(multiple countries affected) 		 Date of shortage:
5th December 2018

Expected return date:
21st December 2018 		 Last updated:
6th December 2018
Lopid 300mg Capsules - 100 pack size

PA0822/014/001 		 Gemfibrozil  Manufacturing delays  Date of shortage:
Mid November 2018 

Expected return date:
Early December 2018		 Last updated:
16th November 2018 
Marcain Polyamp Steripack 0.25% w/v Solution for Injection
 

PA1691/024/001		 Bupivacaine hydrochloride Manufacturing delays

(multiple countries affected)		 Date of shortage:
14th February 2018
 
Expected return date:
End of October 2019 		 Last updated:
4th September 2018
 
 HCP Letter
Marcain Polyamp Steripack 0.5% w/v Solution for Injection

PA1691/024/002		 Bupivacaine hydrochloride Manufacturing delays

(multiple countries affected)		 Date of shortage:
12th November 2017
 
Expected return date:
End of October 2019
 		 Last updated:
4th September 2018
 
HCP Letter
Naltrexone Hydrochloride 50mg Film Coated Tablet

PA1390/020/001 		 Naltrexone hydrochloride Unexpected increase in demand Date of shortage:
End of November 2018

Expected return date:
Mid December 2018		 Last updated:
5th December 2018
Naropin 2mg/ml Solution for Injection

PA1691/026/001		 Ropivacaine hydrochloride Manufacturing delays

(multiple countries affected)		 Date of shortage:
October 2017
 
Expected return date:
End of October 2019
 		 Last updated:
4th September 2018
 
HCP Letter
Naropin 7.5mg/ml Solution for Injection

PA1691/026/002 		 Ropivacaine hydrochloride Manufacturing delays

(multiple countries affected)		 Date of shortage:
25th September 2017

Expected return date:
End of October 2019		 Last updated:
4th September 2018
 
HCP Letter
Palonosetron Accord 250mcg Solution for Injection

EU/1/16/1104/001 		 Palonosetron hydrochloride  Manufacturing delays  Date of shortage:
Mid November 2018

Expected return date:
End of January 2018		 Last updated:
23rd October 2018 
Parnate 10mg Coated Tablet

PA0899/016/001 		 Tranylcypromine sulphate  Manufacturing delays  Date of shortage:
9th November 2018

Expected return date:
January 2019		 Last updated:
16th November 2018

HCP Letter
Piperacillin with Tazobactam 2.25g Powder for Solution for Injection

PA1339/001/001 		 Piperacillin sodium & Tazobactam sodium Manufacturing delays

(multiple countries affected)		 Date of shortage:
January 2018

Expected return date:
Unknown 		Last updated: 4th September 2018
Piperacillin with Tazobactam 4.5g Powder for Solution for Injection

PA1339/001/002 		 Piperacillin sodium & Tazobactam sodium Manufacturing delays

(multiple countries affected)		 Date of shortage:
January 2018

Expected return date:
Unknown		 Last updated:
4th September 2018
Pred Forte 1% w/v Eye Drop Suspension

PA0148/027/001 		 Prednisolone acetate  Manufacturing delays

(multiple countries affected)		 Date of shortage:
August 2018

Expected return date:
End of March 2019 		 Last updated:
14th December 2018 
Quinine Sulphate 300mg Coated Tablet

PA1986/052/001 		 Quinine Sulphate  Manufacturing delays  Date of shortage:
Early November 2018

Expected return date:
5th December 2018 		 Last updated:
28th November 2018 
Sastravi 100/25/200mg Film Coated Tablet

PA1380/154/003 		 Levodopa, Carbidopa & Entacapone Manufacturing delays Date of shortage:
October 2018

Expected return date:
18th December 2018		 Last updated:
29th November 2018
Septrin 480mg per ampule Solution for Infusion

PA1691/010/005 		 Trimethoprim and Sulfamethoxazole Manufacturing delays

(multiple countries affected)		 Date of shortage:
27th October 2018

Expected return date:
Mid March 2019
 		 Last updated:
6th December 2018
             
HCP Letter
Simvastatin 10mg Film Coated Tablets

PA0749/052/002 		 Simvastatin  Manufacturing delays  Date of shortage:
October 2018

Expected return date:
Mid January 2019		 Last updated:
29th November
2018 
Sinemet 25/250mg 100 Tabs Tablets

PA1286/009/005		 Carbidopa & Levodopa Manufacturing delays

(multiple countries affected) 		 Date of shortage:
October 2018

Expected return date:
Before end of March 2019 		 Last updated: 14th September 2018

HCP Letter
Sinemet Plus 25/100mg 100 Tabs

PA1286/009/004		 Carbidopa & Levodopa Manufacturing delays

(multiple countries affected)		 Date of shortage:
October 2018

Expected return date:
Before end of March 2019		 Last updated:
14th September 2018

HCP Letter
Stesolid 10mg Rectal Solution

PA1390/141/002 		 Diazepam  Unexpected increase in demand  Date of shortage:
End of November 2018

Expected return date:
Awaiting update 		 Last updated:
12th December 2018
Tadalafil Krka 10mg Film Coated Tablet

PA1347/071/003 		 Tadalafil Unexpected increase in demand  Date of shortage:
October 2018

Expected return date:
18th December 2018 		 Last updated:
29th November 2018 
Trimoptin 100mg Tablets

PA0298/014/001 		  Trimethoprim Manufacturing delays  Date of shortage:
Early October 2018

Expected return date:
End January 2019		 Last updated:
9th October 2018
Trimoptin 200mg Tablets

PA0298/014/002 		 Trimethoprim  Manufacturing delays  Date of shortage:
Early October 2018

Expected return date:
End January 2019 		 Last updated:
9th October 2018
Valsartan Actavis 40mg Film Coated Tablet 

PA1380/022/001		 Valsartan Active substance impurity

(multiple countries affected)
                        		 Date of shortage:
July 2018

Expected return date:
End of January 2019		 Last updated: 
4th September 2018
Valsartan Actavis 80mg Film Coated Tablet

PA1380/022/002
     		 Valsartan Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
End of January 2019		 Last updated:
4th September 2018
Valsartan Actavis 160mg Film Coated Tablet 

PA1380/022/003		 Valsartan Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
End of January 2019
 		 Last updated:
4th September 2018
Valsartan Mylan 40mg Film Coated Tablet

PA0577/134/001 		 Valsartan  Unexpected increase in demand  Date of shortage:
Awaiting update
 
Expected return date:
Mid December 2018		 Last updated:
19th November 2018 
Valsartan Mylan 80mg Film Coated Tablet

PA0577/134/002 		 Valsartan  Unexpected increase in demand  Date of shortage:
Early November 2018

Expected return date:
Mid December 2018		 Last updated:
19th November 2018 
Valsartan Mylan 320mg Film Coated Tablet 

PA0577/134/004		 Valsartan  Unexpected increase in demand  Date of shortage:
Early November 2018

Expected return date:
Mid December 2018		 Last updated:
19th November 2018 
Valsartan Teva 40mg Film Coated Tablet

PA0749/084/001 		  Valsartan Unexpected increase in demand

(multiple countries affected) 		 Date of shortage: 
July 2018

Expected return date:
Unknown at present		 Last updated:
4th October 2018
Valsartan Teva 80mg Film Coated Tablet

PA0749/084/002 		  Valsartan Unexpected increase in demand

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
Unknown at present		 Last updated:
4th October 2018
Valsartan / Hydrochloride 80mg/12.5mg Film Coated Tablet

PA1380/101/001		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
End of January 2019		 Last updated: 4th September 2018
Valsartan / Hydrochlorothiazide 160mg/12.5mg Film Coated Tablet 

PA1380/101/002		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
End of January 2018		 Last updated: 4th September 2018
Valsartan / Hydrochlorothiazide 160mgmg/ 25mg Film Coated Tablet

PA1380/101/003 		 Valsartan & Hydrochlorothiazide Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
End of January 2019		 Last updated: 4th September 2018
Valtan 40mg Film Coated Tablet 

PA0126/211/001 		  Valsartan Unexpected increase in demand Date of shortage:
24th October 2018

Expected return date:
Awaiting update		 Last updated:
3rd December 2018
Valtan 80mg Film Coated Tablet

PA0126/211/002 		 Valsartan  Unexpected increase in demand Date of shortage:
26th September 2018
 
Expected return date:
Unknown at present
 Last updated:
5th October 2018
Valtan 160mg Film Coated Tablet

PA0126/211/003		 Valsartan  Unexpected increase in demand  Date of shortage:
24th October 2018

Expected return date:
February 2019		 Last updated:
5th October 2018
Vatan 40mg Film Coated Tablet

PA0711/183/001		 Valsartan  Active substance impurity

(multiple countries affected) 		 Date of shortage:
July 2018

Expected return date:
Mid December 2018		 Last updated:
18th October 2018 
Vatan 80mg Film Coated Tablets

PA0711/183/002 		 Valsartan  Active Substance Impurity

(multiple countries affected) 		 Date of shortage:
July 2018

Expected return date:
Mid December 2018		 Last updated:
18th October 2018
Vatan 160mg Film Coated Tablets

PA0711/183/003 		 Valsartan Active Substance impurity

(multiple countries affected) 		  
Date of shortage:
July 2018

Expected return date:
Mid December 2018		 Last updated:
18th October 2018

Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL
Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL
Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL


Contact us:

Medicinal Product Shortages Unit
Health Products Regulatory Authority 
Kevin O’Malley House
Earlsfort Terrace,
Dublin 2
Tel: +353 1 676 4971
Fax: +353 1 676 7836
shortages@hpra.ie