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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.

 

Update on Supply of Adrenaline Auto-Injectors 

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.

Product name


Authorisation number		 Active ingredient Reason for shortage Date of shortage


Expected return date 		Additional information
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
Amikin 100mg/2ml Solution for Injection

PA2255/001/001 		 Amikacin sulphate  Unexpected increase in demand  Date of shortage:
Mid October 2018

Expected return date:
Early November 2018 		 Last updated:
16th October 2018
Anapen Junior 0.15mg Solution for Injection

PA1072/001/001 		 Epinephrine  Unexpected increase in demand  Date of shortage:
5th October 2018

Expected return date:
December 2018		 Last updated:
9th October 2018
Ativan 4mg/ml Solution for Injection

PA0822/090/002		 Lorazepam  Manufacturing delays

(multiple countries affected)		 Date of shortage:
12th September 2018

Expected return date:
Early November 2018		 Last updated: 
1st October 2018

HCP Letter
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:
December 2018		 Last updated:
8th 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 
Diovan 80mg Film Coated Tablet

PA0896/009/001		 Valsartan Unexpected increase in demand  Date of shortage:
1st October 2018

Expected return date:
19th October 2018
 Last updated:
5th October 2018
Diovan 160mg Film Coated Tablet

PA0896/009/002		 Valsartan  Unexpected increase in demand Date of shortage:
10th October 2018

Expected return date:
2nd November 2018		 Last updated:
5th October 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:
End of November 2018		 Last updated:
15th October 2018

HCP Letter
Fludrocortisone Acetate 0.1mg Tablets

PA1691/018/001 		 Fludrocortisone acetate Manufacturing delays Date of shortage:
18th September 2018

Expected return date:
26th October 2018		 Last updated:
9th October 2018
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 November 2018		 Last updated:
17th October 2018

HCP Letter
Imuran 50mg Powder for Solution for Injection/Infusion


PA1691/003/001		 Azathioprine sodium Manufacturing delays

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


Expected return date: 
1st December 2018		 Last updated: 
17th October 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:
End of November 2018		 Last updated: 4th September 2018
Jext 150mcg Solution for Injection in Pre-filled Pen

PA1255/006/001		  Epinephrine Unexpected increase in demand  Date of shortage:
4th October 2018

Expected return date:
Early November 2018 		 Last updated:
9th October 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
Morphine Sulphate 10mg/ml Solution for Injection

PA0073/020/001 		 Morphine Sulphate Manufacturing delays Date of shortage:
21st September 2018

Expected return date:
23rd October 2018		 Last updated:
16th October 2018
Naropin 2mg/ml Solution for Injection

PA1691/026/001		 Ropivacaine hydrochloride Manufacturing delays

(multiple countries affected)		 Date of shortage:
25th 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
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
Septrin 480mg per ampule Solution for Infusion

PA1691/010/005 		 Trimethoprim and Sulfamethoxazole Manufacturing delays

(multiple countries affected)		 Date of shortage:
3rd October 2018

Expected return date:
End of January 2019
 		 Last updated:
4th September 2018
 
HCP Letter
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:
13th September 2018

Expected return date:
Mid - December 2018		 Last updated:
17th September 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 Krka 160mg Film Coated Tablet

PA1347/010/008 		 Valsartan  Unexpected increase in demand Date of shortage:
September 2018
 
Expected return date:
End of October 2018		 Last updated:
4th October 2018
Valsartan Rowa 40mg Film Coated Tablet

PA0074/083/001 		  Valsartan Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected date of return:
Mid December 2018		 Last updated:
4th September 2018
Valsartan Rowa 80mg Film Coated Tablet

PA0074/083/002 		  Valsartan Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected date of return:
Mid December 2018		 Last updated:
4th September 2018
Valsartan Rowa 160mg Film Coated Tablet

PA0074/083/003 		  Valsartan Active substance impurity

(multiple countries affected)		 Date of shortage:
July 2018

Expected return date:
Mid December 2018		 Last updated: 4th September 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:
End of November 2018		 Last updated:
5th October 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

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