Safety Notices

From time to time notices relating to the safety, efficacy and quality of human medicinal products are published by the Health Products Regulatory Authority.

The issues covered by these notices include medicinal product safety information, updated efficacy information on the appropriate usage of medicines and quality defect information.

Notices are categorised in accordance with their importance at time of publication.

The four notice categories are outlined as follows:

  • Advisory  -  Routine safety information            
  • Warning  -  Urgent safety information
  • Recall  -  Urgent safety information relating to a product recall
  • Publications  -  General information provided by 3rd parties as approved by the HPRA, e.g. MIMS, Direct Healthcare Professional Letter or Product Information Update

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
12/07/2021 Xeljanz (tofacitinib) - Important Safety Information from Pfizer Healthcare Ireland as approved by the HPRA (July 2021) 3rd Party Publications
25/06/2021 DINOPROSTONE - Important Safety Information from Ferring Ireland Limited and Pfizer Healthcare Ireland of products containing Dinoprostone as approved by the HPRA 3rd Party Publications
22/06/2021 VAXZEVRIA - COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA 3rd Party Publications
11/06/2021 Venclyxto (venetoclax) film coated tablets - Important Safety Information from AbbVie Limited as approved by the HPRA 3rd Party Publications
08/06/2021 Product Information Update – Chloromycetin Redidrops Eye Drops (Chloramphenicol) 3rd Party Publications
01/06/2021 VAXZEVRIA/COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA - Updated Information 3rd Party Publications
10/05/2021 Product Information Update — Madopar 3rd Party Publications
27/04/2021 Covid-19 Vaccine Janssen - Important Safety Information from Janssen Sciences Ireland UC as approved by the HPRA 3rd Party Publications
16/04/2021 EYLEA 40 mg/mL (aflibercept solution for intravitreal injection) - Important Safety Information from Bayer Ltd as approved by the HPRA 3rd Party Publications
14/04/2021 VAXZEVRIA/COVID-19 Vaccine AstraZeneca - Important Safety Information from AstraZeneca Pharmaceuticals (Ireland) DAC as approved by the HPRA 3rd Party Publications