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
13/01/2017 HPRA MIMS Article January 2017 Otezla (apremilast) - Important advice regarding suicidal ideation and behaviour 3rd Party Publications
06/01/2017 Braltus (tiotropium) - Important Safety Information from Teva Pharmaceuticals Ireland as approved by the HPRA 3rd Party Publications
19/12/2016 HPRA MIMS Article November 2016 Fingolimod (Gilenya) - Risks related to immunosuppressive effects 3rd Party Publications
19/12/2016 Ammonaps (sodium phenylbutyrate) - Important Safety Information from Swedish Orphan Biovitrum International AB (Sobi), as approved by the HPRA 3rd Party Publications
13/12/2016 Product Information Update- Levonorgestrel emergency contraception (Levonorgestrel). HPRA notice 2016 3rd Party Publications
01/12/2016 Product Information Update- Levonorgestrel-containing emergency hormonal contraception (Levonorgestrel) 3rd Party Publications
25/11/2016 Keppra (levetiracetam) - Important Safety Information from UCB (Pharma) Ireland Limited as approved by the HPRA 3rd Party Publications
15/11/2016 Product Information Update- Innohep 20,000 IU/ml vial and syringes (tinzaparin sodium) 3rd Party Publications
08/11/2016 Revlimid (lenalidomide) - Important Safety Information from Celgene Europe Limited as approved by the HPRA (Nov 2016) 3rd Party Publications
08/11/2016 Otezla (apremilast) - Important Safety Information from Celgene Europe Limited as approved by the HPRA 3rd Party Publications