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
22/05/2006 Revatio (sildenafil citrate) - Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
12/05/2006 Seroxat (paroxetine hydrochloride) - Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
02/05/2006 Zyvox (linezolid) - Important Safety Information received from Pfizer as approved by the Irish Medicines Board 3rd Party Publications
30/04/2006 CLEXANE (enoxaparin) 3rd Party Publications
31/03/2006 BCG VACCINE SSI 31.03.2006 3rd Party Publications
09/02/2006 Urgent Batch Recall of Clexane Syringes (Enoxaparin Sodium Ph. Eur.) 80mg/0.8ml Recall
31/01/2006 FENTANYL PATCHES 3rd Party Publications
31/12/2005 NSAIDs 3rd Party Publications
30/11/2005 Antidepressant Medication for Children 3rd Party Publications
17/11/2005 Safety Notice - Concerning Two Traditional Chinese Medicinal Products which contain High Levels of Mercury Advisory