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
25/06/2013 Trobalt (retigabine) Important Safety Information from GlaxoSmithKline as approved by the Irish Medicines Board 3rd Party Publications
21/06/2013 Dianette (cyproterone acetate 2mg/ethinylestradiol 35 mcg) Important Safety Information from Bayer Ltd. as approved by the Irish Medicines Board 3rd Party Publications
21/06/2013 Sublimaze 50 micrograms/ml Solution for Injection Important Safety Information from Janssen as approved by the Irish Medicines Board 3rd Party Publications
14/06/2013 Questran- Important information from BMS on precautionary pharmacy level recall, as approved by the Irish Medicines Board 3rd Party Publications
14/06/2013 PRAC recommends restricting the use of codeine when used for pain relief in children 3rd Party Publications
14/06/2013 PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch 3rd Party Publications
14/06/2013 PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors 3rd Party Publications
17/05/2013 European Medicines Agency (EMA) announces benefits of Diane 35 and generics outweigh risks in specific patient group 3rd Party Publications
17/05/2013 Avastin (bevacizumab) Important Safety Information from Roche as approved by the Irish Medicines Board 3rd Party Publications
17/05/2013 Synacthen (tetracosactide) Important Safety Information from SOBI AB as approved by the Irish Medicines Board 3rd Party Publications