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
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
15/05/2013 Protelos (strontium ranelate) Important Safety Information from Servier as approved by the Irish Medicines Board 3rd Party Publications
07/05/2013 Increlex (mecasermin) Important Safety Information from Ipsen as approved by the Irish Medicines Board 3rd Party Publications
03/05/2013 Fastum Gel (ketoprofen) Important Safety Information from A. Menarini as approved by the Irish Medicines Board 3rd Party Publications