Recall | Medicines | 22/01/2013
The marketing authorization holder has informed its supplied customers that preliminary results from the HPS2-THRIVE study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) failed to show any additional benefit of…
Replacement | Medicines | 20/12/2012
The marketing authorization holder informed its supplied customers in a letter dated Dec. 20, 2012, that the batch would be replaced due to unusual discoloration after reconstitution.
Recall | Veterinary Medicines | 19/12/2012
B. Braun Austria Ges.m.b.H. has informed its supplied customers by letter dated December 17, 2012, that precipitations were observed during the examination of reserve samples of the above mentioned batch and therefore a recall will be carried out.…
Replacement | Medicines | 19/12/2012
The distributor has informed its supplied customers that the above batch was intended for Germany or was placed on the market in Austria in German presentation and thus an exchange for Austrian goods will be carried out.
Recall | Medicines | 04/12/2012
In a letter dated November 29, 2012, the marketing authorization holder informed the physicians concerned that the shelf life of the physician samples with the batch number 865356 had already expired when they were dispensed (expiration date:…
Safety warnings | Blood & Tissue | 29/11/2012
Persons who have been in Madeira are excluded from donation for 28 days after return.
messages in brief | 20/11/2012
The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local medical press. Publications relating to any adverse drug reactions are to be identified and fed into the…
messages in brief | 16/11/2012
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for…
Replacement | Medicines | 14/11/2012
The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential…
Safety warnings | Medicines | 09/11/2012
The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.