The marketing authorization holder has informed its supplied customers and medical home pharmacies that a microbiological contamination has been detected in a batch of the drug "Magnesium Verla i.v./i.m. Injection Solution" from Verla-Pharm…

If there are major differences in the measurement of pharmacokinetic parameters, such as the AUC or Cmax, after repeated administration of the identical drug, it is reasonable to suspect that the specific product or the active ingredient itself could…

The distributor informed its supplied customers that during stability tests after a storage period of more than two years the specifications of the product could not be met. An impurity - "Desloratadine Citric Amide" - was detected. As the batches on…

Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain. The European Medicines Agency (EMA) is evaluating the need for a change in the indication of third- and fourth-generation…

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…

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.

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.…

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.

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:…

Persons who have been in Madeira are excluded from donation for 28 days after return.