The marketing authorization holder informed its supplied customers in a letter dated June 18, 2013, that due to an individual complaint from the German market regarding a plastic ampoule leaking at the neck of the bottle, batch 12FHL21 will be…

The marketing authorization holder informed its supplied customers in a letter dated June 4, 2013, that individual bottles of the batch 1112208AE of the product Vitasol AD3EC Injection Solution for Animals, package size 5 x 100 ml, had been placed on…

The marketing authorization holder informed its supplied customers in a letter dated June 3, 2013, that in the course of stability tests after 24 months of storage, non-specification-compliant results were found for a batch of Cileste in the…

The marketing authorization holder has informed its supplied customers in a letter dated 24.05.2013 that particles were observed in some vials. For this reason, the above mentioned batches are recalled as a precautionary measure.

During a routine test, leaks in the area of the predetermined breaking point at the neck of an amber glass ampoule of the size 1 ml were discovered in a product batch that has not yet been released, which are due to a material defect in the glass.…

Methotrexate (various preparations)

As of 01.07.2013, the transmission of Austrian product information texts is to take place via the eService "Marketing Authorization and Lifecycle Drug Specialties ". The e-mail address spc@ages.at will no longer be available as of 31.01.2014. With…

The marketing authorization holder informed its customers in a letter dated April 18, 2013, that due to a technical defect during production, isolated particles were observed in the prefilled syringes. In the course of a 100% inspection, prefilled…

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…