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 dissolution test of Norgestimat. All other test parameters were within your specification. As TriCilest and…

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. Therefore, the marketing authorization holder recalls various injection solutions. The affected…

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 introduction of the eService "Marketing Authorization and Lifecycle Drug Specialties", the…

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 syringes with particles were sorted out. Nevertheless, both batches CV2391 and CU9980 are recalled as…

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 Arzneimittel GmbH & Co. KG, which is only approved in Germany, was found to be microbiologically…

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 be a "highly variable drug" (HVD). By definition, it is justified to speak of an HVD as soon as the…

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 the market have not yet reached a shelf life of two years, but have a total shelf life of three…

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 preparations. Measures at EU level An increased risk of venous thromboembolism is a known adverse effect of…