Official announcements
Recall
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Medicines
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24/05/2017
The marketing authorization holder has informed its supplied customers in a letter dated May 23, 2017, that increased black visible particles have been detected in a batch of "Elotrace - Infusion Additive".Based on these observations, the affected batch 16LC6994 is being recalled.
messages in brief
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11/05/2017
The new guide summarizes rules and recommendations related to designations and names of human and veterinary drug specialties and is intended to assist applicants in finding appropriate designations and names. More information: AT Guide to the Designation of Proprietary Medicinal Products.
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04/05/2017
The Austrian Health Portal, operated by GÖG, has a new service for physicians:
"Drug Safety Information Platform".
Recall
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Medicines
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28/04/2017
The marketing authorization holder has informed its supplied customers in a letter dated April 27, 2017, that the affected batches are being recalled due to a possible minor contamination with ethylene glycol. According to current knowledge, the occurrence of side effects due to the contamination for patients is unlikely.
Safety warnings
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messages in brief
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12/04/2017
EpiPen 300 microgram solution for injection in a ready-to-use pen (epinephrine) and EpiPen Junior 150 microgram solution for injection in a ready-to-use pen (epinephrine) have been approved under the MRP/DCP procedure since March 30, 1998 for the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, food,…
Safety warnings
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Medicines
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12/04/2017
Meda Pharma GmbH expands recall of EpiPen auto-injectors to include additional lots
Recall
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Medicines
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12/04/2017
The marketing authorization holder has informed its supplied customers about the extended voluntary recall of additional EpiPen batches in a letter dated April 12, 2017. There is a very low probability that the auto-injector does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen failed to trigger…
Recall
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Medicines
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07/04/2017
The marketing authorization holder has informed its supplied customers in a letter dated April 6, 2017, that individual bottles filled with 100 ml of distilled water were included in the packaging of Buerlecithin liquid 1000 ml. For this reason, this batch is recalled. There is no risk to patient safety
Enforcement
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06/04/2017
European directives relating to medicinal products have to be transposed into national law by the member states. A certain flexibility of this transposition is aimed at the optimal implementation of European requirements into national standards in order to provide for global European interests such as high-quality health care. This relative…
Enforcement
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06/04/2017
For the past few years informations concerning a substance called “GcMAF” have been circulating the internet. Several online sources denote GcMAF as harmless treatment for diverse illnesses, such as autism, different viral infections (HIV, Hepatitis B and C, influenza, etc.), chronic fatigue syndrome, autoimmune diseases (ALS, MS, etc.) and…