Official announcements
messages in brief
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06/06/2017
The spontaneous reporting system for adverse drug reactions is of enormous importance for the early identification of new risks of medicinal products. However, its functioning depends crucially on the cooperation of all healthcare professionals. In…
messages in brief
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24/05/2017
After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively accepted by an independent audit and confirmed by the Pharmacovigilance Risk Assessment Committee (PRAC),…
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…
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…
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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…
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…
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.…
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…