Official announcements
Safety warnings
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messages in brief
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11/08/2017
The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance Melphalan) does not have a valid marketing authorization in Austria, but was placed on the market by…
Safety warnings
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Medicines
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11/08/2017
The drug "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" is being recalled due to suspected drug counterfeiting.
Recall
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Medicines
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11/08/2017
The marketing authorization holder has informed its supplied customers in a letter dated August 10, 2017, that a batch of Vibravenous - Ampoules with batch number B113306 is being recalled due to distinct color changes.
Recall
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Medicines
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11/08/2017
"Koanaa Healthcare GmbH" has informed its customers in a letter dated August 10, 2017, that the further marketing of "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" will be stopped and a recall…
Safety warnings
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Blood & Tissue
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27/07/2017
The Federal Office for Public Health Safety was informed by the Greek authority that the first human WNV (neuro-invasive disease) infection was confirmed in the Argolida region (Argos-Mycenae and Nafplio).
Recall
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Medicines
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27/07/2017
"Pascoe Pharm. Präparate GmbH" as the holder of the registration as a homeopathic medicinal speciality of "Quassia Similiaplex drops" has informed its supplied customers by letter dated 26.07.2017 that the registration will be cancelled as of…
Recall
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Medicines
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27/07/2017
The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2017, that a test result within the scope of a stability study showed a reduced active ingredient content. Therefore, the batch 559CG placed on the…
Safety warnings
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Blood & Tissue
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23/07/2017
An increase in Legionnaires’ disease cases is currently being reported in EU travellers returning from Palmanova in Mallorca, Spain. Eighteen cases, one of which was fatal, have been reported, with dates of onset between 11 September 2017 and 7 October 2017.
Safety warnings
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messages in brief
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05/07/2017
NovoPen Echo and NovoPen 5 are used for insulin therapy in people with diabetes. It has been noted that the insulin cartridge holder may tear or break in certain lots of NovoPen Echo and NovoPen 5 insulin pens. Using a pen with a torn/broken…
Recall
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Medicines
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05/07/2017
The marketing authorization holder has informed its supplied customers in a letter dated July 04, 2017, that individual bottles filled with distilled water were included in the packaging of Buerlecithin liquid 500 ml. For this reason, this batch is…
