Official announcements
messages in brief
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07/11/2017
As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…
Recall
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Medicines
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03/10/2017
In a letter dated September 27, 2017, the marketing authorization holder informed its customers that an incorrect expiration date was printed on batch 7103 of "Coldan Nasal Spray". The expiration date was printed incorrectly as "2022-06" (June 2022),…
messages in brief
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25/09/2017
Vienna (OTS) - The Ministry of Health and AGES Medizinmarktaufsicht/Federal Office for Safety in Health Care Austria, together with the Ministry of the Interior and the Ministry of Finance, were again able to seize numerous illegal medicines this…
Recall
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Medicines
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25/09/2017
"ALK -Abelló Allergie -Service GmbH "has informed its supplied customers in a letter dated 21.09.2017 that bottles of "Pangramin Prick Rye Flour" with brown colored and cloudy solutions have been detected. These solutions can lead to false negative…
messages in brief
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19/09/2017
EMA launches survey for patients and healthcare professionals on knowledge of reporting adverse reactions - Federal Office for Safety in Health Care (BASG) recommends participation The European Medicines Agency (EMA) has launched a -> Survey survey…
Recall
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Medicines
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01/09/2017
"AOP Orphan Pharmaceuticals AG" informed its supplied customers by letter dated August 31, 2017, that "Thromboreductin 1.0 mg Capsules" was placed on the market as a medicinal product not authorized in Austria in this strength with defective…
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…