Official announcements
Safety warnings
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messages in brief
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20/04/2018
The European Medicines Agency ( EMA) has launched registration for the public consultation. The consultation will take place on 13/06/2018 at the EMA premises. It will be an opportunity for patients, physicians, healthcare professionals, nurses,…
messages in brief
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17/04/2018
World Hemophilia Day 2018 Hemophilia is a congenital, lifelong increased bleeding tendency in which a deficiency or complete absence of certain blood components (clotting factors) leads to a disturbance of normal hemostasis. Approximately 850,…
Recall
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Medicines
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17/04/2018
The marketing authorization holder has informed its supplied customers in a letter dated April 16, 2018, that a shortfall in the protein nitrogen content was detected during an internal quality control and that the affected batch of the Prick Test…
messages in brief
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12/04/2018
With regard to the APA report "APA0151 5 WI 0205 WB/CI" of Thursday, April 12, 2018, the Federal Office for Safety in Health Care (BASG) takes the liberty of making the following correction: The procedure in question is an official procedure of the…
Recall
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Medicines
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23/03/2018
The marketing authorization holder has informed its supplied customers in a letter dated 23.03.2018 that increased anaphylactic reactions have been reported after administration of an identical product in France. For this reason, the above mentioned…
Recall
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Medicines
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15/03/2018
The marketing authorization holder has informed its supplied customers in a letter dated March 13, 2018, that cases of immune-mediated encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta. This has resulted in an…
Recall
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Medicines
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22/02/2018
The marketing authorization holder has informed its supplied customers in a letter dated 22.02.2018 that it may not be possible to supply all doses. Therefore, the affected batch is recalled from the market as a precautionary measure.
Recall
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Medicines
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14/02/2018
The marketing authorization holder has informed its supplied customers in a letter dated February 13, 2018, that a minor contamination with Iopamidol has been detected in batch PQ0968 of the medicinal product "Zoledronic Acid STADA 4 mg/100 ml…
Recall
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Medicines
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07/02/2018
The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that the translucent white cap on the tip of the BUCCOLAM application syringe can get stuck. This creates the possibility that administration may be…
Recall
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Medicines
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07/02/2018
The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that complaints about loose or rotating metal caps have been received. Therefore, the affected batches are recalled from the market as a precaution.
