Official announcements
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Recall
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Medicines
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08/10/2018
The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade…
Recall
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Medicines
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16/08/2018
The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.
Recall
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Medicines
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14/08/2018
The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Safety warnings
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Medicines
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03/08/2018
Preliminary risk assessment of NDMA for patients
Recall
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Medicines
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06/07/2018
The marketing authorization holder informed its supplied customers in a letter dated 06.07.2018 that a production-related contamination of the active ingredient was detected. The substance in question is N-nitrosodimethylamine (NDMA). Therefore, a…
Recall
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Medicines
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06/07/2018
In a letter dated July 6, 2018, the marketing authorization holder informed its customers that a production-related contamination of the active ingredient has been detected. Therefore, a precautionary recall of all batches of "Valsartan Sandoz…
Safety warnings
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Medicines
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05/07/2018
No acute danger. Discontinuation of medication not recommended
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated July 4, 2018, that the active ingredient valsartan may contain a genotoxic impurity with carcinogenic potential.Based on this information from the active…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated 04.07.2018 that the active ingredient Valsartan may contain a genotoxic impurity with carcinogenic potential. Based on this information from the active…
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a…