Human medicines

Valsartan/HCT from Teva B.V.

Recall | Medicines | 23/11/2018

The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan…

Valsartan/HCT from Teva B.V. Read more

Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".

Safety warnings | Medicines | 23/11/2018
Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited". Read more

Novalgin

Recall | Medicines | 20/11/2018

The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination…

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Rapibloc

Recall | Medicines | 13/11/2018

The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of…

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Recall of Jakavi 15 mg tablets due to suspected counterfeiting

Safety warnings | Medicines | 25/10/2018
No acute danger, recall purely as a precautionary measure
Recall of Jakavi 15 mg tablets due to suspected counterfeiting Read more

BCG, mitomycin, mito-extra

Recall | Medicines | 11/10/2018

The marketing authorization holder informed the supplied customers via its distribution partner in a letter dated 01.10.2018 that the urology…

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Jakavi

Recall | Medicines | 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…

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Robinul

Recall | Medicines | 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…

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CO-Valsax and Valsartan-HCT from G.L. Pharma GmbH

Recall | Medicines | 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…

CO-Valsax and Valsartan-HCT from G.L. Pharma GmbH Read more

Valsartan medication review - update.

Safety warnings | Medicines | 03/08/2018
Preliminary risk assessment of NDMA for patients
Valsartan medication review - update. Read more
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