Official announcements
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 active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Safety warnings
|
messages in brief
|
03/08/2018
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan,…
Safety warnings
|
Medicines
|
03/08/2018
Preliminary risk assessment of NDMA for patients
messages in brief
|
30/07/2018
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website ( http://esubmission.ema.europa.eu/eaf/ ). Specific information from the BASG are published on…
Recall
|
Medicines
|
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
|
Medicines
|
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
|
Medicines
|
05/07/2018
No acute danger. Discontinuation of medication not recommended
Safety warnings
|
messages in brief
|
05/07/2018
A batch-related recall of medicines containing valsartan, the active ingredient of which was produced by the Chinese manufacturer Zhejiang Huahai Pharmaceutical, is currently taking place in the European Union. The affected drugs are used to treat…
Recall
|
Medicines
|
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
|
Medicines
|
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…