Preliminary risk assessment of NDMA for patients

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 https://www.basg.gv.at/eservices/elektronisches-antragsformblatt-eaf/ and on…

The Federal Office for Public Health Safety has been informed by the Romanian authority that, in addition to the regions already announced, three confirmed human WNV (meningitis/encephalitis) infections have occurred in the regions of Dolj and Lasi.

Richter Pharma AG" as distributor of the veterinary medicinal product "Doxapram-V", which is approved in Germany, has informed its customers that batch 0617569AA is being recalled by the marketing authorization holder "Albrecht GmbH". The reason is a reduced content of the preservative chlorobutanol. "Doxapram-V" is a veterinary medicinal product…

The Federal Office for Safety in Health Care was informed by the Hungarian authority that two confirmed human WNV infections occurred in Perkata (Fejèr County) and in Balatonfüred (Veszprèm County).

The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT positive mosquito pools have been identified in the regions of Verona, Padua and Rovigo (Veneto Region). For this reason, ID WNV NAT testing is performed for donors of blood and blood components in these regions.

The BASG has been approved by the competent authority in Great Britain (Medicines & Healthcare products Regulatory Agency - MHRA) informs that the products listed are unlawfully available on the market. were brought. The manufacturer has not provided sufficient evidence that the products comply with the comply with legal requirements.

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 precautionary recall of all batches of "Valsartan 1A Pharma Film-Coated Tablets" of the strengths 80mg…

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 Film-Coated Tablets" of the strengths 80mg, 160 mg and 320mg as well as "Valsartan/HCT Sandoz Film-Coated…

No acute danger. Discontinuation of medication not recommended