Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VIII)

29 May 2019
4-(methyl)(nitroso)amino)butanoic acid, active substance, angiotensin-II-receptor antagonists, angiotensin-II-receptor blockers, API, ARBs, Article 31, azilsartan, cancer, candesartan, carcinogen, CEP, conditions to MA, diabetes, DIPNA, drug product, EC, EDQM, EIPNA, EMA, eprosartan, European Commission, Hetero Labs, human, hypertension, impurity, interim, investigation, irbesartan, legally binding decision, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing process, manufacturing site, marketing authorisation holder, medicinal product, medicines, N nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, olmesartan, pioglitazone, review, root cause, sartans, scientific conclusion, specific ring structure, suspension, telmisartan, temporary, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,

IMPORTANT! Update [28/10/2020] Having considered the knowledge acquired on the presence of nitrosamines in medicinal products since the sartans referral and taking into account the data assessed within the review under Article 5(3), in particular related to the root causes where it became clear that the root causes can be numerous, concomitant, at

Withdrawal of marketing authorisations for fenspiride medicines!

24 May 2019
benefit-risk balance, CMDh, cough, EMA, EU, fenspiride, heart rhythm problems, MA, medicinal product, medicines, negative, PRAC, QT prolongation, supply, suspended, symptomatic treatment, syrup, tablet, torsades de pointes, withdrawal of MA, withdrawal of marketing authorisation,

EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems. Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness

Medicinal products

22 May 2019
EU, FDA, FDA approved drug products, medicinal products, Poland, register of medicinal products, Russia, union register of medicinal products,

REGISTERS OF MEDICINAL PRODUCTS MEDICINAL PRODUCTS A Azilsartan medoxomil B Bamlanivimab Bamlanivimab/Etesevimab C Candesartan cilexetil Cannabidiol Casirivimab/Imdevimab Chloroquine Cimetidine Clobazam E Eprosartan mesylate Esketamine Esomeprazole F Famotidine Fenspiride hydrochloride G Glucagon H Hydroxychloroquine I Irbesartan L Lansoprazole Losartan potassium M Metformin hydrochloride N Nizatidine O Olmesartan medoxomil Omega-3 fatty acid Omeprazole P Pioglitazone