83-200, г. Starogard Gdanski, Koteze, ул. Sokola 1, Польша
Tел./факс: (+48) 58 531 02 59
Tел: (+48) 606 93 82 51

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

  • 29 мая 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,
  On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers, ARBs) review their manufacturing processes so that they do not produce nitrosamine impurities. An initial investigation report on the root cause of the presence of N-nitrosodimethylamine (NDMA) provided by Zhejiang Huahai Pharmaceutical, China upon
Читайте дальше

Withdrawal of marketing authorisations for fenspiride medicines!

  • 24 мая 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, дополнительные исследования, удлинение интервалов QT на электрокардиограмме, фенспирид,
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
Читайте дальше

Лекарственные средства

  • 22 мая 2019
  • EC, FDA, Russia, Европейский союз, лекарственные препараты, лекарственные средства, реестр лекарственных средств,
REGISTERS OF MEDICINAL PRODUCTS     MEDICINAL PRODUCTS A Azilsartan medoxomil Азилсартана медоксомил C Candesartan cilexetil Кандесартана цилексетил Cannabidiol Каннабидиол Cimetidine Циметидин Clobazam Клобазам E Eprosartan mesylate Эпросартана мезилат Esketamine Эскетамин Esomeprazole Эзомепразол F Famotidine Фамотидин Fenspiride hydrochloride Фенспирида гидрохлорид G Glucagon Глюкагон I Irbesartan Ирбесартан L Lansoprazole Лансопразол Losartan potassium Лозартан калия M Metformin
Читайте дальше