1. EMA reviewing medicines containing valsartan from Zhejiang Huahai
following detection of an impurity: some valsartan medicines being
recalled across the EU. European Medicines
Agency. July 5, 2018, https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity-some.
2. FDA provides update on its ongoing investigation
into valsartan products;
and reports on the finding of an additional impurity identified in
one firm’s already recalled products. U.S. Food & Drug Administration. September 13, 2018, https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-valsartan-products-and-reports-finding-additional.
3. FDA Updates and Press Announcements on Angiotensin
II Receptor Blocker
(ARB) Recalls (Valsartan, Losartan, and Irbesartan). U.S. Food & Drug Administration. July 13, 2018, https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan#5cc3b83d3b22e.
4. European Commission. COMMISSION IMPLEMENTING DECISION
of 2.4.2019 concerning,
in the framework of Article 31 of Directive 2001/83/EC of the European
Parliament and of the Council, the marketing authorisations of medicinal
products for human use which contain the active substance “candesartan”,
“irbesartan”, “losartan”, “olmesartan”,
“valsartan”, 2019. https://ec.europa.eu/health/documents/community-register/2019/20190402144194/dec_144194_en.pdf
5. Lessons learnt from presence of N-nitrosamine
impurities in sartan
medicines. https://www.ema.europa.eu/en/documents/report/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf.