Tom 14, Nr 5 (2019)
Artykuł redakcyjny
Opublikowany online: 2019-10-31
Wyświetlenia strony
475
Wyświetlenia/pobrania artykułu
338
Od Redaktora
DOI: 10.5603/FC.2019.0108
Folia Cardiologica 2019;14(5).
Streszczenie
Brak
Referencje
- EMA.pr.2018.08.10: EMA. Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan produced by another company Zhejiang Tianyu. Press release, document EMA/543774/2018, 10 August 2018. https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines-due-detection-ndma_en.pdf (2019.07.30).
- EDQM.pr.2018.08.28: EDQM: Update on EDQM’s actions following detection of impurity in valsartan. Press release. 28 August 2018, Strasbourg, France. ttps://www.edqm.eu/sites/default/files/pressrelease-update-on-edqm-actions-following-detection-of-impurity-in-valsartan-august2018.pdf (2019.07.30).
- FDA.up.2018.12.20: 12/20/2019: UPDATE — FDA alerts patients and health care professionals to Torrent’s recall of losartan medication due to NDEA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan (2019.07.30).
- EMA.pr.2018.09.13: EMA. Update on review of valsartan medicines: risk from NDMA remains low, a related substance NDEA also being investigated. Press release 13/09/2018, document EMA/585263/2018. https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines_en.pdf (2019.07.30).
- FDA.fnr.2018.09.13: 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. FDA news release. https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-valsartan-products-and-reports-finding-additional (2019.07.30).
- EMA.pr.2018.11.19: EMA. Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity. Press release 19/11/2018, document EMA/809509/2018. URL: https://www.ema.europa.eu/en/documents/press-release/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity_en.pdf (dostęp 2019.07.30). https://www.ema.europa.eu/en/documents/press-release/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity_en.pdf (2019.07.30).
- EDQM.up.CEP2018.11.19: EDQM: Update on the review of CEP applications for sartans, 2018.11.19. Strasbourg, France. https://www.edqm.eu/en/news/update-review-cep-applications-sartans (2019.07.13).
- FDA.up.2018.11.21: 11/21/2018: UPDATE — FDA alerts patients and health care professionals to Mylan’s recall of valsartan products due to NDEA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan (2019.07.30).
- RIS.up.2018.12.24: Europe Update on the review of CEP applications for sartans. Par RIS.WORLD — 24/12/2018. http://www.ris.world/europe-update-on-the-review-of-cep-applications-for-sartans-2/ (2019.07.16).
- FDA.up.2019.01.02: 1/2/2019: UPDATE — FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan (2019.07.30).
