Angiotensin-II- receptor antagonists (sartans) containing a tetrazole
5 mars 2021 ... the outcome of the Article 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (EMEA/H/A-31/1471).
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Sartans Art 31 - assessment report
14 févr. 2019 Referral under Article 31 of Directive 2001/83/EC angiotensin-II-receptor antagonists (sartans) containing a tetrazole group.
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Sartans Art 31 - CHMP assessment - impact Nitrosamines Art 5(3
12 nov. 2020 2001/83/EC for angiotensin-II-receptor antagonists (sartans) containing ... Article 31 referral procedure on sartans with a tetrazole ring .
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CMDh Questions & Answers on implementation of outcome of Art
In October 2020 the CHMP concluded that the outcome of the Article 31 referral on angiotensin-II- receptor antagonists (sartans) containing a tetrazole group (
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Nitrosamines: EMA aligns recommendations for sartans with those
13 nov. 2020 Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 ... sartans (also known as angiotensin-II-receptor antagonists).
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Angiotensin-II- receptor antagonists (sartans) containing a tetrazole
The key issue of this referral concerns the detection of N-nitrosamine (esp. The CHMP considered the procedure under Article 31 of Directive 2001/83/EC ...
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Valsartan EMEA/H/A-31/1471
16 juil. 2018 Referral under Article 31 of Directive 2001/83/EC ... Valsartan is an angiotensin-II-receptor antagonist authorised in the EU as a single ...
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Angiotensin-II- receptor antagonists (sartans) containing a tetrazole
17 avr. 2019 On 31 January 2019 EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) ...
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Angiotensin-II- receptor antagonists (sartans) containing a tetrazole
20 sept. 2018 Referral under Article 31 of Directive 2001/83/EC Valsartan- containing medicinal products. We refer to the letter of the European Medicines ...
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April 2019 CMDh press release
30 avr. 2019 Following the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group which concluded on strict ...
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- art. 31 referral on angiotensin-ii-receptor antagonists (sartans)