Referral (article 31): Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group, valsartan, candesartan, irbesartan, losartan and olmesartan

25 juin 2019

BlueRegWatch

On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) review their manufacturing processes so that they do not produce nitrosamine impurities.
Companies will have a transition period (over 2 years) to make any necessary changes, during which strict temporary limits on levels of these impurities will apply. After this period, companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU.

 

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