Search results with tag "Nitrosamine impurities in human medicinal products"
Questions and answers for marketing authorisation holders ...
www.ema.europa.eunitrosamine impurities in human medicinal products provides general guidance and recommendations on mitigating and preventing the presence of nitrosamines in human medicinal products. In this context all MAHs/Applicants of human medicinal products should work with the manufacturers of their
厚生労働省医薬・生活衛生局医薬品審査管理課長 （ 公 印 省 …
www.mhlw.go.jpAssessment report：Nitrosamine impurities in human medicinal products. Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. FDAのガイダンス注
Procedure under Article 5(3) of Regulation EC (No) 726 ...
www.ema.europa.euCommittee for Medicinal Products for Human Use (CHMP) Assessment report . Procedure under Article 5(3) of Regulation EC (No) 726/2004 . Nitrosamine impurities in human medicinal products . Procedure number: EMEA/H/A-5(3)/1490 . Note: Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted.