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Search results with tag "Type ii va riation"
Tarceva - European Medicines Agency
www.ema.europa.eu1 Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II va riation or extension application or a worksharing application).
Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified)
www.ema.europa.euNotifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II va riation or extension application or a worksharing application). Opinions are issued for all other procedures.
Keytruda - Europa
www.ema.europa.euNotifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II va riation or extension application or a worksharing application). Opinions are issued for all other procedures.