About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure
Carrageenin / titanium dioxide / zinc oxide, carrageenin / lidocaine / titanium dioxide / zinc oxide, titanium dioxide / zinc oxide / tetracaine hydrochloride
Procedure number
PSUSA/00001869/202006
Regulatory outcome
Maintenance

Documents

Carrageenin / titanium dioxide / zinc oxide, carrageenin / lidocaine / titanium dioxide / zinc oxide, titanium dioxide / zinc oxide / tetracaine hydrochloride: List of nationally authorised medicinal products - PSUSA/00001869/202006

Reference Number: EMA/99398/2021

English (EN) (132.46 KB - PDF)

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