PSUSA/00002907/201512 - periodic safety update report single assessment

Testosterone (all formulations apart from topical use and testosterone undecanoate injection)

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:
  Testosterone (all formulations apart from topical use and testosterone undecanoate injection)
• Procedure number:
  PSUSA/00002907/201512
• Regulatory outcome:
  Variation

Documents

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): List of nationally authorised medicinal products - PSUSA/00002907/201512

Reference Number: EMA/730861/2016

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementa...