EMEA/H/N/PSR/J/0005 - periodic safety update report single assessment

Cyproterone / ethinylestradiol

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:
  Cyproterone / ethinylestradiol
• Procedure number:
  EMEA/H/N/PSR/J/0005
• Regulatory outcome:
  Variation

Documents

Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006

Reference Number: EMA/68246/2017

Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0005

Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005

Reference Number: EMA/101726/2017