PSUSA/00010390/202007 - periodic safety update report single assessment

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide

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:
  Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide
• Procedure number:
  PSUSA/00010390/202007
• Regulatory outcome:
  Variation

Documents

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/202007

Reference Number: EMA/197324/2021 Summary:

List of nationally authorised medicinal products

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007

Summary:

CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation