PSUSA/00010542/201912 - periodic safety update report single assessment

Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract

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:
  Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract
• Procedure number:
  PSUSA/00010542/201912
• Regulatory outcome:
  Variation

Documents

Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract: List of nationally authorised medicinal products - PSUSA/00010542/201912

Reference Number: EMA/599982/2020 Summary:

List of nationally authorised medicinal products

Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate...:CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010542/201912

Summary:

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