PSUSA/00002370/202001 - periodic safety update report single assessment

Phenobarbital

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:
  Phenobarbital
• Procedure number:
  PSUSA/00002370/202001
• Regulatory outcome:
  Variation

Documents

Phenobarbital: List of nationally authorised medicinal products - PSUSA/00002370/202001

Reference Number: EMA/273764/2021 Summary:

MAHs of medicinal products containing the active substance phenobarbital should also refer to the outcome of the dedicated PSUR follow-up (PSUFU) procedure for phenobarbital (EE/H/PSUFU/00002370/202001): https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/PSUFU/Phenobarbital_PSUFU_AR_2021_04x.pdf

 

Phenobarbital: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002370/202001

Summary:

MAHs of medicinal products containing the active substance phenobarbital should also refer to the outcome of the dedicated PSUR follow-up (PSUFU) procedure for phenobarbital (EE/H/PSUFU/00002370/202001): https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/PSUFU/Phenobarbital_PSUFU_AR_2021_04x.pdf