PSUSA/00000383/202506 - periodic safety update report single assessment

benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin

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:
  benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin
• Procedure number:
  PSUSA/00000383/202506
• Regulatory outcome:
  Maintenance

Documents

Benzylpenicillin, benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine, procaine benzylpenicillin, benzathine benzylpenicillin / procaine benzylpenicillin - List of nationally authorised medicinal products - PSUSA/00000383/202506

Reference Number: EMADOC-1700519818-2983056