PSUSA/00002052/202410 - periodic safety update report single assessment

Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide

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:
  Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide
• Procedure number:
  PSUSA/00002052/202410
• Regulatory outcome:
  Variation

Documents

Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002052/202410

Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide: List of nationally authorised medicinal products - PSUSA/00002052/202410

Reference Number: EMADOC-1700519818-2354019