PSUSA/00010658/202204 - periodic safety update report single assessment

Methyl salicylate, menthol / methyl salicylate, menthol / methyl salicylate / camphor, methyl salicylate/ camphor, methyl salicylate / menthol / camphor / tocopherol, methyl salicylate / camphor / menthol / turpentine (essence, oil), methyl salicylate / menthol / camphor / hydroxyethyl salicylate, methyl salicylate / menthol / camphor / hydroxyethyl salicylate / benzyl nicotinate

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:
  Methyl salicylate, menthol / methyl salicylate, menthol / methyl salicylate / camphor, methyl salicylate/ camphor, methyl salicylate / menthol / camphor / tocopherol, methyl salicylate / camphor / menthol / turpentine (essence, oil), methyl salicylate / menthol / camphor / hydroxyethyl salicylate, methyl salicylate / menthol / camphor / hydroxyethyl salicylate / benzyl nicotinate
• Procedure number:
  PSUSA/00010658/202204
• Regulatory outcome:
  Maintenance

Documents

Methyl salicylate, menthol/methyl salicylate, menthol/methyl salicylate/camphor, methyl salicylate/camphor, methyl salicylate/menthol/camphor....benzyl nicotinate : List of nationally authorised medicinal products - PSUSA/00010658/202204

Reference Number: EMA/918215/2022