PSUSA/00010582/202509 - periodic safety update report single assessment

allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)

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:
  allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)
• Procedure number:
  PSUSA/00010582/202509
• Regulatory outcome:
  Maintenance

Documents

Allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010582/202509

Reference Number: EMADOC-1700519818-2802158