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)
PSUSAHuman

Maltese is available via eTranslation, the European Commission's machine translation service.

Translate to Maltese | Important information about machine translation

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

Dokumenti

Share this page