PSUSA/00010800/202311 - periodic safety update report single assessment

Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba / Glycyrrhiza glabra L., radix

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:
  Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba / Glycyrrhiza glabra L., radix
• Procedure number:
  PSUSA/00010800/202311
• Regulatory outcome:
  Maintenance

Documents

Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., : List of nationally authorised medicinal products - PSUSA/00010800/202311