PSUSA/00010346/202111 - periodic safety update report single assessment

Aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin

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:
  Aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin
• Procedure number:
  PSUSA/00010346/202111
• Regulatory outcome:
  Maintenance

Documents

Aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / ... - List of nationally authorised medicinal products - PSUSA/00010346/202111

Reference Number: EMA/38012/2023