Rapilysin
Withdrawn
This medicine's authorisation has been withdrawn
reteplase
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 26 January 2024, the European Commission withdrew the marketing authorisation for Rapilysin (reteplase) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Actavis Group PTC ehf., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Rapilysin was granted marketing authorisation in the EU on 29 August 1996 for the treatment of suspected myocardial infarction. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2001. It was then granted unlimited validity in 2006.
Product information
Latest procedure affecting product information:IG1612
31/05/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Rapilysin
- Active substance
- reteplase
- International non-proprietary name (INN) or common name
- reteplase
- Therapeutic area (MeSH)
- Myocardial Infarction
- Anatomical therapeutic chemical (ATC) code
- B01AD07
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.
Topics
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