Integrilin
Withdrawn
This medicine's authorisation has been withdrawn
eptifibatide
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 January 2026, the European Commission withdrew the marketing authorisation for Integrilin (eptifibatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, GlaxoSmithKline (Ireland) Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Integrilin was granted marketing authorisation in the EU on 1 July 1999 for prevention of early myocardial infarction. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2009.
There are other generic medicinal products of eptifibatide authorised and marketed in the EU.
Product information
Latest procedure affecting product information:N/0088
24/09/2021
This medicine’s product information is available in all official EU languages.
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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
- Integrilin
- Active substance
- eptifibatide
- International non-proprietary name (INN) or common name
- eptifibatide
- Therapeutic area (MeSH)
- Angina, Unstable
- Myocardial Infarction
- Anatomical therapeutic chemical (ATC) code
- B01AC16
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.
Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.
Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).
Assessment history
Témák
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