Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Iscover 75 mg film-coated tablets.
Iscover 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Iscover 75 mg film-coated tablets: Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side. Iscover 300 mg film-coated tablets: Pink, oblong, engraved with «300» on one side and «1332» on the other side. |
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Excipients with known effect: Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Excipients with known effect: Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. |
| List of Excipients |
|---|
|
Core: Mannitol (E421) Coating: Hypromellose (E464) Polishing agent: Carnauba wax |
Iscover 75 mg film-coated tablets: PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets. PVC/PVDC/Aluminium or all aluminium unit-dose blister packs in cardboard cartons containing 50x1 film-coated tablets.
Iscover 300 mg film-coated tablets: Aluminium unit-dose blisters in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 film-coated tablets.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Iscover 75 mg film-coated tablets:
EU/1/98/070/001 – Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/002 – Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/003 – Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/004 – Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/005 – Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/006 – Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/007 – Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/011 – Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters
EU/1/98/070/013 – Cartons of 28 film-coated tablets in all aluminium blisters
EU/1/98/070/014 – Cartons of 50x1 film-coated tablets in all aluminium blisters
EU/1/98/070/015 – Cartons of 84 film-coated tablets in all aluminium blisters
EU/1/98/070/016 – Cartons of 100 film-coated tablets in all aluminium blisters
EU/1/98/070/017 – Cartons of 30 film-coated tablets in all aluminium blisters
EU/1/98/070/018 – Cartons of 90 film-coated tablets in all aluminium blisters
EU/1/98/070/019 – Cartons of 14 film-coated tablets in all aluminium blisters
EU/1/98/070/020 – Cartons of 7 film-coated tablets in all aluminium blisters
Iscover 300 mg film-coated tablets:
EU/1/98/070/008 – Cartons of 4x1 film-coated tablets in all aluminium unit-dose blisters
EU/1/98/070/009 – Cartons of 30x1 film-coated tablets in all aluminium unit-dose blisters
EU/1/98/070/010 – Cartons of 100x1 film-coated tablets in all aluminium unit-dose blisters
EU/1/98/070/012 – Cartons of 10x1 film-coated tablets in all aluminium unit-dose blisters
Date of first authorisation: 15 July 1998
Date of latest renewal: 19 June 2008
| Drug | Countries | |
|---|---|---|
| ISCOVER | Austria, Australia, Germany, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.