SmPC - Clopidogrel 75mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Clopidogrel 75mg Film-coated Tablets)
Last updated on this site: 03 Jul 2023
Description of update: C.I.2.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH
to update section 4.1, 4.2, 4.4, 4.8 and 5.1 of SmPC in-line with reference product information (Plavix 75mg film coated tablets; EU procedure number: EMEA/H/C/000174 - WS2150; MAH: Sanofi Winthrop Industrie, France).
SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1, 10.
Last updated on this site: 03 Jul 2023
Description of update: C.I.2.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH
to update section 4.1, 4.2, 4.4, 4.8 and 5.1 of SmPC in-line with reference product information (Plavix 75mg film coated tablets; EU procedure number: EMEA/H/C/000174 - WS2150; MAH: Sanofi Winthrop Industrie, France).
SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1, 10.
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Changes: (Updated: 03 Jul 2023)
Description of update: C.I.2.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH
to update section 4.1, 4.2, 4.4, 4.8 and 5.1 of SmPC in-line with reference product information (Plavix 75mg film coated tablets; EU procedure number: EMEA/H/C/000174 - WS2150; MAH: Sanofi Winthrop Industrie, France).
SmPC sections updated: 4.1, 4.2, 4.4, 4.8, 5.1, 10.
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Changes: (Updated: 06 Dec 2022)
Section 4.1, 4.3, 4.4, 4.8, 5.1 – Grammar correctionsSection 4.5 - addition of “Rosuvastatin: Clopidogrel has been shown to increase rosuvastatin exposure in patients by 2-fold (AUC) and 1.3-fold (Cmax) after administration of a 300 mg clopidogrel dose, and by 1.4-fold (AUC) without effect on Cmax after repeated administration of a 75 mg clopidogrel dose.”
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Changes: (Updated: 22 Sep 2022)
initial upload