PIL - Prasugrel Accord 5mg, 10mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Prasugrel Accord 5mg, 10mg Film-coated Tablets)
Last updated on this site: 08 Feb 2024
Description of update: Name change of the manufacturing, quality control testing, packaging and batch release site: from "Laboratorios Lesvi, S.L." to "Neuraxpharm Pharmaceuticals, S.L.". The address "Avda. Barcelona 69, 08970 Sant Joan Despí (Barcelona), Spain" is still the same.
PIL sections updated: 6 only.
Last updated on this site: 08 Feb 2024
Description of update: Name change of the manufacturing, quality control testing, packaging and batch release site: from "Laboratorios Lesvi, S.L." to "Neuraxpharm Pharmaceuticals, S.L.". The address "Avda. Barcelona 69, 08970 Sant Joan Despí (Barcelona), Spain" is still the same.
PIL sections updated: 6 only.
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Changes: (Updated: 08 Feb 2024)
Description of update: Name change of the manufacturing, quality control testing, packaging and batch release site: from "Laboratorios Lesvi, S.L." to "Neuraxpharm Pharmaceuticals, S.L.". The address "Avda. Barcelona 69, 08970 Sant Joan Despí (Barcelona), Spain" is still the same.
PIL sections updated: 6 only.
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Changes: (Updated: 06 Jul 2023)
Variation Description: SmPC section 4.4 has been updated in line with the reference product Efient (EMEA/H/C/000984) and the excipient guideline. Consequential update to the PIL. SmPC section 2 has been updated to include the excipient sucrose stearate.
SmPC sections updated – 2, 4.4 and 10
PIL sections updated – Heading, 2, 5 and 6
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Changes: (Updated: 21 Sep 2022)
Initial upload