SmPC - Prasugrel Accord 5mg Film-coated Tablets: Change history

Last updated on this site: 03 Aug 2023

An Unlimited MA has been granted

Changes: (Updated: 2023-08-03T08:51:05.000000Z)

An Unlimited MA has been granted
Changes: (Updated: 2023-07-21T13:44:09.000000Z)

Renewal approval. Update to SmPC sections 9 and 10 only.
Changes: (Updated: 2023-07-06T13:05:15.000000Z)

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
Changes: (Updated: 2022-09-21T11:56:24.000000Z)

Initial upload

Changes: (Updated: 2023-08-03T08:51:05.000000Z)