SmPC - Atazanavir Accord 300mg Hard Capsules: Change history

Last updated on this site: 29 Dec 2023

Renewal. MHRA renewal approval date: 18/12/2023.

SmPC sections updated: 9 & 10.

Changes: (Updated: 29 Dec 2023)

Renewal. MHRA renewal approval date: 18/12/2023.
SmPC sections updated: 9 & 10.
Changes: (Updated: 30 Nov 2023)

Description of update: Renewal. Date of renewal: unlimited validity.
SmPC Sections updated: 9 and 10.
Changes: (Updated: 18 Sep 2023)

Description of update: The proposed change is: C.I.2.a; update sections 4.4, 4.5, 4.6, 4.8 of SmPC and section 2 of the leaflet in line with the Reference product (Reyataz 100mg/150mg/200mg/300mg Hard Capsules; MAH: Bristol-Myers Squibb Pharmaceuticals limited; EMA procedure number: EMEA/H/C/000494/IB/0136 updated on 17/10/2022).
SmPC sections updated: 4.4, 4.5, 4.6, 4.8 and 10.
Changes: (Updated: 20 Sep 2022)

Initial upload

Changes: (Updated: 29 Dec 2023)