PIL - Rabeprazole 10mg, 20mg Gastro-resistant Tablets: Change history

Last updated on this site: 14 Aug 2023

Website administration only- no changes to file.

Changes: (Updated: 14 Aug 2023)

Website administration only- no changes to file.
Changes: (Updated: 27 Feb 2023)

Variation Description: To register at the request of the MHRA to update leaflet warning for rabeprazole - Section 2 -reduced vitamin B12 absorption.
PIL section(s) updated – 2 & 6.
Changes: (Updated: 21 Oct 2022)

Single Variation
Variation Type: IAIN, C.I.z

Variation Description: SmPC & PIL update in line with PRAC recommendations (Acute Tubulointerstitial nephritis (TIN)).

SmPC sections updated – 4.4, 4.8 and 10
PIL sections updated – 2 and 6.
Changes: (Updated: 21 Sep 2022)

Initial upload

Changes: (Updated: 14 Aug 2023)