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SmPC - Lansoprazole 15mg Gastro-resistant Capsules: Change history

  • Description of update: To update section 4.4 and 4.8 of the SmPC in line with reference product, Zoton FasTab 15 mg, 30 mg oro-dispersible tablets (PL00057/1296, 1297 MAH: Pfizer Limited Dated 01/09/2023). The PIL has been updated accordingly.

    SmPC Sections updated: 4.4, 4.8 and 10.

    • Changes: (Updated: 25 Jan 2024)

      Description of update: To update section 4.4 and 4.8 of the SmPC in line with reference product, Zoton FasTab 15 mg, 30 mg oro-dispersible tablets (PL00057/1296, 1297 MAH: Pfizer Limited Dated 01/09/2023). The PIL has been updated accordingly.

      SmPC Sections updated: 4.4, 4.8 and 10.

    • Changes: (Updated: 21 Jul 2023)

      Variation Description: To update SmPC sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.3 to align with the Reference product following comparison with Zoton FasTab 15, 30 mg oro-dispersible tablets, PL 00057/1296, 1297 (MAH: Pfizer Limited, dated 11/2022). Consequential updates made to the PIL.

      SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.8, 5.3 and 10.

    • Changes: (Updated: 23 Feb 2023)

      Variation Description: To update sections 4.4, and 4.8 of the SPC and section 2 of the leaflet in line with PRAC recommendations (PSUSA/00001827/202112) for tubulointerstitial nephritis (TIN).

      SmPC sections updated – 4.4, 4.8 and 10.

       

    • Changes: (Updated: 06 Dec 2022)

      To update sections 4.4, 4.8 and 5.3 of the SmPC in line with reference product Zoton FasTab* 15 mg oro-dispersible tablets.

      The PIL has not been updated.

       

      SmPC sections updated – 4.4, 4.8, 5.3 (15mg only) and 10

      No update to artwork

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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