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SmPC- Salbutamol Tablets BP 4mg: Change history

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  • View Summary of Product Characteristics (SmPC- Salbutamol Tablets BP 4mg)

    Last updated on this site: 03 Feb 2026

    To register a reduction in the Shelf-life from 3 years to 2 years for Salbutamol Tablets BP 4mg. Consequently, section 6.3 of the SPC has been updated.

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    • Changes: (Updated: 03 Feb 2026)

      To register a reduction in the Shelf-life from 3 years to 2 years for Salbutamol Tablets BP 4mg. Consequently, section 6.3 of the SPC has been updated.

    • Changes: (Updated: 30 Jan 2026)

      IA, B.II.c.3.z  Change in source of excipient unlikely to present any risk of TSE contamination - Pink colourant change from DISPERSED PINK 15123 to PIGMENT BLEND PB-240054 PINK. Consequential updates to Leaflets and SPC sections 6.1. [impl. date: 30/12/2025]

      Editorial updated of Module 3 sections - sulph to sulf.

    • Changes: (Updated: 07 Nov 2025)

      Update in line with MHRA request to add sleep disturbances as a side effect to section 4.8 of the product SmPC, and to section 4 of the product PIL.

      SmPC sections updated: 4.8 and 10

      Variation Approval 03/11/2025

    • Changes: (Updated: 21 Sep 2022)

      initial upload

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