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PIL - Propranolol Tablets BP 10mg, 40mg, 80mg, 160mg: Change history

  • IB C.I.2.a –

    To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Inderal 10 mg film-coated tablets (MAH: Atnahs Pharma UK Limited; MA Number: PL 43252/0036; Dated: 26/04/2022). Consequentially, the PIL and label leaflets have been updated.

     

    Additional updates:

    • Formatting updates to SmPC sections 4.5, 4.8, PIL and label leaflets.

    • Editorial updates to SmPC sections 4.4, 4.5, PIL and label leaflets.

    • QRD updates to the PIL and label leaflets.

    • Tablet description has been updated in the PIL and label leaflets (40mg & 80mg only) in line with SmPC section 3.

    • SmPC section 6.1, 6.3, 6.4, 6.6, 7, 8, and 9 headings have been updated in line with QRD guidelines (10mg only).

    To update the label leaflet laminated area from 114mm to 115mm (10mg & 40mg).

    • Changes: (Updated: 18 Nov 2024)

      IB C.I.2.a –

      To update SmPC sections 4.4, 4.5 and 4.8 in line with the reference product Inderal 10 mg film-coated tablets (MAH: Atnahs Pharma UK Limited; MA Number: PL 43252/0036; Dated: 26/04/2022). Consequentially, the PIL and label leaflets have been updated.

       

      Additional updates:

      • Formatting updates to SmPC sections 4.5, 4.8, PIL and label leaflets.

      • Editorial updates to SmPC sections 4.4, 4.5, PIL and label leaflets.

      • QRD updates to the PIL and label leaflets.

      • Tablet description has been updated in the PIL and label leaflets (40mg & 80mg only) in line with SmPC section 3.

      • SmPC section 6.1, 6.3, 6.4, 6.6, 7, 8, and 9 headings have been updated in line with QRD guidelines (10mg only).

      To update the label leaflet laminated area from 114mm to 115mm (10mg & 40mg).

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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