SmPC - Propranolol Tablets BP 10mg: Change history
View Summary of Product Characteristics (SmPC - Propranolol Tablets BP 10mg)
Last updated on this site: 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).
Last updated on this site: 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).
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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).
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Changes: (Updated: 30 Mar 2023)
Variation type: IB, B.II.e.1.z
Variation Description:
1. To register 3.2.P.7 Container Closure System - PVC/Al blister pack in line with current expectations and to improve compliance.
2. To remove details of heat seal lacquer from SmPC. Section 6.5 and section 3.2.P.1 are updated.
SmPC section(s) updated– 6.5, 10
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Changes: (Updated: 21 Sep 2022)
Initial upload