PIL - Progesterone 100mg Capsules: Change history
View Patient Information Leaflet (PIL - Progesterone 100mg Capsules)
Last updated on this site: 17 Dec 2025
Description of update: To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 and 4.8 in line with reference product Utrogestan 100mg Capsules (MA number: PL 28397/0003; MAH: Besins Healthcare; Dated 12/03/2025). In addition, editorial updates have been made to SmPC sections 4.3, 4.4, 4.6, 4.8, 5.1 and the PIL. SmPC section 4.8 has been updated in line with MedDRA. The tablet description in PIL section 6 has been updated in line with SmPC section 3. There are QRD updates to the PIL.
Date of approval: 08/12/2025
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
Last updated on this site: 17 Dec 2025
Description of update: To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 and 4.8 in line with reference product Utrogestan 100mg Capsules (MA number: PL 28397/0003; MAH: Besins Healthcare; Dated 12/03/2025). In addition, editorial updates have been made to SmPC sections 4.3, 4.4, 4.6, 4.8, 5.1 and the PIL. SmPC section 4.8 has been updated in line with MedDRA. The tablet description in PIL section 6 has been updated in line with SmPC section 3. There are QRD updates to the PIL.
Date of approval: 08/12/2025
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
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Changes: (Updated: 17 Dec 2025)
Description of update: To update SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7 and 4.8 in line with reference product Utrogestan 100mg Capsules (MA number: PL 28397/0003; MAH: Besins Healthcare; Dated 12/03/2025). In addition, editorial updates have been made to SmPC sections 4.3, 4.4, 4.6, 4.8, 5.1 and the PIL. SmPC section 4.8 has been updated in line with MedDRA. The tablet description in PIL section 6 has been updated in line with SmPC section 3. There are QRD updates to the PIL.
Date of approval: 08/12/2025
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
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Changes: (Updated: 11 Jul 2024)
New product launch 10/07/2024