SmPC - Gramegran 50 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Gramegran 50 mg Film-coated Tablets)
Last updated on this site: 23 Sep 2025
Description of update:
IAin C.I.3.a: To register an update SmPC sections 4.6, 4.8 & PIL in line with PRAC update (PSUSA/00002832/202409) for a causal relationship between sumatriptan and breast pain in breast-feeding and non-breast-feeding women.
IA A.6: To register an update SmPC section 5.1 in line with WHO ATC Index; the pharmacotherapeutic group has been updated.
Date of approval: 10/09/2025
SmPC sections updated: 4.6, 4.8, 5.1 and 10
Last updated on this site: 23 Sep 2025
Description of update:
IAin C.I.3.a: To register an update SmPC sections 4.6, 4.8 & PIL in line with PRAC update (PSUSA/00002832/202409) for a causal relationship between sumatriptan and breast pain in breast-feeding and non-breast-feeding women.
IA A.6: To register an update SmPC section 5.1 in line with WHO ATC Index; the pharmacotherapeutic group has been updated.
Date of approval: 10/09/2025
SmPC sections updated: 4.6, 4.8, 5.1 and 10
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Changes: (Updated: 23 Sep 2025)
Description of update:
IAin C.I.3.a: To register an update SmPC sections 4.6, 4.8 & PIL in line with PRAC update (PSUSA/00002832/202409) for a causal relationship between sumatriptan and breast pain in breast-feeding and non-breast-feeding women.
IA A.6: To register an update SmPC section 5.1 in line with WHO ATC Index; the pharmacotherapeutic group has been updated.
Date of approval: 10/09/2025
SmPC sections updated: 4.6, 4.8, 5.1 and 10
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Changes: (Updated: 25 Jan 2024)
New product launched. UK launch date: 25/01/2024.