SmPC - Tramadol hydrochloride Capsules 50mg: Change history
View Summary of Product Characteristics (SmPC - Tramadol hydrochloride Capsules 50mg)
Last updated on this site: 16 Jul 2024
To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation, PSUSA/00003002/202306. Consequently, the PIL has been updated. Additionally, the PIL has been updated with minor editorial corrections.
View Summary of Product Characteristics (SmPC - Tramadol hydrochloride Capsules 50mg)
Last updated on this site: 16 Jul 2024
To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation, PSUSA/00003002/202306. Consequently, the PIL has been updated. Additionally, the PIL has been updated with minor editorial corrections.
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Changes: (Updated: 16 Jul 2024)
To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation, PSUSA/00003002/202306. Consequently, the PIL has been updated. Additionally, the PIL has been updated with minor editorial corrections.
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Changes: (Updated: 16 Jan 2023)
Variation Description: To update section 4.4 of the SmPC in line with the reference product, ZYDOL 50mg Capsules (PL 21727/0001, MAH: Grünenthal Ltd.) dated 25th March 2022.
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Changes: (Updated: 22 Sep 2022)
Initial upload