SmPC - Tramadol hydrochloride Capsules 50mg: Change history
View Summary of Product Characteristics (SmPC - Tramadol hydrochloride Capsules 50mg)
Last updated on this site: 14 Oct 2025
Description of update:
SmPC sections 4.5 and 4.9 for the above-listed MA have been updated in line with the reference product Zydol 50mg Capsules - PL 21727/0001 (MAH: Grünenthal Ltd.), dated 13/02/2025. Consequential update to the PIL.
Date of approval: 09/10/2025
SmPC sections updated: 4.5, 4.9 and 10.
Last updated on this site: 14 Oct 2025
Description of update:
SmPC sections 4.5 and 4.9 for the above-listed MA have been updated in line with the reference product Zydol 50mg Capsules - PL 21727/0001 (MAH: Grünenthal Ltd.), dated 13/02/2025. Consequential update to the PIL.
Date of approval: 09/10/2025
SmPC sections updated: 4.5, 4.9 and 10.
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Changes: (Updated: 14 Oct 2025)
Description of update:
SmPC sections 4.5 and 4.9 for the above-listed MA have been updated in line with the reference product Zydol 50mg Capsules - PL 21727/0001 (MAH: Grünenthal Ltd.), dated 13/02/2025. Consequential update to the PIL.
Date of approval: 09/10/2025
SmPC sections updated: 4.5, 4.9 and 10.
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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