SmPC- Naltrexone hydrochloride 50mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Naltrexone hydrochloride 50mg Film-coated Tablets)
Last updated on this site: 25 Sep 2024
To update the product information to bring in-line with reference product information (Ethylex 50 mg film-coated tablets). Sections 4.4, 4.5, 4.6, 5.1, 5.2 and 5.3 of SmPC and relevant sections of the PIL have been updated.
In addition, there are minor editorial updates in SmPC sections 4.6, 4.9, 5.1, 9, 10 and the PIL, and there are QRD related changes in SmPC sections 4.8, 9 and the PIL
Last updated on this site: 25 Sep 2024
To update the product information to bring in-line with reference product information (Ethylex 50 mg film-coated tablets). Sections 4.4, 4.5, 4.6, 5.1, 5.2 and 5.3 of SmPC and relevant sections of the PIL have been updated.
In addition, there are minor editorial updates in SmPC sections 4.6, 4.9, 5.1, 9, 10 and the PIL, and there are QRD related changes in SmPC sections 4.8, 9 and the PIL
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Changes: (Updated: 25 Sep 2024)
To update the product information to bring in-line with reference product information (Ethylex 50 mg film-coated tablets). Sections 4.4, 4.5, 4.6, 5.1, 5.2 and 5.3 of SmPC and relevant sections of the PIL have been updated.
In addition, there are minor editorial updates in SmPC sections 4.6, 4.9, 5.1, 9, 10 and the PIL, and there are QRD related changes in SmPC sections 4.8, 9 and the PIL
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Changes: (Updated: 21 Sep 2022)
initial upload