SmPC - Victanyl 12 micrograms/hour Transdermal Patch: Change history
View Summary of Product Characteristics (SmPC - Victanyl 12 micrograms/hour Transdermal Patch)
Last updated on this site: 28 Mar 2024
Description of update: To update section 4.4 of the SmPC in line with the reference product, Durogesic DTrans 12 micrograms/hour transdermal patch (PL 00242/0409; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additionally, section 2 of the SmPC has been updated with an additional warning pertaining to the product name and editorial updates have been made to the PIL. To update section 4.8 of the SmPC in line with the PRAC recommendation PSUSA/00001370/202304 (dysphagia). Consequently, the leaflet has been updated.
SmPC Sections updated: 2, 4.4, 4.8 and 10.
Last updated on this site: 28 Mar 2024
Description of update: To update section 4.4 of the SmPC in line with the reference product, Durogesic DTrans 12 micrograms/hour transdermal patch (PL 00242/0409; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additionally, section 2 of the SmPC has been updated with an additional warning pertaining to the product name and editorial updates have been made to the PIL. To update section 4.8 of the SmPC in line with the PRAC recommendation PSUSA/00001370/202304 (dysphagia). Consequently, the leaflet has been updated.
SmPC Sections updated: 2, 4.4, 4.8 and 10.
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Changes: (Updated: 28 Mar 2024)
Description of update: To update section 4.4 of the SmPC in line with the reference product, Durogesic DTrans 12 micrograms/hour transdermal patch (PL 00242/0409; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additionally, section 2 of the SmPC has been updated with an additional warning pertaining to the product name and editorial updates have been made to the PIL. To update section 4.8 of the SmPC in line with the PRAC recommendation PSUSA/00001370/202304 (dysphagia). Consequently, the leaflet has been updated.
SmPC Sections updated: 2, 4.4, 4.8 and 10.
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Changes: (Updated: 07 Jun 2023)
Variation Description: To update sections 4.2, 4.4, 4.8, and 4.9 of the SmPC and section 2, 3, 4 and 5 of PIL, immediate and outer packaging in line with PRAC recommendations (PSUSA/00001370/202204) for opioid use disorder (OUD) and toxic leukoencephalopathy.
SmPC sections updated – 4.2, 4.4, 4.8, 4.9 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload