SmPC - Victanyl 100 micrograms/hour Transdermal Patch: Change history
View Summary of Product Characteristics (SmPC - Victanyl 100 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 25 micrograms/hour transdermal patch (PL 00242/0192; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additional 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: 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 25 micrograms/hour transdermal patch (PL 00242/0192; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additional 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: 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 25 micrograms/hour transdermal patch (PL 00242/0192; MAH: Janssen-Cliag Limited) dated 23rd August 2023. Consequently, the leaflet has been updated. Additional 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: 4.4, 4.8 and 10.
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Changes: (Updated: 19 Dec 2023)
Description of update:
1) Change in the storage conditions of the finished product from 'Do not store above 30°C' to `Do not store above 25°C'. SmPC Sections 6.4, PIL Section 5 and labelling (cartons and front labels) have been updated accordingly.
2) Minor editorial changes to the PIL and label.
SmPC Sections updated: 6.4 and 10.
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Changes: (Updated: 23 Jun 2023)
Variation Description:
To update sections 4.2, 4.4, 4.8 and 4.9 of the SPC to bring in line with the PRAC recommendations (PSUSA/00001370/202204) for opioid use disorder (OUD) and toxic leukoencephalopathy. Consequently, the label and PIL have been updated.
Additional typographical correction in SPC section 4.1 for 75mcg/h strength only.
SmPC sections updated – 4.1(75mcg/h), 4.2, 4.4, 4.8, 4.9 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload