PIL - Victanyl 12 micrograms/hour Transdermal Patch: Change history
View Patient Information Leaflet (PIL - Victanyl 12 micrograms/hour Transdermal Patch)
Last updated on this site: 08 Apr 2025
Article 61(3) BROMI Notification:
To update PIL Section 2 in line with PRAC recommendation (PSUSA/00001370/202404) to include the following boxed warning directly under the subheading ‘Dependence and addiction’:
This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.
Last updated on this site: 08 Apr 2025
Article 61(3) BROMI Notification:
To update PIL Section 2 in line with PRAC recommendation (PSUSA/00001370/202404) to include the following boxed warning directly under the subheading ‘Dependence and addiction’:
This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.
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Changes: (Updated: 08 Apr 2025)
Article 61(3) BROMI Notification:
To update PIL Section 2 in line with PRAC recommendation (PSUSA/00001370/202404) to include the following boxed warning directly under the subheading ‘Dependence and addiction’:
This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.
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Changes: (Updated: 28 Feb 2025)
IAin C.I.3.a. MHRA request to include OIVI & PPOU in SmPC 4.3 and PIL.
PIL sections updated 2 and 6.
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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.
PIL sections updated: Introduction, 2, 3, 4 and 6.
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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.
PIL sections updated – 2, 3, 4, 5 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload