PIL - Raponer XL 2mg, 4mg, 8mg Prolonged-release Tablets: Change history
View Patient Information Leaflet (PIL - Raponer XL 2mg, 4mg, 8mg Prolonged-release Tablets)
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.8 of the SmPC and section 4 of PIL in line with the PRAC recommendation PRAC-PSUSA/00002661/202207 for Ropinirole containing products - a causal relationship between ropinirole and spontaneous penile erection. In addition the PIL has been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
PIL sections updated – Heading, 2, 4 and 6.
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.8 of the SmPC and section 4 of PIL in line with the PRAC recommendation PRAC-PSUSA/00002661/202207 for Ropinirole containing products - a causal relationship between ropinirole and spontaneous penile erection. In addition the PIL has been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
PIL sections updated – Heading, 2, 4 and 6.
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Changes: (Updated: 20 Jul 2023)
Variation Description: To update section 4.8 of the SmPC and section 4 of PIL in line with the PRAC recommendation PRAC-PSUSA/00002661/202207 for Ropinirole containing products - a causal relationship between ropinirole and spontaneous penile erection. In addition the PIL has been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
PIL sections updated – Heading, 2, 4 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload