SmPC - Raponer XL 4mg Prolonged-release Tablets: Change history
View Summary of Product Characteristics (SmPC - Raponer XL 4mg Prolonged-release Tablets)
Last updated on this site: 13 Mar 2024
Description of update: To update sections 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC in line with reference product Requip® XL 2 mg, 4 mg, 8 mg prolonged-release tablets (PL: 10592/0293, 0295, 0296; MAH: GlaxoSmithKline UK; Dated: 22/09/2023). Additional editorial and formatting updates have been made to sections 4.2, 4.4, 4.8 and 5.1 of the SmPC, and section 4.8 of the SmPC has been updated in line with MedDRA.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3.
Last updated on this site: 13 Mar 2024
Description of update: To update sections 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC in line with reference product Requip® XL 2 mg, 4 mg, 8 mg prolonged-release tablets (PL: 10592/0293, 0295, 0296; MAH: GlaxoSmithKline UK; Dated: 22/09/2023). Additional editorial and formatting updates have been made to sections 4.2, 4.4, 4.8 and 5.1 of the SmPC, and section 4.8 of the SmPC has been updated in line with MedDRA.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3.
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Changes: (Updated: 13 Mar 2024)
Description of update: To update sections 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC in line with reference product Requip® XL 2 mg, 4 mg, 8 mg prolonged-release tablets (PL: 10592/0293, 0295, 0296; MAH: GlaxoSmithKline UK; Dated: 22/09/2023). Additional editorial and formatting updates have been made to sections 4.2, 4.4, 4.8 and 5.1 of the SmPC, and section 4.8 of the SmPC has been updated in line with MedDRA.
SmPC Sections updated: 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3.
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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.
SmPC sections updated – 4.8 and 10.
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Changes: (Updated: 16 Jan 2023)
Variation Description: To update section 4.8 of the SmPC for Raponer XL 2mg, 4 mg and 8 mg Prolonged-release Tablets in line with product Requip® XL 2, 4, 8 mg prolonged-release tablets (PL 10592/0293, 0295, 0296, MAH: SmithKline Beecham Limited) dated 20th January 2022.
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Changes: (Updated: 21 Sep 2022)
Initial upload