SmPC - Oxycodone hydrochloride 20mg Capsules, hard: Change history
View Summary of Product Characteristics (SmPC - Oxycodone hydrochloride 20mg Capsules, hard)
Last updated on this site: 05 Nov 2024
To update sections 4.2, 4.4, 4.6, and 4.8 of the SPC in line with the Reference Product, Oxy Norm 5, 10, 20 mg Capsules (PL 16950/0106, 0107, 0108, MAH: Napp Pharmaceuticals Ltd, dated 08/03/2024). Consequently, the PIL has been updated.
Editorial updates made to the PIL in line with the SPC sections 4.2 and 4.4 and QRD.
Last updated on this site: 05 Nov 2024
To update sections 4.2, 4.4, 4.6, and 4.8 of the SPC in line with the Reference Product, Oxy Norm 5, 10, 20 mg Capsules (PL 16950/0106, 0107, 0108, MAH: Napp Pharmaceuticals Ltd, dated 08/03/2024). Consequently, the PIL has been updated.
Editorial updates made to the PIL in line with the SPC sections 4.2 and 4.4 and QRD.
-
Changes: (Updated: 05 Nov 2024)
To update sections 4.2, 4.4, 4.6, and 4.8 of the SPC in line with the Reference Product, Oxy Norm 5, 10, 20 mg Capsules (PL 16950/0106, 0107, 0108, MAH: Napp Pharmaceuticals Ltd, dated 08/03/2024). Consequently, the PIL has been updated.
Editorial updates made to the PIL in line with the SPC sections 4.2 and 4.4 and QRD.
-
Changes: (Updated: 28 Mar 2024)
Description of update: To update sections 4.4 and 4.8 in line with PSUSA/00002254/202204 (Oxycodone and risk of SOD). Consequently, the PIL has been updated. Additional editorial updates have been made to the PIL.
SmPC Sections updated: 4.4, 4.8 and 10.
-
Changes: (Updated: 17 May 2023)
Variation Description: To update sections 4.2, 4.4, 4.8 and 4.9 of the SmPC in line with PRAC recommendations (PSUSA/00002254/202204) for opioid use disorder and overdose. Consequently, the PIL has also been updated.
SmPC sections updated – 4.2, 4.4, 4.8, 4.9 and 10.