SmPC - Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe: Change history
View Summary of Product Characteristics (SmPC - Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe)
Last updated on this site: 26 Jun 2025
Description of update: To update sections 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1 and 5.2 and the PIL in line with the reference product Neupogen, Singleject 30 MU (0.6 mg/mL) & 48 MU (0.96 mg/mL) solution for injection in a pre-filled syringe (PL 16216/0043-0044, MAH: Amgen Europe B.V).
SmPC sections updated: 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2 and 10.
Last updated on this site: 26 Jun 2025
Description of update: To update sections 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1 and 5.2 and the PIL in line with the reference product Neupogen, Singleject 30 MU (0.6 mg/mL) & 48 MU (0.96 mg/mL) solution for injection in a pre-filled syringe (PL 16216/0043-0044, MAH: Amgen Europe B.V).
SmPC sections updated: 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2 and 10.
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Changes: (Updated: 26 Jun 2025)
Description of update: To update sections 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1 and 5.2 and the PIL in line with the reference product Neupogen, Singleject 30 MU (0.6 mg/mL) & 48 MU (0.96 mg/mL) solution for injection in a pre-filled syringe (PL 16216/0043-0044, MAH: Amgen Europe B.V).
SmPC sections updated: 2, 4.2, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2 and 10.
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Changes: (Updated: 02 Aug 2023)
To update sections 2, 3, 4.2, 4.4, 4.6, 4.8, 5.1, 5.2, 5.3, 6.2, 6.6 of the SmPC and PIL, in line with the reference product information Neupogen, Singleject 30 MU (0.6 mg/mL) & 48 MU (0.96 mg/mL) solution for injection in a pre-filled syringe) by MAH Amgen Europe B.V. PL 16216/0043.
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Changes: (Updated: 16 Nov 2022)
Name updated
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Changes: (Updated: 21 Sep 2022)
Initial upload