SmPC - Accofil 70 MU/0.73 ml solution for injection or infusion in pre-filled syringe: Change history
View Summary of Product Characteristics (SmPC - Accofil 70 MU/0.73 ml solution for injection or infusion in pre-filled syringe)
Last updated on this site: 21 Aug 2026
Description of update: Renewal
Date of approval: 18/08/2026
SmPC sections updated: 9 and 10
Last updated on this site: 21 Aug 2026
Description of update: Renewal
Date of approval: 18/08/2026
SmPC sections updated: 9 and 10
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Changes: (Updated: 21 Aug 2026)
Description of update: Renewal
Date of approval: 18/08/2026
SmPC sections updated: 9 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: 21 Oct 2022)
Update
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Changes: (Updated: 21 Sep 2022)
Initial upload