PIL - Accofil® 30 MU/0.5 ml (0.6 mg/ml) solution for injection or infusion in pre-filled syringe: Change history
View Patient Information Leaflet (PIL - Accofil® 30 MU/0.5 ml (0.6 mg/ml) solution for injection or infusion in pre-filled syringe)
Last updated on this site: 01 Oct 2025
To add Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece as batch testing and batch release site for the finished product. This site is responsible for biological testing, chemical /physical, microbiological: sterility and microbiological: non-sterility testing for filgrastim drug product.
Consequently, the PIL has been updated.
Last updated on this site: 01 Oct 2025
To add Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece as batch testing and batch release site for the finished product. This site is responsible for biological testing, chemical /physical, microbiological: sterility and microbiological: non-sterility testing for filgrastim drug product.
Consequently, the PIL has been updated.
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Changes: (Updated: 01 Oct 2025)
To add Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece as batch testing and batch release site for the finished product. This site is responsible for biological testing, chemical /physical, microbiological: sterility and microbiological: non-sterility testing for filgrastim drug product.
Consequently, the PIL has been updated.
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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).
PIL sections updated: Product title, 6.
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Changes: (Updated: 02 Aug 2023)
File name updated
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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