Is Filgrastim registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Filgrastim, including Accofil 300 mcg/0.5 ml solution For injection/infusion (300 µg, Solution for injection/infusion, SAR 554.75); Accofil 480 mcg/0.5 ml solution For injection/infusion (480 µg, Solution for injection/infusion, SAR 850.60); NEUPOGEN 30 MU (0.6 mg/ml, Solution for injection in pre-filled syringe, SAR 176.40); NEUPOGEN 30 MU (0.3 mg/ml, Solution for injection, SAR 843.70); NIVESTIM 600 mcg Solution for Injection/ Infusion (600 µg, Solution for injection/infusion, SAR 315.55).

Is Filgrastim approved by the US FDA?

Drugs@FDA lists 9 application product lines for Filgrastim, including NEUPOGEN (Prescription); NEUPOGEN (Prescription); ZARXIO (Prescription); NIVESTYM (Prescription); NIVESTYM (Prescription).

Is Filgrastim authorised in the European Union?

EMA lists 7 centrally authorised medicines containing Filgrastim: Ratiograstim, Tevagrastim, Zarzio, Filgrastim Hexal, Nivestim, Accofil, Zefylti.

Is Filgrastim on the WHO Model List of Essential Medicines?

Yes — 8.2.3. Immunomodulators (complementary list): Acquired neutropaenia.

Are there safety signals or safety updates for Filgrastim?

EMA PRAC: 6 entries; US FDA: 4 entries (latest 2026-07-16).

Active substance

Filgrastim

SFDA 17
US FDA 9
EMA 11
Health Canada 13
US price lines 4
NHS prices 2
WHO EML 1
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Accofil 300 mcg/0.5 ml solution For injection/infusion	300 µg	Solution for injection/infusion · Intramuscular and intravenous use	5 Pre-filled syringe	SAR 554.75	Biological · Prescription	Boston Oncology Arabia	Valid
Accofil 480 mcg/0.5 ml solution For injection/infusion	480 µg	Solution for injection/infusion · Intramuscular and intravenous use	5 Pre-filled syringe	SAR 850.60	Biological · Prescription	Boston Oncology Arabia	Valid
NEUPOGEN 30 MU	0.6 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 176.40	Biological · Prescription	KYOWA KIRIN LIMITED	Valid
NEUPOGEN 30 MU	0.3 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 843.70	Biological · Prescription	KYOWA KIRIN LIMITED	Valid
NIVESTIM 600 mcg Solution for Injection/ Infusion	600 µg	Solution for injection/infusion · Intravenous use	5 Pre-filled syringe	SAR 315.55	Biological · Prescription	Pfizer Europe MA EEIG	Valid
NIVESTIM 600 mcg Solution for Injection/ Infusion	600 µg	Solution for injection/infusion · Intravenous use	5 Pre-filled syringe	SAR 788.85	Biological · Prescription	Pfizer Europe MA EEIG	Valid
NIVESTIM 960 mcg Solution for Injection/ Infusion	960 µg	Solution for injection/infusion · Intravenous use	5 Pre-filled syringe	SAR 1262.15	Biological · Prescription	Pfizer Europe MA EEIG	Valid
ZARZIO 30 mU/0.5 mL solution for injection	0.3 mg	Solution for injection/infusion · Intravenous use	5 Pre-filled syringe	SAR 455.30	Biological · Prescription	SANDOZ	Valid
ZARZIO 48 mU/0.5 mL solution for injection	0.48 mg	Solution for injection/infusion · Intravenous use	5 Pre-filled syringe	SAR 725.60	Biological · Prescription	SANDOZ	Valid
NEUPOGEN 30 MU	0.3 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 901.45	Biological · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed
NEUPOGEN 30 MU	0.6 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 188.45	Biological · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed
NEUPOGEN 30 MU	0.6 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	5 Pre-filled syringe	SAR 2471.90	Biological · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
NEUPOGEN 30 MU	0.3 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 459.75	Biological · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
NEUPOGEN 48 MU	480 µ/ml	Solution · Intravenous use	1 Pre-filled syringe	SAR 735.65	Biological · Prescription	ROCHE	Invalid · Not Marketed
NEUPOGEN 48 MU	480 µ/ml	Solution · Intravenous use	5 Vial	SAR 3955.10	Biological · Prescription	ROCHE	Invalid · Not Marketed
ZARZIO 30 mU/0.5 mL solution for injection	0.3 mg	Solution for injection/infusion · Intravenous use	1 Pre-filled syringe	SAR 91.05	Biological · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed
ZARZIO 48 mU/0.5 mL solution for injection	0.48 mg	Solution for injection/infusion · Intravenous use	1 Pre-filled syringe	SAR 145.10	Biological · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); ADULT ACUTE MYELOID LEUKAEMIA (AML); BREAST CANCER EARLY HER-2 -VE -ADVERSE REACTION MANAGEMENT; BREAST CANCER HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); RENAL CELL CARCINOMA (RCC)-ADVERSE REACTION MANAGEMENT; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA-ADVERSE REACTION MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NEUPOGEN	300MCG/1ML; 480MCG/1.6ML	vial	AMGEN	Prescription	20 Feb 1991
NEUPOGEN	300MGC/0.5ML; 480MCG/0.8ML	syringe	AMGEN	Prescription	20 Feb 1991
ZARXIO	300 mcg/0.5 mL; 480 mcg/0.8 mL	injectable · injection	SANDOZ INC	Prescription	6 Mar 2015
NIVESTYM	300MCG/ML; 480MCG/1.6ML	vial · single-dose	HOSPIRA INC	Prescription	20 Jul 2018
NIVESTYM	300MCG/0.5ML; 480MCG/0.8ML	injectable · injection	HOSPIRA INC	Prescription	20 Jul 2018
RELEUKO	300MCG/ML/VIAL; 480MCG/1.6ML/VIAL	solution · intravenous, subcutaneous	KASHIV BIOSCIENCES LLC	Prescription	25 Feb 2022
RELEUKO	300MCG/0.5ML; 480MCG/0.8ML	solution · subcutaneous	KASHIV BIOSCIENCES LLC	Prescription	25 Feb 2022
NYPOZI	300MCG/0.5ML; 480MCG/0.8ML	injectable · injection	TANVEX BIOPHARMA USA INC	Prescription	28 Jun 2024
FILKRI	300MCG/0.5ML; 480MCG/0.8ML	injectable · injection	ACCORD BIOPHARMA INC.	Prescription	15 Jan 2026

EMA European Union — centrally authorised medicines

Ratiograstim Ratiopharm GmbH · Authorised · authorised 15 Sep 2008 · ATC L03AA02

Therapeutic indication (EMA)

Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Ratiograstim is indicated for the treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Tevagrastim Teva GmbH · Authorised · authorised 15 Sep 2008 · ATC L03AA02

Therapeutic indication (EMA)

Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Zarzio Sandoz GmbH · Authorised · authorised 6 Feb 2009 · ATC L03AA02

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Filgrastim Hexal Hexal AG · Authorised · authorised 6 Feb 2009 · ATC L03AA02

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPCs). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of ? 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC ? 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Nivestim Pfizer Europe MA EEIG · Authorised · authorised 7 Jun 2010 · ATC L03AA02

Therapeutic indication (EMA)

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim is indicated for the treatment of persistent neutropenia (ANC ?1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Accofil Accord Healthcare S.L.U. · Authorised · authorised 17 Sep 2014 · ATC L03AA02

Therapeutic indication (EMA)

Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Zefylti CuraTeQ Biologics (Malta) Limited · Authorised · authorised 12 Feb 2025 · ATC L03AA02

Therapeutic indication (EMA)

Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Zefylti are similar in adults and children receiving cytotoxic chemotherapy. Zefylti is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Zefylti is indicated to increase neutrophil counts and to reduce the incidence and duration of infection related events. Zefylti is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Zefylti CuraTeQ Biologics s.r.o · Application withdrawn · ATC L03AA02

Therapeutic indication (EMA)

Filgrastim ratiopharm Ratiopharm GmbH · Withdrawn · authorised 15 Sep 2008 · ATC L03AA02

Therapeutic indication (EMA)

Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Biograstim AbZ-Pharma GmbH · Withdrawn · authorised 15 Sep 2008 · ATC L03AA02

Therapeutic indication (EMA)

Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Grastofil Accord Healthcare S.L.U. · Withdrawn · authorised 18 Oct 2013 · ATC L03AA02

Therapeutic indication (EMA)

Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FILRA	02556537	300 MCG / 0.5 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JAMP PHARMA CORPORATION
FILRA	02556545	480 MCG / 0.8 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JAMP PHARMA CORPORATION
GRASTOFIL	02441489	300 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	APOTEX INC
GRASTOFIL	02454548	480 MCG / 0.8 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	APOTEX INC
NEUPOGEN	01968017	300 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
NEUPOGEN	02420104	600 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC
NEUPOGEN	02420112	600 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
NIVESTYM	02485575	300 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	PFIZER CANADA ULC
NIVESTYM	02485583	480 MCG / 0.8 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	PFIZER CANADA ULC
NIVESTYM	02485591	300 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	PFIZER CANADA ULC
NIVESTYM	02485656	480 MCG / 1.6 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	PFIZER CANADA ULC
NYPOZI	02520990	300 MCG / 0.5 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	TANVEX BIOPHARMA USA, INC.
NYPOZI	02521008	480 MCG / 0.8 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	TANVEX BIOPHARMA USA, INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NEUPOGEN 300 MCG/0.5 ML SYR	$650.052	per ML	23 Sep 2026
US NADAC	NEUPOGEN 300 MCG/ML VIAL	$304.0908	per ML	19 Aug 2026
US NADAC	ZARXIO 300 MCG/0.5 ML SYRINGE	$531.655	per ML	23 Sep 2026
US NADAC	ZARXIO 480 MCG/0.8 ML SYRINGE	$533.4125	per ML	17 Dec 2025
NHS Drug Tariff	Filgrastim 30million units/0.5ml solution for injection pre-filled syringes	£250.75	5 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Filgrastim 30million units/1ml solution for injection vials	£263.52	5 vial	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

8.2.3. Immunomodulators · complementary
Acquired neutropaenia
Parenteral > General injections > SC: 120 µg per 0.2 mL in prefilled syringe; 300 µg per 0.5 mL in prefilled syringe; 480 µg per 0.8 mL in prefilled syringe; 300 µg per mL in 1 mL vial; 480 µg per 1.6 mL in 1.6 mL vial

Safety signals and safety-related labeling changes

US FDA 16 Jul 2026 NEUPOGEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Apr 2025 RELEUKO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Oct 2024 ZARXIO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Feb 2024 NIVESTYM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Feb 2021 PRAC signal: Immune reconstitution inflammatory syndrome (IRIS)
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Immune reconstitution inflammatory syndrome (IRIS)
Action for MAH: update of the product information: No
EMA PRAC 8 Feb 2018 PRAC signal: Aortitis
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2017 PRAC signal: Aortitis
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2013 PRAC signal: Systemic capillary leak syndrome (SCLS) and cytokine release syndrome (CRS)
Action for MAH: update of the product information: Yes
EMA PRAC 31 Oct 2012 PRAC signal: Systemic capillary leak syndrome (SCLS) and cytokine release syndrome (CRS)
Action for MAH: update of the product information: No

All safety entries for filgrastim →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.