SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
| Fulphila | 10 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 1886.10 | Biological · Prescription | Biosimilar Collaborations Ireland Limited (BCIL) | Valid |
| Grasustek 6 mg per 0.6 ml | 10 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 1765.65 | Biological · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| NEUCYTE | 10 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 1765.65 | Biological · Prescription | Biocon Biologics Limited | Valid |
| NEULASTIM 6MG-0.6ML PRE-FILLED SYRINGE | 6 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 2568.25 | NCE · Prescription | KYOWA KIRIN LIMITED | Valid |
| Neulasta Onpro | 6 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 3531.35 | Biological · Prescription | KYOWA KIRIN LIMITED | Valid |
| Nyvepria | 10 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 1765.65 | Biological · Prescription | Pfizer Europe MA EEIG | Valid |
| Pelgraz 6 mg in 0.6 ml | 10 mg/ml | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 1765.65 | Biological · Prescription | Boston Oncology Arabia | Valid |
| Ziextenzo | 6 mg | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 2095.70 | Biological · Prescription | Sandoz GmbH | Valid |
| NEULASTIM 6MG-0.6ML PRE-FILLED SYRINGE | 10 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 6100.70 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA-ADVERSE REACTION MANAGEMENT; THYROID CANCER-MEDULLARY CARCINOMA-SUPPORTIVE CARE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
| NEULASTA | 6MG/0.6ML | syringe | AMGEN | Prescription | 31 Jan 2002 |
| FULPHILA | 6MG/0.6ML | injectable · injection | MYLAN GMBH | Prescription | 4 Jun 2018 |
| UDENYCA | 6MG/0.6ML | injectable · injection | COHERUS BIOSCIENCES INC | Prescription | 2 Nov 2018 |
| ZIEXTENZO | 6MG/0.6ML | injectable · injection | SANDOZ INC | Prescription | 4 Nov 2019 |
| NYVEPRIA | 6MG/0.6ML | injectable · injection | HOSPIRA INC | Prescription | 10 Jun 2020 |
| FYLNETRA | 6MG/0.6ML | injectable · injection | KASHIV BIOSCIENCES LLC | Prescription | 26 May 2022 |
| STIMUFEND | 6MG/0.6ML | solution · injection | FRESENIUS KABI USA | Prescription | 1 Sep 2022 |
| ARMLUPEG | 6MG/0.6ML | injection · solution | LUPIN LTD | Prescription | 28 Nov 2025 |
| ENNUMO | 6MG/0.6ML | injectable · subcutaneous | ACCORD BIOPHARMA INC. | Prescription | 7 May 2026 |
EMA European Union — centrally authorised medicines
Neulasta Amgen Europe B.V. · Authorised · authorised 22 Aug 2002 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Pelgraz Accord Healthcare S.L.U. · Authorised · authorised 21 Sep 2018 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Pelmeg Mundipharma Corporation (Ireland) Limited · Authorised · authorised 20 Nov 2018 · ATC L03AA13
Therapeutic indication (EMA)
To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
Fulphila Biosimilar Collaborations Ireland Limited · Authorised · authorised 20 Nov 2018 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Ziextenzo Sandoz GmbH · Authorised · authorised 22 Nov 2018 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Grasustek Juta Pharma GmbH · Authorised · authorised 20 Jun 2019 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Cegfila (previously Pegfilgrastim Mundipharma) Mundipharma Corporation (Ireland) Limited · Authorised · authorised 19 Dec 2019 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Nyvepria Pfizer Europe MA EEIG · Authorised · authorised 18 Nov 2020 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Stimufend Fresenius Kabi Deutschland GmbH · Authorised · authorised 28 Mar 2022 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Dyrupeg CuraTeQ Biologics (Malta) Limited · Authorised · authorised 28 Mar 2025 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Vivlipeg Biosimilar Collaborations Ireland Limited · Authorised · authorised 18 Aug 2025 · ATC L03AA13
Therapeutic indication (EMA)
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Efgratin Gedeon Richter Plc. · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia
Zioxtenzo Sandoz GmbH · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia
Fulphila Mylan S.A.S · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Reducing neutropenia in patients taking cancer treatments
Cavoley STADA Arzneimittel AG · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia
Efgratin Gedeon Richter Plc. · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia.
Cavoley Stada Arzneimittel AG · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia.
Lutholaz YES Pharmaceutical Development Services GmbH · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia
Dyrupeg CuraTeQ Biologics s.r.o · Application withdrawn · ATC L03AA13
Therapeutic indication (EMA)
Treatment of neutropenia.
Nylaspeg Qilu Pharma Spain S.L. · Opinion · ATC L03AA13
Therapeutic indication (EMA)
Reduction of neutropoenia in adults
5 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
| FULPHILA | 02484153 | 10 MG / ML | SOLUTION · SUBCUTANEOUS | BIOCON BIOLOGICS CANADA INC |
| LAPELGA | 02474565 | 6 MG / 0.6 ML | SOLUTION · SUBCUTANEOUS | APOTEX INC |
| LAPELGA | 02529343 | 6 MG / 0.6 ML | SOLUTION · SUBCUTANEOUS | APOTEX INC |
| NEULASTA | 02249790 | 10 MG / ML | SOLUTION · SUBCUTANEOUS | AMGEN CANADA INC |
| NIOPEG | 02546973 | 6 MG / 0.6 ML | SOLUTION · SUBCUTANEOUS | NORA PHARMA INC |
| NYVEPRIA | 02506238 | 6 MG / 0.6 ML | SOLUTION · SUBCUTANEOUS | PFIZER CANADA ULC |
| PEXEGRA | 02553945 | 10 MG / ML | SOLUTION · SUBCUTANEOUS | JAMP PHARMA CORPORATION |
| ZIEXTENZO | 02497395 | 6 MG / 0.6 ML | SOLUTION · SUBCUTANEOUS | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
| US NADAC | FULPHILA 6 MG/0.6 ML SYRINGE | $3369.51 | per ML | 23 Sep 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: 6 mg per 0.6 mL in pre-filled syringe
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.