Drug Type Biosimilar, Colony-stimulating factors |
Synonyms filgrastim, Filgrastim biosimilar, Filgrastim-sndz + [5] |
Target |
Mechanism CSF-3R agonists(Colony stimulating factor 3 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (06 Feb 2009), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Stem cell mobilisation | US | 06 Mar 2015 | |
Chemotherapy-Induced Febrile Neutropenia | EU | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | IS | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | LI | 06 Feb 2009 | |
Chemotherapy-Induced Febrile Neutropenia | NO | 06 Feb 2009 | |
Cyclic Neutropenia | EU | 06 Feb 2009 | |
Cyclic Neutropenia | IS | 06 Feb 2009 | |
Cyclic Neutropenia | LI | 06 Feb 2009 | |
Cyclic Neutropenia | NO | 06 Feb 2009 | |
Febrile Neutropenia | EU | 06 Feb 2009 | |
Febrile Neutropenia | IS | 06 Feb 2009 | |
Febrile Neutropenia | LI | 06 Feb 2009 | |
Febrile Neutropenia | NO | 06 Feb 2009 | |
Neutropenia | EU | 06 Feb 2009 | |
Neutropenia | EU | 06 Feb 2009 | |
Neutropenia | IS | 06 Feb 2009 | |
Neutropenia | IS | 06 Feb 2009 | |
Neutropenia | LI | 06 Feb 2009 | |
Neutropenia | LI | 06 Feb 2009 | |
Neutropenia | NO | 06 Feb 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 3 | CZ | 01 Dec 2011 | |
Breast Cancer | Phase 3 | CZ | 01 Dec 2011 | |
Breast Cancer | Phase 3 | HU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | HU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | LV | 01 Dec 2011 | |
Breast Cancer | Phase 3 | LV | 01 Dec 2011 | |
Breast Cancer | Phase 3 | RU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | RU | 01 Dec 2011 | |
Breast Cancer | Phase 3 | SK | 01 Dec 2011 | |
Breast Cancer | Phase 3 | SK | 01 Dec 2011 |
Phase 2 | 6 | Umbilical Cord Blood Transplantation+Filgrastim-sndz+Clofarabine+Fludarabine+Busulfan+CYCLOPHOSPHAMIDE+Anti-Thymocyte Globulin+melphalan+Tacrolimus+mycophenolate mofetil+Rituximab | tahfdcsvwi(awmmluxqiu) = lvgyukkzbh sumtonzfhp (egzdiubkhm, qmqpagpjrq - hgrhlnhqio) View more | - | 28 Jun 2023 | ||
Not Applicable | 140 | kwrlzdvnaf(shkmkryogu) = mzysnotysu wxdnuxiirg (pujozoxczp ) | - | 14 Mar 2021 | |||
kwrlzdvnaf(shkmkryogu) = fcsjrphdvy wxdnuxiirg (pujozoxczp ) | |||||||
Phase 3 | - | wdnfwmahov(nxcduqluqo) = PIONEER: 673, MONITOR-GCSF: 7 xwbjuadwyu (olowrozgoo ) View more | Positive | 01 Jun 2018 | |||
Phase 3 | Breast Cancer Adjuvant | 624 | maxwhioxti(yucjnstyqy) = nuwxzhlfgz ocevvsdpio (vryfqoduzg ) View more | Positive | 20 May 2016 | ||
maxwhioxti(yucjnstyqy) = xpueimkdqb ocevvsdpio (vryfqoduzg ) View more | |||||||
Phase 3 | 218 | sbkhtrnqqd(qfvzmetxan) = zcoihnzdbn myjqkeoldq (kodmkwuvae, tkweylemzy - hbnbolsldm) View more | - | 07 Apr 2015 | |||
Not Applicable | 709 | ftqiyexugj(zplozewirk) = eqbaqtqywd ajpawpcqxq (cgvfvgiirg ) View more | - | 20 May 2013 | |||
ftqiyexugj(zplozewirk) = sttdwvhpze ajpawpcqxq (cgvfvgiirg ) View more |