Biosimilar medicines authorized by the European Commission

86 authorized medicines

24 active principles

Wyost

Wyost®

ACTIVE PRINCIPLE:
Denosumab

INDICATION:
Giant cell bone tumor
Bone tissue neoplasms

DATE:
17/05/2024

STATUS:
Authorized

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Omlyclo

Omlyclo®

ACTIVE PRINCIPLE:
Omalizumab

INDICATION:
Asthma
Urticaria

DATE:
16/05/2024

STATUS:
Authorized

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Jubbonti

Jubbonti®

ACTIVE PRINCIPLE:
Denosumab

INDICATION:
Osteoporosis
Postmenopausal osteoporosis
bone resorption

DATE:
16/05/2024

STATUS:
Authorized

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Pyzchiva

Pyzchiva®

ACTIVE PRINCIPLE:
Believable

INDICATION:
Crohn's disease
Ulcerative colitis
Psoriasic arthritis

DATE:
19/04/2024

STATUS:
Authorized

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Rimmyrah

Rimmyrah®

ACTIVE PRINCIPLE:
Ranibizumab

INDICATION:
wet macular degeneration
Macular edema
diabetic complications
degenerative myopia
Choroidal neovascularization

DATE:
05/01/2024

STATUS:
Authorized

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Uzpruvo

Uzpruvo®

ACTIVE PRINCIPLE:
Believable

INDICATION:
plaque psoriasis
Psoriasic arthritis
Crohn's disease
Ulcerative colitis

DATE:
05/01/2024

STATUS:
Authorized

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Herwenda®

Herwenda®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
15/11/2023

STATUS:
Authorized

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Tyruko®

Tyruko®

ACTIVE PRINCIPLE:
natalizumab

INDICATION:
Multiple sclerosis

DATE:
22/09/2023

STATUS:
Authorized

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Yesafili®

Yesafili®

ACTIVE PRINCIPLE:
Aflibercept

INDICATION:
Macular edema
retinal vein occlusion
Diabetic retinopathy
degenerative myopia
diabetic complications

DATE:
15/09/2023

STATUS:
Authorized

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Tyenne®

Tyenne®

ACTIVE PRINCIPLE:
Tocilizumab
INDICATION:
Rheumatoid Arthritis
Cytokine release syndrome
Juvenile rheumatoid arthritis
COVID-19 virus infection
Giant cell arteritis
DATE:
15/09/2023
STATUS:
Authorized

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Epysqli®

EPYSQLI®

ACTIVE PRINCIPLE:
eculizumab

INDICATION:
paroxysmal hemoglobinuria
Atypical hemolytic uremic syndrome

DATE:
26/05/2023

STATUS:
Authorized

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Bekemv®

BEKEMV®

ACTIVE PRINCIPLE:
eculizumab

INDICATION:
paroxysmal hemoglobinuria
Atypical hemolytic uremic syndrome

DATE:
19/04/2023

STATUS:
Authorized

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Sondelbay®

Sondelbay®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
24/03/2022

STATUS:
Authorized

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Kauliv®

Kauliv®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
12/01/2023

STATUS:
Authorized

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Ximluci®

Ximluci®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
diabetic complications
DATE:
9/11/2022
STATUS:
Authorized

MORE INFORMATION

Ranivisio®

Ranivisio®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
diabetic complications
DATE:
25/08/2022
STATUS:
Authorized

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Vegzelma®

Vegzelma®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
17/08/2021
STATUS:
Authorized

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Truvelog Mix 30®

Truvelog Mix 30®

ACTIVE PRINCIPLE:
insulin aspart
INDICATION:
Diabetes Mellitus
DATE:
25/04/2022
STATUS:
Authorized

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Stimufend®

Stimufend®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
28/03/2022

STATUS:
Authorized

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Hukyndra®

Hukyndra®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Psoriasic arthritis
Juvenile rheumatoid arthritis
Rheumatoid Arthritis
Ulcerative colitis
Crohn's disease
Hidradenitis suppurativa
Psoriasis
Ankylosing spondylitis
Uveitis

DATE:
15/11/2021

STATUS:
Authorized

MORE INFORMATION

Libmyris®

Libmyris®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Ankylosing spondylitis
Psoriasic arthritis
Psoriasis
Hidradenitis suppurativa
Crohn's disease
Ulcerative colitis
Uveitis

DATE:
12/11/2021

STATUS:
Authorized

MORE INFORMATION

Byooviz®

Byooviz®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
degenerative myopia
DATE:
18/08/2021
STATUS:
Authorized

MORE INFORMATION

Abevmy®

Abevmy®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
21/04/2021
STATUS:
Authorized

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Alymsys®

Alymsys®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
26/03/2021
STATUS:
Authorized

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Oyavas®

Oyavas®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
26/03/2021
STATUS:
Authorized

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Yuflyma®

Yuflyma®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasis
Psoriasic arthritis
Ankylosing spondylitis
Uveitis
Ulcerative colitis
Crohn's disease
Hidradenitis suppurativa

DATE:
11/02/2021

STATUS:
Authorized

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Kirsty® (formerly Kixelle®)

Kirsty® (formerly Kixelle®)

ACTIVE PRINCIPLE:
insulin aspart
INDICATION:
Diabetes Mellitus
DATE:
05/02/2021
STATUS:
Authorized

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Onbevzi®

Onbevzi®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
11/01/2021
STATUS:
Authorized

MORE INFORMATION

Nyvepria®

Nyvepria®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
18/11/2020

STATUS:
Authorized

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Livogiva®

Livogiva®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
20/10/2020

STATUS:
Authorized

MORE INFORMATION

Aybintio®

Aybintio®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
02/09/2020
STATUS:
Authorized

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Zercepac®

Zercepac®

ACTIVE PRINCIPLE:
trastuzumab
INDICATION:
Breast cancer
Stomach cancer
DATE:
27/07/2020
STATUS:
Authorized
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Insulin aspart Sanofi®

Insulin aspart Sanofi®

ACTIVE PRINCIPLE:
insulin aspart
INDICATION:
Diabetes Mellitus
DATE:
25/06/2020
STATUS:
Authorized

MORE INFORMATION

Nepexto®

Nepexto®

ACTIVE PRINCIPLE:
etanercept

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasic arthritis
spondyloarthropathies
Ankylosing spondylitis
Psoriasis
DATE:
20/05/2020
STATUS:
Authorized

MORE INFORMATION

Ruxience®

Ruxience®

ACTIVE PRINCIPLE:
Rituximab

INDICATION:
B-cell chronic lymphocytic leukemia
Rheumatoid Arthritis
microscopic polyangiitis
Pemphigus

DATE:
01/04/2020

STATUS:
Authorized

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Amsparity®

Amsparity®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasis
Psoriasic arthritis
Ankylosing spondylitis
Uveitis
Ulcerative colitis
Crohn's disease
Hidradenitis suppurativa

DATE:
13/02/2020

STATUS:
Authorized

MORE INFORMATION

Cegfila®

Cegfila®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
19/12/2019

STATUS:
Authorized

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Grasustek®

Grasustek®

ACTIVE PRINCIPLE:
pegfilgrastim

INDICATION:
neutropenia

DATE:
26/04/2019

STATUS:
Authorized

MORE INFORMATION

Idacio®

Idacio®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasic arthritis
Ulcerative colitis
Crohn's disease
Psoriasis
Ankylosing spondylitis
Hidradenitis suppurativa
Uveitis

DATE:
02/04/2019

STATUS:
Authorized

MORE INFORMATION

Zirabev®

Zirabev®

ACTIVE PRINCIPLE:
bevacizumab

INDICATION:
Colon or rectal carcinoma
Breast cancer
Non-small cell lung cancer
renal cell cancer
Cervical cancer

DATE:
14/02/2019

STATUS:
Authorized

MORE INFORMATION

Ogivri®

Ogivri®

ACTIVE PRINCIPLE:
trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
12/12/2018

STATUS:
Authorized

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Ziextenzo®

Ziextenzo®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
22/11/2018

STATUS:
Authorized

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Pelmeg®

Pelmeg®

ACTIVE PRINCIPLE:
pegfilgrastim

INDICATION:
neutropenia

DATE:
20/11/2018

STATUS:
Authorized

MORE INFORMATION

Fulphila®

Fulphila®

ACTIVE PRINCIPLE:
pegfilgrastim

INDICATION:
neutropenia

DATE:
20/11/2018

STATUS:
Authorized

MORE INFORMATION

Pelgraz®

Pelgraz®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
25/09/2018

STATUS:
Authorized

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Hulio®

Hulio®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
17/09/2018

STATUS:
Authorized

MORE INFORMATION

Trazimera®

Trazimera®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
breast and stomach cancer

DATE:
26/07/2018

STATUS:
Authorized

MORE INFORMATION

Hyrimoz®

Hyrimoz®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
papulosquamous diseases
Juvenile rheumatoid arthritis

DATE:
26/07/2018

STATUS:
Authorized

MORE INFORMATION

Hefiya®

Hefiya®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Ankylosing spondylitis
Arthritis
Uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
26/07/2018

STATUS:
Authorized

MORE INFORMATION

Zessly®

Zessly®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Ankylosing spondylitis
Rheumatoid arthritis
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
18/05/2018

STATUS:
Authorized

MORE INFORMATION

Kanjinti®

Kanjinti®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
16/05/2018

STATUS:
Authorized

MORE INFORMATION

Semglee®

Semglee®

ACTIVE PRINCIPLE:
Insulin glargine

INDICATION:
Diabetes mellitus type 2

DATE:
23/03/2018

STATUS:
Authorized

MORE INFORMATION

Herzuma®

Herzuma®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
09/02/2018

STATUS:
Authorized

MORE INFORMATION

Mvasi®

Mvasi®

ACTIVE PRINCIPLE:
Bevacizumab

INDICATION:
Colon or rectal carcinoma
Breast cancer
Non-small cell lung cancer
renal cell cancer
Ovarian, fallopian tube and peritoneal cancer
Cervical cancer

DATE:
15/01/2018

STATUS:
Authorized

MORE INFORMATION

Ontruzant®

Ontruzant®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
15/11/2017

STATUS:
Authorized

MORE INFORMATION

Imraldi®

Imraldi®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
Arthritis
Uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
24/08/2017

STATUS:
Authorized

MORE INFORMATION

Insulin lispro Sanofi®

Insulin lispro Sanofi®

ACTIVE PRINCIPLE:
insulin lispro

INDICATION:
Diabetes Mellitus

DATE:
19/07/2017

STATUS:
Authorized

MORE INFORMATION

Blitzima®

Blitzima®

ACTIVE PRINCIPLE:
rituximab

INDICATION:
Non-Hodgkin lymphoma
b-cell chronic lymphocytic leukemia

DATE:
13/07/2017

STATUS:
Authorized

MORE INFORMATION

Erelzi®

Erelzi®

ACTIVE PRINCIPLE:
etanercept

INDICATION:
Psoriasic arthritis
Psoriasis
Juvenile rheumatoid arthritis
Rheumatoid Arthritis
Ankylosing spondylitis

DATE:
23/06/2017

STATUS:
Authorized

MORE INFORMATION

Riximyo®

Riximyo®

ACTIVE PRINCIPLE:
rituximab

INDICATION:
Wegener's granulomatosis
microscopic polyangiitis
Rheumatoid Arthritis
Non-Hodgkin lymphoma

DATE:
15/06/2017

STATUS:
Authorized

MORE INFORMATION

Rixathon®

Rixathon®

ACTIVE PRINCIPLE:
rituximab

INDICATION:
Wegener's granulomatosis
microscopic polyangiitis
Rheumatoid Arthritis
Non-Hodgkin lymphoma
B-cell chronic lymphocytic leukemia

DATE:
15/06/2017

STATUS:
Authorized

MORE INFORMATION

Amgevita®

Amgevita®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile idiopathic arthritis
axial spondylitis
Psoriasic arthritis
Psoriasis
Pediatric plaque psoriasis
Hidradenitis suppurativa
Crohn's disease
Pediatric Crohn's disease
Ulcerative colitis
Uveitis
pediatric uveitis

DATE:
22/03/2017

STATUS:
Authorized

MORE INFORMATION

Truxima®

Truxima®

ACTIVE PRINCIPLE:
Rituximab

INDICATION:
Rheumatoid Arthritis
Non-Hodgkins lymphoma
Chronic lymphocytic leukemia
Granulomatosis with polyangiitis
microscopic polyangiitis

DATE:
17/02/2017

STATUS:
Authorized

MORE INFORMATION

Movymia®

Movymia®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
11/01/2017

STATUS:
Authorized

MORE INFORMATION

Earthy®

Earthy®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
04/01/2017

STATUS:
Authorized

MORE INFORMATION

inhixa®

inhixa®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
15/09/2016

STATUS:
Authorized

MORE INFORMATION

Flixabi®

Flixabi®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Psoriasic arthritis
Rheumatoid Arthritis
Psoriasis
Ulcerative colitis
Crohn's disease
Ankylosing spondylitis

DATE:
26/05/2016

STATUS:
Authorized

MORE INFORMATION

Benepali®

Benepali®

ACTIVE PRINCIPLE:
etanercept

INDICATION:
Psoriasic arthritis
Rheumatoid Arthritis
plaque psoriasis
Ankylosing spondylitis

DATE:
14/01/2016

STATUS:
Authorized

MORE INFORMATION

Accofil®

Accofil®

ACTIVE PRINCIPLE:
filgrastim

INDICATION:
neutropenia

DATE:
18/09/2014

STATUS:
Authorized

MORE INFORMATION

Abasaglar® (formerly Abasria®)

Abasaglar® (formerly Abasria®)

ACTIVE PRINCIPLE:
Insulin glargine

INDICATION:
Diabetes Mellitus

DATE:
09/09/2014

STATUS:
Authorized

MORE INFORMATION

Bemfola®

Bemfola®

ACTIVE PRINCIPLE:
follitropin alfa

INDICATION:
Anovulation

DATE:
27/03/2014

STATUS:
Authorized

MORE INFORMATION

Grastofil®

Grastofil®

ACTIVE PRINCIPLE:
filgrastim

INDICATION:
neutropenia

DATE:
18/10/2013

STATUS:
Authorized

MORE INFORMATION

Ovaleap®

Ovaleap®

ACTIVE PRINCIPLE:
follitropin alfa

INDICATION:
Anovulation

DATE:
27/09/2013

STATUS:
Authorized

MORE INFORMATION

Remsima®

Remsima®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Rheumatoid Arthritis
Crohn's disease
Ulcerative colitis
Ankylosing spondylitis
Psoriasic arthritis
Psoriasis

DATE:
10/09/2013

STATUS:
Authorized

MORE INFORMATION

Inflectra®

Inflectra®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Rheumatoid Arthritis
Crohn's disease
Ulcerative colitis
Ankylosing spondylitis
Psoriasic arthritis
Psoriasis

DATE:
10/09/2013

STATUS:
Authorized

MORE INFORMATION

Nivestim®

Nivestim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
08/06/2010

STATUS:
Authorized

MORE INFORMATION

Zarzio®

Zarzio®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
06/02/2009

STATUS:
Authorized

MORE INFORMATION

Filgastrim Hexal®

Filgastrim Hexal®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
hematopoietic stem cell transplantation

DATE:
06/02/2009

STATUS:
Authorized

MORE INFORMATION

Tevagastrim®

Tevagastrim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
15/09/2008

STATUS:
Authorized

MORE INFORMATION

Ratiogastrim®

Ratiogastrim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
15/09/2008

STATUS:
Authorized

MORE INFORMATION

Silapo®

Silapo®

ACTIVE PRINCIPLE:
Epoetin Zeta

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
18/12/2007

STATUS:
Authorized

MORE INFORMATION

Retacrit®

Retacrit®

ACTIVE PRINCIPLE:
Epoetin Zeta

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
18/12/2007

STATUS:
Authorized

MORE INFORMATION

Epoetin alfa Hexal®

Epoetin alfa Hexal®

ACTIVE PRINCIPLE:
epoetin alfa

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
28/08/2007

STATUS:
Authorized

MORE INFORMATION

Binocrit®

Binocrit®

ACTIVE PRINCIPLE:
epoetin alfa

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
28/08/2007

STATUS:
Authorized

MORE INFORMATION

Abseamed®

Abseamed®

ACTIVE PRINCIPLE:
epoetin alfa

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
28/08/2007

STATUS:
Authorized

MORE INFORMATION

Omnitrope®

Omnitrope®

ACTIVE PRINCIPLE:
Somatotropin

INDICATION:
Dwarfism
Prader-Willi syndrome
Turner syndrome

DATE:
12/04/2006

STATUS:
Authorized

MORE INFORMATION

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