HPE HPE Fresenius Kabi handbook | Page 21

Product name INN/active substance Therapeutic area Marketing authorisation
holder Marketing authorisation
date
Blitzima Rituximab Non-Hodgkin lymphoma,
chronic B-cell lymphocytic
leukaemia Celltrion 13/07/2017
Ritemvia Rituxumab Wegener granulomatosis,
microscopic polyangiitis,
non-Hodgkin lymphoma Celltrion 13/07/2017
Rituzena
(previously Tuxella) Rituxumab Wegener granulomatosis,
microscopic polyangiitism
non-Hodgkin lymphoma,
chronic B-cell lymphocytic
leukaemia Celltrion 13/07/2017
Insulin lispro Sanofi Insulin lispro Diabetes mellitus Sanofi Aventis 19/07/2017
Imraldi Adalimumab Ankylosing spondylitis,
arthritis, Crohn’s disease,
hidradenitis suppurativa,
psoriatic arthritis,
psoriasis, rheumatoid
arthritis, ulcerative colitis,
uveitis Samsung Bioepis 24/08/2017
Cyltezo Adalimumab Crohn’s disease,
hidradenitis suppurativa,
juvenile idiopathic
arthritis, psoriasis,
psoriatic arthritis,
rheumatoid arthritis,
ulcerative colitis, uveitis Boehringer Ingelheim 10/11/2017
Ontruzant Trastuzumab Early breast cancer,
metastatic breast cancer,
metastatic gastric cancer Samsung Bioepis 15/11/2017
Mvasi Bevacizumab Breast neoplasms,
fallopian tube neoplasms,
non-small-cell lung
carcinoma, ovarian
neoplasms, peritoneal
neoplasms, renal cell
carcinoma Amgen 15/01/2018
Herzuma Trastuzumab Early breast cancer,
metastatic breast cancer,
metastatic gastric cancer Celltrion Healthcare 09/02/2018
Semglee Insulin glargine Diabetes mellitus Mylan 28/03/2018
Kanjinti Trastuzumab Early breast cancer,
metastatic breast cancer,
metastatic gastric cancer Amgen 16/05/2018
Zessly Infliximab Ankylosing spondylitis,
Crohn’s disease, psoriatic
arthritis, psoriasis,
rheumatoid arthritis,
ulcerative colitis Sandoz 18/05/2018
Halimatoz Adalimumab Ankylosing spondylitis,
hidradenitis suppurativa,
juvenile rheumatoid
arthritis, psoriatic arthritis,
psoriasis, rheumatoid
arthritis, uveitis Sandoz 26/07/2018
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