|
Product name |
Active substance |
Therapeutic area |
Authorization date |
Manufacturer/Company name |
|
Abasaglar (previously Abasria) |
insulin |
Diabetes |
9 Sep 2014 |
Eli Lilly/Boehringer |
|
Abseamed |
epoetin alfa |
Anaemia |
28 Aug 2007 |
Medice Arzneimittel Pütter |
|
Accofil |
filgrastim |
Neutropenia |
18 Sep 2014 |
Accord Healthcare |
|
Amgevita |
adalimumab |
Ankylosing spondylitis |
22 Mar 2017 |
Amgen |
|
Benepali |
etanercept |
Axial spondyloarthritis |
14 Jan 2016 |
Samsung Bioepis |
|
Bemfola |
follitropin alfa |
Anovulation (IVF) |
24 Mar 2014 |
Finox Biotech |
|
Binocrit |
epoetin alfa |
Anaemia |
28 Aug 2007 |
Sandoz |
|
Biograstim |
filgrastim |
Cancer |
15 Sep 2008 |
CT Arzneimittel |
|
Blitzima |
rituximab |
Non-Hodgkin lymphoma |
13 Jul 2017 |
Celltrion |
|
Cyltezo |
adalimumab |
Crohn’s disease |
10 Nov 2017 |
Boehringer Ingelheim |
|
Epoetin alfa Hexal |
epoetin alfa |
Anaemia |
28 Aug 2007 |
Hexal |
|
Erelzi |
etanercept |
Ankylosing spondylitis |
27 Jun 2017 |
Sandoz |
|
Filgrastim Hexal |
filgrastim |
Cancer |
6 Feb 2009 |
Hexal |
|
Filgrastim ratiopharm |
filgrastim |
Cancer |
15 Sep 2008 |
Ratiopharm |
|
Flixabi |
infliximab |
Ankylosing spondylitis |
26 May 2016 |
Samsung Bioepis |
|
Grastofil |
filgrastim |
Neutropenia |
18 Oct 2013 |
Apotex |
|
Halimatoz |
adalimumab |
Ankylosing spondylitis |
CHMP positive opinion 1 Jun 2018 |
Sandoz |
|
Hefiya |
adalimumab |
Ankylosing spondylitis |
CHMP positive opinion 1 Jun 2018 |
Sandoz |
|
Hulio |
adalimumab |
Ankylosing spondylitis |
CHMP positive opinion 26 Jul 2018 |
Mylan/Fujifilm Kyowa Kirin Biologics |
|
Hyrimoz |
adalimumab |
Ankylosing spondylitis |
CHMP positive opinion 1 Jun 2018 |
Sandoz |
|
Herzuma |
trastuzumab |
Early breast cancer |
14 Feb 2018 |
Celltrion Healthcare |
|
Imraldi |
adalimumab |
Ankylosing spondylitis |
24 Aug 2017 |
Samsung Bioepis |
|
Inflectra |
infliximab |
Ankylosing spondylitis |
10 Sep 2013 |
Hospira |
|
Inhixa |
enoxaparin sodium |
Venous thromboembolism |
15 Sep 2016 |
Techdow Europe |
|
Insulin lispro Sanofi |
Insulin lispro |
Diabetes mellitus |
19 Jul 2017 |
Sanofi-Aventis |
|
Kanjinti |
trastuzumab |
Early breast cancer |
CHMP positive opinion 28 Mar 2018 |
Amgen/Allergan |
|
Lusduna |
insulin glargine |
Diabetes |
4 Jan 2017 |
Merck (MSD) |
|
Movymia |
teriparatide |
Osteoporosis |
11 Jan 2017 |
Stada Arzneimittel |
|
Mvasi |
bevacizumab |
Breast neoplasms Fallopian tube neoplasms |
15 Jan 2018 |
Amgen |
|
Nivestim |
filgrastim |
Cancer |
8 Jun 2010 |
Hospira (Pfizer) |
|
Omnitrope |
somatropin |
Pituitary dwarfism |
12 Apr 2006 |
Sandoz |
|
Ontruzant |
trastuzumab |
Early breast cancer |
15 Nov 2017 |
Samsung Bioepis |
|
Ovaleap |
follitropin alfa |
Anovulation (IVF) |
27 Sep 2013 |
Teva Pharma |
|
Pelgraz |
pegfilgrastim |
Neutropenia |
CHMP positive opinion 26 Jul 2018 |
Accord Healthcare |
|
Ratiograstim |
filgrastim |
Cancer |
15 Sep 2008 |
Ratiopharm |
|
Remsima |
infliximab |
Ankylosing spondylitis |
10 Sep 2013 |
Celltrion |
|
Retacrit |
epoetin zeta |
Anaemia |
18 Dec 2007 |
Hospira |
|
Ritemvia |
rituximab |
Wegener granulomatosis |
13 Jul 2017 |
Celltrion |
|
Rituzena (previously Tuxella) |
rituximab |
Wegener granulomatosis |
13 Jul 2017 |
Celltrion |
|
Rixathon |
rituximab |
Chronic B-cell lymphocytic leukaemia |
19 Jun 2017 |
Sandoz |
|
Riximyo |
rituximab |
Chronic B-cell lymphocytic leukaemia |
15 Jun 2017 |
Sandoz |
|
Semglee |
insulin glargine |
Diabetes |
28 Mar 2018 |
Mylan |
|
Silapo |
epoetin zeta |
Anaemia |
18 Dec 2007 |
Stada Arzneimittel |
|
Solymbic |
adalimumab |
Ankylosing spondylitis |
22 Mar 2017 |
Amgen |
|
Terrosa |
teriparatide |
Osteoporosis |
4 Jan 2017 |
Gedeon Richter |
|
Tevagrastim |
filgrastim |
Cancer |
15 Sep 2008 |
Teva Generics |
|
Thorinane |
enoxaparin sodium |
Venous thromboembolism |
15 Sep 2016 |
Pharmathen |
|
Trazimera |
trastuzumab |
Stomach Neoplasms |
CHMP positive opinion 1 Jun 2018 |
Pfizer |
|
Truxima |
rituximab |
Chronic lymphocytic leukaemia |
17 Feb 2017 |
Celltrion |
|
Udenyca |
pegfilgrastim |
neutropenia |
CHMP positive opinion 26 Jul 2018 |
ERA Consulting |
|
Valtropin |
somatropin |
Pituitary dwarfism |
24 Apr 2006 |
BioPartners |
|
Zessly |
infliximab |
Ankylosing spondylitis |
24 May 2018 |
Sandoz |
|
Zarzio |
filgrastim |
Cancer |
6 Feb 2009 |
Sandoz |
|
*Data collected on 12 May 2011, updated on 24 August 2018 |
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