Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-06-24 | detection test of 21 mutations in the KRAS oncogene | Biocartis (Belgium) | colorectal cancer |
Granting of a Market Authorisation in the EU |
2016-01-14 | birch bark extract | Birken AG (Germany) | partial thickness wounds in adults |
Granting of a Market Authorisation in the EU |
2016-01-14 | asparaginase | Medac Gesellschaft fuer klinische Spezialpraeparate (Germany) | acute lymphoblastic leukaemia |
Granting of a Market Authorisation in the EU |
2015-11-19 | pitolisant | Bioprojet Pharma (France) | narcolepsy with or without cataplexy |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-11-19 | biosimilar insulin | Marvel Lifesciences (Russia) | diabetes |
Negative opinion for the granting of a Market Authorisation in the EU |
2015-11-19 | certolizumab pegol | UCB (Belgium) | severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX or other DMARDs |
Positive opinion for the granting of a Market Authorisation in the EU |
2018-06-22 | L-asparaginase loaded erythrocytes - eryaspase | Erytech Pharma (France) | acute lymphoblastic leukemia | Withdrawal of a market application in the EU |
2017-03-23 | adalimumab | Amgen (USA - CA) | moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older | Granting of a Market Authorisation in the EU |
2014-12-16 | lanreotide | Ipsen (France) | gastroenteropancreatic neuroendocrine tumors (GEP-NETs) |
Granting of a Market Authorisation in the US |
2015-11-24 | ambrisentan | GSK (UK) | pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III |
Granting of a Market Authorisation in the EU |
2014-04-28 | mercaptopurine | Nova Laboratories (UK) | acute lymphoblastic leukaemia |
Granting of a Market Authorisation in the US |
2018-10-19 | tetravalent dengue vaccine | Sanofi Pasteur (France) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-17 | ferric maltol | Iron Therapeutics (UK) Shield Therapeutics (UK) | iron deficiency anaemia in adults with inflammatory bowel disease |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-17 | diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type B conjugate vaccine (adsorbed) | Sanofi Pasteur (France) | prophylaxis against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib), in infants and toddlers from the age of 6 weeks |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-17 | ramucirumab with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) | Eli Lilly (USA -IN) | adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-17 | romiplostim | Amgen (USA - CA) | chronic immune (idiopathic) thrombocytopenic purpura (ITP) |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-15 | sugammadex | Merck&Co (USA - NJ) | reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide |
Granting of a Market Authorisation in the US |
2016-07-22 | grazoprevir/elbasvir | Merck&Co (USA - NJ) | chronic hepatitis C virus genotypes 1 and 4 infections in adult patients |
Granting of a Market Authorisation in the EU |
2017-01-17 | iGlarLixi (single injection Lyxumia® (lixisenatide) /Lantus® (insulin glargin) combination product) | Sanofi (France) Zealand Pharma (Denmark) | type 2 diabetes | Granting of a Market Authorisation in the EU |
2015-12-25 | sublingual immunotherapy tablet (SLIT-tablet) | ALK Abello (Denmark) Torii Pharmaceutical (Japan) | allergic rhinitis (hay fever) |
Submission of an NDA |
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