Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-03-06 | belatacept | BMS (USA) | intended in combination with corticosteroids and a mycophenolic acid for prophylaxis of graft rejection in adults receiving a renal transplant | |
2015-05-20 | omigapil | Santhera Pharmaceuticals (Switzerland) | congenital muscular dystrophies resulting from laminin-alpha-2 deficiency as in the MDC1A form of congenital muscular dystrophy |
Granting of a Fast Track status |
2011-12-20 | clobazam | Lundbeck (Denmark) | seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older |
Granting of a Market Authorisation in the USA |
2011-12-20 | briakinumab | Abbott (USA) | moderate to severe chronic plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA |
Withdrawal of the product |
2011-12-20 | dexamethasone | Allergan Pharmaceuticals (USA - CA) | treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis |
Granting of a Market Authorisation in the EU |
2011-12-20 | clopidogrel | BMS (USA) Sanofi (France) | Acute Coronary Syndrome |
Granting of a Market Authorisation in the USA |
2011-12-21 | dabigatran | Boehringer Ingelheim International (Germany) | prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation | |
2011-12-20 | seasonal vaccine composed of purified, inactivated split influenza virions | Baxter (USA - IL) | influenza |
Granting of a Market Authorisation in the EU |
2011-12-28 | aliskiren/amlodipine | Novartis (Switzerland) | essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone | |
2016-05-26 | teduglutide (recombinant analog of human glucagon-like peptide 2) | NPS Pharmaceuticals (USA - NJ) now Shire (UK - USA) | short bowel syndrome | Granting of a Market Authorisation in the EU |
2016-04-07 | recombinant human C1 inhibitor - conestat alfa | Pharming (The Netherlands), Santarus, now Salix Pharmaceuticals (USA - NC) | acute attacks of Hereditary Angioedema (HAE) hereditary angioedema attacks in adolescents with HAE |
Granting of a Market Authorisation in the EU |
2018-09-20 | tocilizumab | Roche (Switzerland) Genentech (USA - CA) | systemic juvenile idiopathic arthritis (SJIA) | Positive opinion for the granting of a Market Authorisation in the EU |
2011-12-20 | lanreotide | Ipsen (France) | acromegaly |
Granting of a patent |
2011-12-28 | aliskiren/hydrochlorothiazide | Novartis(Switzerland) | treatment of adult patients with essential hypertension | |
2011-12-20 | sunitinib | Pfizer (USA - NY) | progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic) |
Granting of a patent |
2017-06-27 | pneumococcal polysaccharide conjugate vaccine (absorbed) | GSK Biologicals (UK - Belgium) | active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age prevention of invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) | Positive opinion for the granting of a Market Authorisation in the EU |
2011-12-20 | alfataliglicerase (plant-cell expressed form of glucocerebrosidase) | Protalix (Israel) Pfizer (USA - NY) | type 1 Gaucher disease |
Granting of a Market Authorisation in the US |
2011-12-20 | tesamorelin | Theratechnologies (Canada) Ferrer Internacional (Spain) | treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy |
Withdrawal of a market application in the EU |
2012-02-21 | vandenatib | AstraZeneca (UK) | medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease |
Granting of a Market Authorisation in the EU |
2017-06-29 | panitumumab | Amgen (USA - CA) | adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
• in first-line in combination with FOLFOX
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
|
Granting of a Market Authorisation in the US |
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