Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-11-15 | isavuconazonium sulfate | Basilea Pharmaceutica (Switzerland) Astellas Pharma (Japan) | mucormycosis | Product launch |
2014-07-20 | Precipitated and purified pertussis-diphtheria-tetanus-inactivated polio vaccine (Salk vaccine) vaccine | Daiichi Sankyo (Japan) Sanofi Pasteur (France) | prevention of pertussis, diphtheria, tetanus and poliomyelitis |
Granting of a Market Authorisation in Japan |
2018-07-30 | brexpiprazole - 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one | Lundbeck (Denmark) Otsuka Pharmaceutical (Japan) | schizophrenia | Granting of a Market Authorisation in the EU |
2016-04-29 | albuterol | Teva Pharmaceuticals (Israel) | treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease prevention of exercise-induced bronchospasm (EIB) in children 4 to 11 years of age |
Granting of a Market Authorisation in the US |
2014-07-20 | methotrexate | Medac Pharma (USA- IL) | rheumatoid arthritis (RA) polyarticular-course juvenile idiopathic arthritis (pJIA) psoriasis |
Granting of a Market Authorisation in the USA |
2014-07-20 | cryopreserved placental membrane | Osiris Therapeutics (USA - Md) | acute and chronic wounds |
Product launch |
2014-07-20 | Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation | Octapharma (Switzerland) | chronic Immune Thrombocytopenic Purpura (ITP) |
Granting of a Market Authorisation in the USA |
2014-07-23 | bevacizumab | Genentech (USA), a member of Roche Group (Switzerland) | recurrent platinum-resistant ovarian cancer | Granting of a Market Authorisation in the EU |
2014-07-25 | stented aortic bioprosthesis | Sorin (Italy) | aortic valve disease |
Product launch |
2015-10-23 | asfotase alfa | Alexion Pharmaceuticals (USA - CT) | hypophosphatasia | Granting of a Market Authorisation in the US |
2015-07-23 | Plasmodium falciparum and hepatitis B vaccine | GSK (UK) | malaria hepatitis B |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-12-17 | dexamethasone | Laboratories CTRS (France) | multiple myeloma |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-07-27 | single stranded, chemically modified oligonucleotide that binds to and inhibits the function of micro RNA-21 | Regulus Therapeutics (USA - CA) | Alport syndrome | Granting of a patent |
2017-12-21 | nivolumab | BMS (USA - NY) |
|
Granting of a Market Authorisation in the US |
2014-09-22 | filgrastim - biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF) | Accord Healthcare Ltd (UK) wholly owned subsidiary of Intas Pharmaceuticals (India) | - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) - reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia - mobilisation of peripheral blood progenitor cells (PBPCs) - severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ? 0.5 x 109/L, and a history of severe or recurrent infections - persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate |
Granting of a Market Authorisation in the EU |
2014-07-28 | entecavir | BMS (USA) | chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-07-29 | busulfan (1,4-butanediol, dimethanesulfonate) | Pierre Fabre Médicament (France) | conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-07-29 | anidulafungin (1-[(4R,5R)-4,5-dihydroxy-N2-[[4\ | Pfizer (USA -NY) | invasive candidiasis in adult patients |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-07-29 | adalimumab | Abbvie (USA - IL) | active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy |
Positive opinion for the granting of a Market Authorisation in the EU |
2014-09-08 | tocilizumab | Roche (Switzerland) | severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate | Granting of a Market Authorisation in the EU |
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