Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-07-24 | vatreptacog alfa (activated) | Novo Nordisk (Denmark) | hemophilia A | |
2012-07-24 | vatreptacog alfa (activated) | Novo Nordisk (Denmark) | hemophilia B | |
2012-07-24 | aclidinium bromide inhalation powder | Almirall (Spain) Forest Laboratories (USA) | long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema | |
2015-04-23 | dasiprotimut-T Biovest | Biovest International (USA) | non-Hodgkin’s follicular lymphoma |
Negative opinion for the granting of a Market Authorisation in the EU |
2013-09-02 | dabrafenib | Novartis (Switzerland) |
|
Granting of a Market Authorisation in the EU |
2014-06-30 | trametinib | Novartis (Switzerland) |
|
Granting of a Market Authorisation in the EU |
2012-08-14 | ranibizumab | Novartis (Switzerland) | diabetic macular edema (DME) |
Granting of a Market Authorisation in the US |
2012-08-17 | DasKloster 1001 | Mondobiotech (Switzerland) | idiopathic pulmonary fibrosis (IPF) | |
2012-08-19 | AQP-182 | Aquapharm Biodiscovery (UK) | infectious diseases | |
2012-08-22 | DasKloster 0210 | Mondobiotech (Switzerland) | chronic beryllium disease (chronic, allergic-type, occupational lung disease caused by exposure to the metal Beryllium) | |
2012-08-29 | RPL554 | Verona Pharma (UK) | chronic obstructive airways disease such as COPD (chronic obstructive pulmonary disease) and asthma with bronchodilator and anti-inflammatory effects | |
2012-08-29 | imiquimod | Meda (Sweden) | actinic keratosis | |
2012-08-29 | gevokizumab | Xoma (USA - CA) Servier (France) | non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis |
Granting of the orphan status in the EU |
2014-12-23 | tbo-filgrastim | Teva Pharmaceuticals (Israel) | neutropenia |
Granting of a Market Authorisation in the US |
2012-08-30 | everolimus | Novartis (Switzerland) | subependymal giant cell astrocytoma (SEGA) | Granting of a Market Authorisation in the US |
2012-08-31 | PLX cells (PLacental eXpanded cells) | Pluristem Therapeutics (Israel) | aplastic anemia | |
2012-08-31 | bedaquiline | Janssen-Cilag International - a J&J company (USA) | combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults |
Granting of a patent |
2012-09-04 | lurbinectidin | PharmaMar (Spain) | ovarian cancer | Granting of the orphan status in the EU |
2017-12-19 | bosutinib | Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the US |
2014-12-19 | recombinant factor IX (rFIX - nonacog gamma) | Baxter (USA - IL) | treatment and prophylaxis of bleeding episodes for patients over 16 years of age with hemophilia B routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B |
Granting of a Market Authorisation in the EU |
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