Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-02-29 | colistimethate sodium | Forest Laboratories (USA) | treatment of cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P. aeruginosa. |
|
2012-03-02 | peginesatide | Takeda Pharmaceutical (Japan) | symptomatic anemia associated with chronic kidney disease (CKD) in adult patients on dialysis | |
2012-03-02 | desmoteplase | Lundbeck (Denmark) | acute ischaemic stroke
|
|
2014-11-12 | 190 micrograms fluocinolone acetonide intravitreal implant in applicator | Alimera Sciences (USA - GA) | chronic diabetic macular edema (DME) | Granting of a Market Authorisation in the EU |
2012-03-02 | EV-035 | Evolva (Switzerland) | ||
2012-03-07 | pre-pandemic influenza vaccine composed of purified, inactivated whole influenza virion | Baxter (USA) | active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known as bird or avian flu |
Positive opinion for the granting of a Market Authorisation in the EU |
2012-03-08 | Ragweed AIT | Merck&Co (USA) ALK (Denmark) | ragweed pollen induced allergic rhinitis (hay fever) |
|
2016-03-30 | defibrotide | Gentium (Italy), now Jazz Pharmaceuticals (Ireland) | severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem-cell transplantation |
Granting of a Market Authorisation in the US |
2012-03-15 | estradiol valerate and estradiol valerate/dienogest | Bayer (Germany) | heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive for contraception |
Granting of a Market Authorisation in the US |
2012-03-15 | agalsidase alfa | Shire (UK - USA) | Fabry disease |
Withdrawal of a market application in the US |
2017-06-27 | pirfenidone | Intermune (USA - CA) Genentech, a member of the Roche Group (USA - Switzerland) | mild to moderate idiopathic pulmonary fibrosis (IPF) | Granting of a Market Authorisation in the EU |
2014-11-11 | TH-302 | Threshold Pharmaceuticals (USA - CA) | previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS) |
Granting of a Fast Track status |
2012-03-21 | azelastine | Meda (Sweden) | allergic rhinitis | |
2012-03-26 | exenatide twice-daily | Eli Lilly (USA) | Byetta® is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these agents. | |
2013-01-23 | exon 45 specific phosphorothioate oligonucleotide | Prosensa Therapeutics (The Netherlands) | Duchenne muscular dystrophy |
Granting of the orphan status in the US |
2013-01-23 | exon 53 specific phosphorothioate oligonucleotide | Prosensa Therapeutics (The Netherlands) | Duchenne muscular dystrophy |
Granting of the orphan status in the US |
2012-03-26 | Pegylated recombinant factor VIII | Novo Nordisk (Denmark) | hemophilia A | |
2012-03-26 | halofuginone hydrobromide | Biological Consulting Europe Ltd (UK) | ||
2012-04-04 | heterologous human adult liver-derived stem cells | Fresenius Medical Care Deutschland GmbH (Germany) | acute liver failure | |
2012-03-26 | pomalidomide | Celgene Europe Limited (UK) | systemic sclerosis |
Granting of the orphan status in the EU |
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