Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2012-01-27 | interferon beta-1a | Merck KGaA (Germany) | early signs of multiple sclerosis | |
2012-02-03 | asparaginase Erwinia chrysanthemi | EUSA Pharma (USA) now Jazz Pharmaceuticals (USA) | treatment of patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL. |
Granting of a Market Authorisation in the US |
2011-12-20 | levonorgestrel (new low dose levonorgestrel releasing intrauterine system) | Bayer Healthcare (Germany) | long-term contraception |
Granting of a Market Authorisation in the US |
2011-12-18 | Dako (Denmark) | assessment of breast cancer patients for whom treatment with Herceptin® is being considered |
Granting of a Market Authorisation in the US | |
2011-12-19 | Argen-X (The Netherlands-Belgium) | Granting of a patent | ||
2011-12-19 | ticagrelor | AstraZeneca (UK) | reduction of heart attacks and cardiovascular death in patients with Acute Coronary Syndrome | Granting of a Market Authorisation in the US |
2017-09-15 | idebenone | Santhera Pharmaceuticals (Switzerland) | Duchenne Muscular Dystrophy and other muscular dystrophies | Negative opinion for the granting of a Market Authorisation in the EU |
2015-09-25 | insulin degludec | Novo Nordisk (Denmark) | type 1 and type 2 diabetes |
Granting of a Market Authorisation in the US |
2015-09-25 | insulin degludec-insulin aspart | Novo Nordisk (Denmark) | type 1 and type 2 diabetes |
Granting of a Market Authorisation in the US |
2018-06-28 | dexmedetomidine | Orion Corporation (Finland) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2011-12-19 | fidaxomicin | FGK Representative Service GmbH (Germany) | Clostridium difficile infections also known as C. difficile-associated diarrhoea |
Granting of a Market Authorisation in the EU |
2011-12-19 | azilsartan medoxomil | Takeda Pharmaceutical (Japan) | essential hypertension in adults |
Granting of a Market Authorisation in the EU |
2011-12-19 | fixed dose combination of emtricitabine, rilpivirine and tenofovir disoproxil | Gilead Sciences (USA) | HIV-1 infection |
Granting of a Market Authorisation in the EU |
2011-12-19 | nasally administered four-strain live attenuated influenza vaccine | AstraZeneca (UK) | prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age |
Granting of a Market Authorisation in the EU |
2017-05-09 | idebenone | Santhera Pharmaceuticals (Switzerland) | visual impairment in patients with Leber’s Hereditary Optic Neuropathy (LHON) | Product launch |
2011-11-24 | Combination of saxagliptin and metformin | BMS (USA) AstraZeneca (UK) | type 2 diabetes in combination with insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control |
Granting of a Market Authorisation in the EU |
2012-04-02 | mipomersen | Genzyme (USA - MA), a Sanofi company (France)/Isis Pharmaceuticals (USA - CA), now Ionis Pharmaceuticals (USA - CA) | homozygous (HoHF) and severe heterozygous familial hypercholesterolemia (HeFH) |
Refusal of a Market Authorisation in the EU |
2011-12-20 | mesalamine | Shire (UK - USA) | maintenance of remission in patients with ulcerative colitis |
Granting of a Market Authorisation in the US |
2011-12-20 | retigabine | GSK (UK) Valeant Pharmaceuticals (USA) | treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy. |
Granting of a Market Authorisation in the EU |
2012-01-12 | meningococcal and Hib combination vaccine | GSK (UK) | prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib) |
Refusal of a Market Authorisation in the US |
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