Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2011-12-19 | fixed combination product consisting of dihydroartemisinin and piperaquine phosphate | Sigma Tau Industrie Farmaceutiche Riunite (Italy) | treatment of uncomplicated Plasmodium falciparum malaria |
Granting of a Market Authorisation in the EU |
2018-09-21 | icatibant - synthetic decapeptide | Shire (UK) | acute attacks of hereditary angioedema (HAE) in adult and paediatric patients | Granting of a Market Authorisation in Japan |
2011-12-19 | Sanofi Pasteur (France) | prevention of infection by influenza virus subtypes A and type B |
Granting of a patent | |
2011-12-19 | gadobutrol (1.0 molar macrocyclic gadolinium-based contrast agent) | Bayer HealthCare (Germany) | intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children age two and older to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system |
Granting of a Market Authorisation in the US |
2018-09-20 | fingolimod | Novartis (Switzerland) |
|
Positive opinion for the granting of a Market Authorisation in the EU |
2011-12-19 | trastuzumab | Roche (Switzerland) | HER2-positive early breast cancer in combination with adjuvant chemotherapy consisting of paclitaxel or docetaxel following adjuvant chemotherapy with doxorubicin and cyclophosphamide, or consisting of docetaxel and carboplatin. |
Granting of a Market Authorisation in the EU |
2011-12-19 | human normal immunoglobulin | CSL Behring (Australia) | replacement therapy in adults and children in primary immunodeficiency syndromes, and in myeloma or chronic lymphatic leukaemia patients with severe secondary hypogammaglobulinaemia and recurrent infections. | Granting of a Market Authorisation in the EU |
2011-12-20 | gabapentin enacarbil | GSK (UK) Xenoport (USA) | restless legs syndrome (RSL) |
Granting of a Market Authorisation in the US |
2012-03-02 | smallpox vaccine | Bavarian Nordic (Denmark) | smallpox infection prevention | |
2012-03-20 | indacaterol (QBAB149) | Novartis (Switzerland) | once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema | |
2011-12-20 | telaprevir | Vertex Pharmaceuticals (USA - MA) J&J (USA - NJ) | treatment of patients with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver) |
Granting of a Market Authorisation in the EU |
2011-12-20 | cabazitaxel | Sanofi (France) | combination with prednisone/prednisolone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. |
Granting of a Market Authorisation in the EU |
2011-12-20 | lumiracoxib | Novartis (Switzerland) | osteoarthritis of the knee and hip in patients who are non-carriers of the DQA1*0102 allele. |
Withdrawal of the product |
2011-12-20 | Kiovig® is a human normal immunoglobulin (IVIG), 10% solution indicated for replacement therapy in the treatment of Primary Immunodeficiency Syndromes, hypogammaglobulinemia and recurrent bacterial infections in patients with chronic lymphocytic leukemia and in plateau phase multiple myeloma patients and children and adolescents with congenital AIDS and recurrent bacterial infections. | Baxter (USA - IL) | multifocal motor neuropathy (extension of indication) |
Granting of a Market Authorisation in the EU |
2011-12-20 | rotigotine | Schwarz Pharma | symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults and idiopathic Parkinson's disease |
Granting of a Market Authorisation in the EU |
2015-06-25 | edoxaban | Daiichi Sankyo (Japan) | reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF) |
Granting of a Market Authorisation in the EU |
2011-12-20 | ranibizumab | Novartis (Switzerland) | visual impairment due to macular oedema secondary to retinal vein occlusion (extension of indications) |
Granting of a Market Authorisation in the EU |
2012-02-16 | Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | Novartis (Switzerland) | prevention of meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y | |
2011-10-12 | epoetin beta pegol | Chugai (Japan) Roche (Switzerland) | renal anemia | Granting of a Market Authorisation in Japan |
2017-11-09 | cladribine | Merck KGaA (Germany) | relapsing-remitting multiple sclerosis | Granting of a Market Authorisation in the EU |
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