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欧州で承認済みで日本で未承認の医薬品について
| No. | 国名 | 有効成分名 | 企業名 | 承認日 | 効能・効果 | 調査日 |
|---|---|---|---|---|---|---|
| 1 | EU | catumaxomab | Fresenius Biotech GmbH | 2009/4/20 | [1]Removab 10 microgram concentrate for solution for infusion Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. [2]Removab 50 microgram concentrate for solution for infusion Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. |
2012/10/5 |
| 2 | EU | eslicarbazepine acetate | BIAL - Portela & Ca, S.A. | 2009/4/21 | [1]Zebinix 200 mg tablets Zebinix is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. [2]Zebinix 400 mg tablets Zebinix is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. [3]Zebinix 600 mg tablets Zebinix is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. [4]Zebinix 800 mg tablets Zebinix is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. |
2013/9/25 |
| 3 | EU | ulipristal | Laboratoire HRA Pharma | 2009/5/15 | Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. | 2012/9/11 |
| 4 | EU | plerixafor | Genzyme Europe B.V. | 2009/7/31 | Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly (see section 4.2). | 2012/12/25 |
| 5 | EU | vinflunine | Pierre Fabre Médicament | 2009/9/21 | Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen Efficacy and safety of vinflunine have not been studied in patients with Performance Status ≥ 2. |
2013/1/8 |
| 6 | EU | aztreonam lysine*II) | Gilead Sciences International Limited | 2009/9/21 | Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
2012/12/14 |
| 7 | EU | characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins | TiGenix NV | 2009/10/5 | Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomized controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1-5cm². | 2012/10/9 |
| 8 | EU | prucalopride | Movetis NV | 2009/10/15 | [1]Resolor 1 mg film-coated tablets. Resolor is indicated for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. [2]Resolor 2 mg film-coated tablets Resolor is indicated for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. |
2012/10/4 |
| 9 | EU | rilonacept*Ⅰ） | Regeneron UK Limited | 2009/10/23 | Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. | 2012/10/1 |
| 10 | EU | epoetin theta | ratiopharm GmbH | 2009/10/29 | [1] Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. [2]Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. [3]Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. [4]Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. [5]Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. [6]Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. ⑦Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. ⑧Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe - Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. |
2012/9/27 |
| 11 | EU | dronedarone | sanofi-aventis | 2009/11/26 | MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile (see sections 4.3 and 4.4), Multaq should only be prescribed after alternative treatment options have been considered. MULTAQ should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure. |
2012/9/13 |
| 12 | EU | amifampridine | BioMarin Europe Ltd | 2009/12/23 | Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. | 2012/12/12 |
| 13 | EU | besilesomab | CIS bio international | 2010/1/11 | This medicinal product is for diagnostic use only. Scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection |
2012/10/12 |
| 14 | EU | corifollitropin alfa | N.V. Organon | 2010/1/25 | [1]Elonva 100 micrograms solution for injection. Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. [2]Elonva 150 micrograms solution for injection. Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. |
2012/9/28 |
| 15 | EU | roflumilast | Takeda GmbH | 2010/7/5 | Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. | 2012/9/7 |
| 16 | EU | velaglucerase alfa | Shire Pharmaceuticals Ireland Ltd. |
2010/8/26 | [1]VPRIV 200 Units powder for solution for infusion VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. [2]VPRIV 400 Units powder for solution for infusion VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. |
2012/9/11 |
| 17 | EU | asenapine maleate | N.V. Organon | 2010/9/1 | [1]Sycrest 5 mg sublingual tablets Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. [2]Sycrest 10 mg sublingual tablets Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. |
2012/9/13 |
| 18 | EU | vernakalant hydrochloride | Merck Sharp & Dohme Ltd. | 2010/9/1 | Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults -For non-surgery patients: atrial fibrillation ≤ 7 days duration -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration |
2012/10/9 |
| 19 | EU | regadenoson | Rapidscan Pharma Solutions EU Ltd. |
2010/9/6 | This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress. |
2012/9/26 |
| 20 | EU | conestat alfa | Pharming Group N.V. | 2010/10/28 | Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. | 2012/9/25 |
| 21 | EU | ticagrelor | AstraZeneca AB | 2010/12/3 | Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (unstable angina, non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). For further information, please refer to section 5.1. |
2012/9/5 |
| 22 | EU | collagenase Clostridium histolyticum | Auxilium UK Limited | 2011/2/28 | Xiapex is indicated for the treatment of Dupuytren’s contracture in adult patients with a palpable cord. | 2012/9/6 |
| 23 | EU | cabazitaxel | sanofi-aventis groupe |
2011/3/17 | JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1). | 2012/9/11 |
| 24 | EU | retigabine | Glaxo Group Ltd. |
2011/3/28 | [1]Trobalt 50 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. [2]Trobalt 100 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. [3]Trobalt 200 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. [4]Trobalt 300 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. [5]Trobalt 400 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. [6]Treatment initiation pack Trobalt 50 mg film-coated tablets Trobalt 100 mg film-coated tablets Trobalt is indicated as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. |
2012/9/7 |
| 25 | EU | belatacept | Bristol-Myers Squibb Pharma EEIG | 2011/6/17 | NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function). It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen. |
2012/9/5 |
| 26 | EU | ipilimumab | Bristol-Myers Squibb Pharma EEIG | 2011/7/13 | YERVOY is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. |
2012/9/5 |
| 27 | EU | belimumab | Glaxo Group Ltd. | 2011/7/13 | [1]Benlysta 120 mg powder for concentrate for solution for infusion. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g positive anti-dsDNA and low complement) despite standard therapy (see section 5.1). [2]Benlysta 400 mg powder for concentrate for solution for infusion. Benlysta is indicated as add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy (see section 5.1). |
2012/9/11 |
| 28 | EU | boceprevir | Merck Sharp & Dohme Ltd. | 2011/7/18 | Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.See sections 4.4 and 5.1. |
2012/9/7 |
| 29 | EU | fampridine | Biogen Idec Ltd. |
2011/7/20 | Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). |
2012/9/5 |
| 30 | EU | telavancin*Ⅰ） | Theravance UK Limited | 2011/9/2 | [1]VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. [2]VIBATIV 750 mg powder for concentrate for solution for infusion VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
2012/9/6 |
| 31 | EU | abiraterone acetate | Janssen-Cilag International N.V. | 2011/9/5 | ZYTIGA is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. | 2012/8/31 |
| 32 | EU | piperaquine tetraphosphate / dihydroartemisinin | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | 2011/10/27 | [1]Eurartesim 160 mg/20 mg film-coated tablets Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults,children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial agents. [2]Eurartesim 320 mg/40 mg film-coated tablets Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults,children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial agents. |
2012/9/24 |
| 33 | EU | emtricitabine / rilpivirine hydrochloride /tenofovir disoproxil fumarate | Gilead Sciences International Ltd. |
2011/11/28 | Eviplera is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml. The demonstration of the benefit of the combination emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate in antiretroviral therapy is based on week 48 safety and efficacy analyses from two randomised, double-blind, controlled Phase III studies in treatment-naïve patients (see section 5.1). As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Eviplera (see sections 4.4 and 5.1). |
2012/8/31 |
| 34 | EU | fidaxomicin | Astellas Pharma Europe BV | 2011/12/5 | DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1). Consideration should be given to official guidelines on the appropriate use of antibacterial agents. |
2012/9/3 |
| 35 | EU | azilsartan medoxomil*II) | Takeda Global Research and Development Centre (Europe) Ltd. | 2011/12/7 | [1]Edarbi 20 mg tablets Edarbi is indicated for the treatment of essential hypertension in adults. [2]Edarbi 40 mg tablets Edarbi is indicated for the treatment of essential hypertension in adults. [3]Edarbi 80 mg tablets Edarbi is indicated for the treatment of essential hypertension in adults. |
2012/9/3 |
| 36 | EU | vandetanib | AstraZeneca AB | 2012/2/17 | [1]Caprelsa 100 mg film-coated tablets. Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1). [2]Caprelsa 300 mg film-coated tablets. Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer(MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1). |
2012/8/30 |
| 37 | EU | vemurafenib | Roche Registration Ltd. | 2012/2/17 | Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1). | 2012/8/30 |
| 38 | EU | pasireotide diaspartate | Novartis Europharm Ltd. | 2012/4/24 | [1]Signifor 0.3 mg solution for injection Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. [2]Signifor 0.6 mg solution for injection Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. [3]Signifor 0.9 mg solution for injection Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. |
2012/11/5 |
| 39 | EU | pixantrone dimaleate | CTI Life Sciences Ltd. | 2012/5/10 | Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. | 2012/11/5 |
| 40 | EU | ferumoxytol | Takeda Global Research and Development Centre (Europe) Ltd. | 2012/6/15 | Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2). |
2012/11/5 |
| 41 | EU | aclidinium bromide, micronised | Almirall, S.A. | 2012/7/20 | Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). | 2013/2/7 |
| 42 | EU | ivacaftor | Vertex Pharmaceuticals (U.K.) Ltd. | 2012/7/23 | Kalydeco is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene (see sections 4.4 and 5.1). | 2012/11/5 |
| 43 | EU | perampanel | Eisai Europe Ltd. | 2012/7/23 | [1] Fycompa 2 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. [2]Fycompa 4 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. [3]Fycompa 6 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. [4]Fycompa 8 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. [5]Fycompa 10 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. [6]Fycompa 12 mg film-coated tablets Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. |
2012/11/5 |
| 44 | EU | copper (64Cu) chloride | Sparkle S.r.l | 2012/8/23 | Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. | 2012/11/5 |
| 45 | EU | ceftaroline fosamil | AstraZeneca AB | 2012/8/23 | Zinforo is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Complicated skin and soft tissue infections (cSSTI) • Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
2012/11/5 |
| 46 | EU | ruxolitinib (as phosphate) | Novartis Europharm Ltd. | 2012/8/23 | [1] Jakavi 5 mg tablets Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. [2]Jakavi 15 mg tablets Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. [3]Jakavi 20 mg tablets Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. |
2012/11/5 |
| 47 | EU | teduglutide | Nycomed Danmark ApS | 2012/8/30 | Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery. | 2012/11/5 |
| 48 | EU | catridecacog | Novo Nordisk A/S | 2012/9/3 | Long term prophylactic treatment of bleeding in patients 6 years and above with congenital factor XIII A-subunit deficiency. |
2012/11/5 |
| 49 | EU | decitabine | Janssen-Cilag International N V | 2012/9/20 | Dacogen is indicated for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy. | 2012/11/5 |
| 50 | EU | brentuximab vedotin | Takeda Global Research and Development Centre (Europe) Ltd. | 2012/10/25 | ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). |
2013/2/7 |
| 51 | EU | dapagliflozin propanediol monohydrate | Bristol-Myers Squibb / AstraZeneca EEIG | 2012/11/12 | [1]Forxiga 5 mg film-coated tablets Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). [2]Forxiga 10 mg film-coated tablets Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). |
2013/2/7 |
| 52 | EU | ingenol mebutate | LEO Pharma A/S | 2012/11/15 | [1]Picato 150 micrograms/gram gel Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. [2]Picato 500 micrograms/gram gel Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. |
2013/2/7 |
| 53 | EU | linaclotide | Almirall, S.A. | 2012/11/26 | Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults. | 2013/2/7 |
| 54 | EU | pegloticase | Savient Pharma Ireland Ltd. | 2013/1/8 | KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adul tpatients who may also have erosive joint involvement and who have failed to ormalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4). The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4). |
2013/5/13 |
| 55 | EU | florbetapir (18F) | Eli Lilly Nederland B.V. | 2013/1/14 | [1]Amyvid 800 MBq/mL solution for injection This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1. [2]Amyvid 1900 MBq/mL solution for injection This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1. |
2013/5/13 |
| 56 | EU | nalmefene hydrochloride dihydrate | H. Lundbeck A/S | 2013/2/25 | Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [see section 5.1], without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment. |
2013/5/15 |
| 57 | EU | ocriplasmin | ThromboGenics NV | 2013/3/13 | JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns (see section 5.1). | 2013/5/16 |
| 58 | EU | bosutinib (as monohydrate) | Pfizer Ltd | 2013/3/27 | [1]Bosulif 100 mg film-coated tablets Bosulif is indicated for the treatment of adult patients with chronic phase (CP), accelerated phase(AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. [2]Bosulif 500 mg film-coated tablets Bosulif is indicated for the treatment of adult patients with chronic phase (CP), accelerated phase(AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. |
2013/5/16 |
| 59 | EU | avanafil | Vivus BV | 2013/6/21 | [1]Spedra 50 mg tablets Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. [2]Spedra 100 mg tablets Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. [3]Spedra 200 mg tablets Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. |
2013/7/12 |
| 60 | EU | enzalutamide | Astellas Pharma Europe B.V. | 2013/6/21 | Xtandi is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. | 2013/7/16 |
| 61 | EU | ponatinib | Ariad Pharma Ltd | 2013/7/1 | [1] Iclusig 15 mg film-coated tablets Iclusig is indicated in adult patients with •chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation •Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. [2]Iclusig 45 mg film-coated tablets Iclusig is indicated in adult patients with •chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation •Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. |
2013/8/26 |
| 62 | EU | vismodegib | Roche Registration Ltd | 2013/7/12 | Erivedge is indicated for the treatment of adult patients with: • symptomatic metastatic basal cell carcinoma • locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1). |
2013/8/27 |
EMA＿HPにあるEuropean public assessment reports等よりNew Active Substance (NAS）として承認されたもの（ワクチンを除く）のうち、日本で2013年5月31日時点で未承認のものを掲載した。（引き続き調査中）
注１）データは調査時の情報に基づき記載している。
注２）マーカーは米国および欧州の未承認薬一覧のうち、米国と欧州で有効成分名が同じ医薬品。
*I）現在販売されていない。
*II）類似医薬品が日本で承認されている。
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