Euroopan unioni - suomi - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumiini - yhteisön hankkimat infektiot - systeemiset bakteerilääkkeet, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 ja 5. on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft hylkääminen - immunosuppressantit - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Euroopan unioni - suomi - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - sukupuolihormonit ja genitaalijärjestelmään vaikuttavat aineet, - suullinen ehkäisy. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - abirateroniasetaatti - prostatiset kasvaimet - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Euroopan unioni - suomi - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripipratsolia - schizophrenia; bipolar disorder - psyykenlääkkeiden - abilify on tarkoitettu skitsofrenian hoitoon aikuisilla ja 15-vuotiailla ja sitä vanhemmilla nuorilla. abilify on tarkoitettu keskivaikeiden ja vaikeiden maniavaiheiden on tyypin i kaksisuuntainen mielialahäiriö, ja estämään uutta maniavaihetta aikuisilla, joilla on aiemmin ollut pääasiassa maniavaiheita jaksot ja joiden maaniset jaksot vastasi aripipratsoli hoito. abilify on tarkoitettu hoitoa enintään 12 viikkoa keskivaikeiden ja vaikeiden maniavaiheiden on tyypin i kaksisuuntainen mielialahäiriö nuorilla 13-vuotiaat ja sitä vanhemmat.

Euroopan unioni - suomi - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripipratsolia - skitsofrenia - psyykenlääkkeiden - skitsofrenian ylläpitohoito aikuisilla potilailla stabiloitui oraalisella aripipratsolilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belimumab - lupus erythematosus, systemaattinen - immunosuppressantit - benlysta on tarkoitettu lisälääkkeenä potilailla, iältään 5 vuotta ja vanhemmat, joilla on aktiivinen, autoantibody positiivinen systeeminen lupus erythematosus (sle) korkea taudin aktiivisuus (e. positiivinen anti-dsdna ja alhainen täydentää) huolimatta tavanomaista hoitoa. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Euroopan unioni - suomi - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimykoottiset aineet systeemiseen käyttöön - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Euroopan unioni - suomi - EMA (European Medicines Agency)

biogen netherlands b.v.  - fampridine - multippeliskleroosi - muut hermoston huumeet - fampyra on tarkoitettu parantamaan kävelyä aikuispotilailla, joilla on multippeliskleroosi ja kävelysairaus (laajennettu vammaisuuden tilan asteikko 4-7).