Entresto Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

entresto

novartis europharm limited - sacubitril, valsartaanin - sydämen vajaatoiminta - angiotensiini ii-reseptorin salpaajat, muut yhdistelmät, agentit reniini-angiotensiini-järjestelmä - paediatric heart failureentresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. adult heart failureentresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Jalra Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

jalra

novartis europharm limited - vildagliptiini - diabetes mellitus, tyyppi 2 - dipeptidyl peptidase 4 (dpp-4) inhibitors, drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ja 5. 1 käytettävissä olevista tiedoista eri yhdistelmistä).

Neparvis Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

neparvis

novartis europharm limited - sacubitril, valsartaanin - sydämen vajaatoiminta - reniini-angiotensiinijärjestelmään vaikuttavat aineet - paediatric heart failureneparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5. adult heart failureneparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.

Revolade Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

revolade

novartis europharm limited - eltrombopag - purpura, trombosytopeeninen, idiopaattinen - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Silgard Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

silgard

merck sharp dohme ltd - ihmisen papilloomaviruksen tyypin 6 l1 proteiinia, ihmisen papilloomaviruksen tyypin 11 l1 proteiinia, ihmisen papilloomaviruksen tyypin 16 l1-proteiinia, ihmisen papilloomaviruksen tyypin 18 l1 proteiinia - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - rokotteet - silgard on rokote, jota käytetään ikä 9 vuotta ehkäisyyn:premaligneja genitaalialueen leesioita (kohdunkaulan, vulvan ja vaginan), premalignien anaali leesioita, kohdunkaulan syöpiä ja peräaukon syöpiä kausaalisesti tietyt onkogeeniset ihmisen papilloomavirus (hpv) types;sukuelinten visvasyyliä (condyloma acuminata) kausaalisesti tiettyjä hpv-tyyppejä. katso kohdat 4. 4 ja 5. 1 tärkeistä tiedoista, jotka tukevat tätä indikaatiota. silgardin käytön tulisi olla virallisten suositusten mukaisesti.

Arsenic trioxide Mylan Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

arsenic trioxide mylan

mylan ireland limited - arseenitrioksidi - leukemia, promyelocytic, akuutti - antineoplastiset aineet - arseenitrioksidi mylan on tarkoitettu induktio remission, ja konsolidointi aikuisilla potilailla, joilla on:- Äskettäin diagnosoitu alhainen, keskitason riski akuutti promyelosyyttinen leukemia (apl) (veren valkosolujen määrä, enintään 10 x 103/µl) yhdessä all-trans retinoiinihappo (atra)- oli uusiutunut/vaikeahoitoinen akuutti promyelosyyttinen leukemia (apl) (aiempi hoito olisi pitänyt sisällyttää retinoidi ja kemoterapia)ominaista läsnäolo t(15;17) translokaatio-ja/tai läsnäolo promyelosyyttinen leukemia/retinoic acid receptor alpha (pml/rar-alpha) geeni. vastausprosentti muita akuutin myelooisen leukemian alatyyppien mukaan arseenitrioksidi ei ole beenexamined.

Kirsty (previously Kixelle) Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

kirsty (previously kixelle)

biosimilar collaborations ireland limited - insuliini aspart - diabetes mellitus - diabeetilla käytettävät lääkkeet - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Darunavir Mylan Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

darunavir mylan

mylan pharmaceuticals limited - darunaviiria - hiv-infektiot - antiviraalit systeemiseen käyttöön - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):hoitoon hiv-1-infektio antiretroviraalisen hoidon (art)-kokenut aikuisille potilaille, mukaan lukien ne, jotka ovat olleet erittäin esikäsitelty. hoitoon hiv-1-infektion hoitoon lapsipotilailla, alkaen 3-vuotiaiden ja vähintään 15 kg kehon paino. päättäessään aloittaa hoitoa darunaviirin ja pieniannoksisen ritonaviirin kanssa, erityistä huomiota olisi kiinnitettävä hoidon historia potilaan ja malleja liittyviä mutaatioita eri aineet. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 ja 5. darunaviirin ja pieniannoksisen ritonaviirin kanssa on tarkoitettu yhdessä muiden antiretroviraalisten lääkkeiden hoitoon potilailla, joilla on ihmisen immuunikatovirus (hiv-1) hoitoon.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. päättäessään aloittaa hoitoa darunaviirin kanssa niin taiteen saaneilla potilailla todettiin testaus olisi oppaan käytön darunaviiri (ks. kohdat 4. 2, 4. 3, 4. 4 ja 5.

Eucreas Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

eucreas

novartis europharm limited - vildagliptiini, metformiinihydrokloridia - diabetes mellitus, tyyppi 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Galvus Liên Minh Châu Âu - Tiếng Phần Lan - EMA (European Medicines Agency)

galvus

novartis europharm limited - vildagliptiini - diabetes mellitus, tyyppi 2 - diabeetilla käytettävät lääkkeet - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.