Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - Önnur háþiýstingslækkandi - meðferð á lungnaslagæðaháþrýstingi (pah) til að bæta æfingargetu og einkenni hjá sjúklingum með who-virkni í flokki iii. verkun hefur verið sýnt fram á:aðal (sjálfvakin og ættingja) pah;pah efri að liðagigt án verulega millibils lungnasjúkdóm;pah tengslum með meðfædda almenn-til-í lungum shunts og eisenmenger er lífeðlisfræði. nokkrar endurbætur hafa líka verið sýnt fram í sjúklinga með pah sem hagnýtur ii. stayveer er einnig ætlað að fækka nýja stafræna sár í sjúklinga með almenna mænusigg og áframhaldandi stafræna-magasár.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoma - hinsveiflur og heilahimnubólur og hliðstæður - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - háþiýstingslækkandi - meðferð á lungnaslagæðaháþrýstingi (pah) til að bæta æfingargetu og einkenni hjá sjúklingum með who virkni iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. , nokkrar endurbætur hafa líka verið sýnt fram í sjúklinga með pah sem hagnýtur ii. tracleer er einnig ætlað að fækka nýja stafræna sár í sjúklinga með almenna mænusigg og áframhaldandi stafræna magasár.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - Æxlishemjandi lyf - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - hormón kynlíf og stillum kynfæri - oral contraceptive.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - hormón kynlíf og stillum kynfæri - getnaðarvörn til inntöku. 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - sykursýki, tegund 2 - lyf notuð við sykursýki - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , þrefaldur samsetning meðferð) sem viðbót til að fæði og æfing í sjúklingar ekki nægilega stjórn á eigin hámarks þolað skammt af sjúklingar og sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.