유럽 연합 - 영어 - EMA (European Medicines Agency)

recordati rare diseases - pasireotide - acromegaly; pituitary acth hypersecretion - pituitary and hypothalamic hormones and analogues - 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.signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.

유럽 연합 - 영어 - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drugs used in diabetes - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(see sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

유럽 연합 - 영어 - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitis c, chronic - antivirals for systemic use - olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult patients.for hepatitis c virus (hcv) genotype specific activity.

유럽 연합 - 영어 - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - carcinoma, non-small-cell lung - other antineoplastic agents, protein kinase inhibitors - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations.- the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations.- the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations.- the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

유럽 연합 - 영어 - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:•    in patients insufficiently controlled on their maximally tolerated dose of metformin alone •    in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products•    in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.for study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

유럽 연합 - 영어 - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, type 2 - drugs used in diabetes - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

유럽 연합 - 영어 - EMA (European Medicines Agency)

pfizer europe ma eeig - palonosetron hydrochloride - nausea; vomiting; cancer - antiemetics and antinauseants, - palonosetron hospira is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy;the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.palonosetron hospira is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

유럽 연합 - 영어 - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetide hydrochloride - hyperparathyroidism, secondary - anti-parathyroid agents, calcium homeostasis - parsabiv is indicated for the treatment of secondary hyperparathyroidism (shpt) in adult patients with chronic kidney disease (ckd) on haemodialysis therapy.

유럽 연합 - 영어 - EMA (European Medicines Agency)

shionogi b.v. - ospemifene - postmenopause - sex hormones and modulators of the genital system, - senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (vva) in post-menopausal women.

유럽 연합 - 영어 - EMA (European Medicines Agency)

novartis europharm limited - travoprost - glaucoma, open-angle; ocular hypertension - ophthalmologicals - decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).