Норвегия - норвежки - Statens legemiddelverk

newbury pharmaceuticals ab - ikatibantacetat - injeksjonsvæske, oppløsning i ferdigfylt sprøyte - 30 mg

Европейски съюз - норвежки - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin dihydrochloride - phenylketonurias - andre alimentary tract and metabolism products, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Норвегия - норвежки - Statens legemiddelverk

accord healthcare b.v. - fesoterodinfumarat - depottablett - 8 mg

Европейски съюз - норвежки - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, type 2 - legemidler som brukes i diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated 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 diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Европейски съюз - норвежки - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, type 2 - legemidler som brukes i diabetes - vildagliptin/metformin hydrochloride accord 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 (see sections 4. 4, 4. 5 og 5. 1 for tilgjengelige data på forskjellige kombinasjoner).

Европейски съюз - норвежки - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastiske midler - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Европейски съюз - норвежки - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multippel sklerose, relapsing-remitting - immunosuppressants, selektiv immunosuppressants - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Норвегия - норвежки - Statens legemiddelverk

accord healthcare b.v. - midazolamhydroklorid - injeksjons-/infusjonsvæske, oppløsning i ferdigfylt sprøyte - 1 mg/ ml

Норвегия - норвежки - Statens legemiddelverk

newbury pharmaceuticals ab - sunitinibmalat - kapsel, hard - 50 mg

Норвегия - норвежки - Statens legemiddelverk

newbury pharmaceuticals ab - sunitinibmalat - kapsel, hard - 12.5 mg