Israel - English - Ministry of Health

pharmaswiss israel ltd - cyclobenzaprine hydrochloride 30 mg - capsules extended release - cyclobenzaprine - amrixal is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

jazz pharmaceuticals uk - defibrotide - solution for infusion - 80mg/1ml

European Union - English - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastic agents - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

European Union - English - EMA (European Medicines Agency)

bayer ag  - octocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor-viii deficiency).this preparation does not contain von willebrand factor and is therefore not indicated in von willebrand's disease.

European Union - English - EMA (European Medicines Agency)

bayer ag - octocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).iblias can be used for all age groups.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

European Union - English - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - prostatic hyperplasia - urologicals - treatment of the signs and symptoms of benign prostatic hyperplasia (bph).

European Union - English - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatitis, atopic - other dermatological preparations - treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human coagulation factor viii, human von willebrand factor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand disease (vwd)prophylaxis and treatment of haemorrhage or surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated.haemophilia a (congenital factor-viii deficiency)prophylaxis and treatment of bleeding in patients with haemophilia a.