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.

Ireland - English - HPRA (Health Products Regulatory Authority)

leo pharma a/s - protamine sulphate - solution for injection/infusion - 1400 international unit(s)/millilitre - antidotes; protamine

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

kent pharma (uk) ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 30microgram

Malta - English - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - protamine sulfate - solution for injection/infusion - protamine sulfate 10 mg/ml - all other therapeutic products

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - other alimentary tract and metabolism products, - elaprase is indicated for the long-term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii). heterozygous females were not studied in the clinical trials.

European Union - English - EMA (European Medicines Agency)

advanz pharma limited - obeticholic acid - liver cirrhosis, biliary - bile and liver therapy - ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

European Union - English - EMA (European Medicines Agency)

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - other antianemic preparations - rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (ckd).the diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).

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

advanz pharma - cyclizine hydrochloride - oral tablet - 50mg

Israel - English - Ministry of Health

pharma shalom - aluminium hydroxide; magnesium hydroxide; simethicone - suspension - aluminium hydroxide 175 mg / 5 ml; magnesium hydroxide 200 mg / 5 ml; simethicone 25 mg / 5 ml - antacid, antiflatulent, relief of sensation of heatburn.

European Union - English - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - all other therapeutic products - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.