European Union - English - EMA (European Medicines Agency)

allergan pharmaceuticals ireland - bimatoprost, timolol - glaucoma, open-angle, ocular hypertension - ophthalmologicals, - reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

European Union - English - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

European Union - English - EMA (European Medicines Agency)

bayer ag - riociguat - hypertension, pulmonary - antihypertensives for pulmonary arterial hypertension - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah) adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - alpha1-proteinase inhibitor (human) - genetic diseases, inborn, lung diseases - antihemorrhagics, - respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes pizz, piz(null), pi(null,null), pisz). patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (fev1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 10 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf-i concentrations or was not tolerated.

Israel - English - Ministry of Health

bayer israel ltd - interferon beta 1b - powder and solvent for solution for injection - interferon beta 1b 0.3 mg/vial - interferon beta-1b - interferon beta-1b - use in ambulatory patients with relapsing-remitting multiple sclerosis (rrms) and relapsing progressive m.s. to reduce the frequency of clinical exacerbations. treatment of secondary progressive (sp) form of multiple sclerosis. treatment of patients who have experienced a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, including the prescence of mri abnormalities characteristic of m.s. and if they are determined to be at high risk of developing clinically definite multiple sclerosis.