Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

accord healthcare s.l.u. - docetaxel - head and neck neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, prostatic neoplasms, breast neoplasms - antineoplastic agents, - breast cancerdocetaxel accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

Եվրոպական Միություն - անգլերեն - 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.

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

mylan s.a.s. - rasagiline tartrate - parkinson disease - anti-parkinson drugs - rasagiline mylan is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Եվրոպական Միություն - անգլերեն - 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.

Եվրոպական Միություն - անգլերեն - 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.

Եվրոպական Միություն - անգլերեն - 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.

Մալթա - անգլերեն - Medicines Authority

apta medica internacional d.o.o likozarjeva ulica 6, 1000 ljubljana, , slovenia - amoxicillin, clavulanic acid - powder for solution for infusion or injection - amoxicillin 1000 mg clavulanic acid 200 mg - antibacterials for systemic use

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

rowex ltd - zoledronic acid - concentrate for solution for infusion - 4 mg/5 millilitre(s) - bisphosphonates; zoledronic acid

Մալայզիա - անգլերեն - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; glucose monohydrate, ph eur; sodium chloride (nacl); sodium lactate (50%) -

Մալայզիա - անգլերեն - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - magnesium chloride hexahydrate pheur; sodium lactate solution (50%); glucose monohydrate, ph eur; sodium chloride (nacl); calcium chloride dihydrate ph. eur. -