האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

alkaloid - int d.o.o - methadone hydrochloride - oral solution - 1/1 milligram(s)/millilitre - methadone

מלטה - אנגלית - Medicines Authority

alkaloid-int d.o.o. Šlandrova ulica 4, 1231 ljubljana-crnuce, slovenia - methadone hydrochloride - oral solution - methadone hydrochloride 1 mg/ml - other nervous system drugs

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

serb s.a., - midazolam - oromucosal solution - 10 milligram(s) - midazolam

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

serb s.a., - midazolam - oromucosal solution - midazolam

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

serb s.a., - midazolam - oromucosal solution - midazolam

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

serb s.a., - midazolam - oromucosal solution - midazolam

האיחוד האירופי - אנגלית - 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

האיחוד האירופי - אנגלית - 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.,

האיחוד האירופי - אנגלית - 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.