Evropská unie - angličtina - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassium - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (hiv‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the insti (integrase strand transfer inhibitor) and nrti (nucleoside reverse transcriptase inhibitor) classes (see sections 4.2, 4.4 and 5.1).

Evropská unie - angličtina - EMA (European Medicines Agency)

sanofi-aventis - rimonabant - obesity - antiobesity preparations, excl. diet products - as an adjunct to diet and exercise for the treatment of obese patients (bmi 30 kg/m2), or overweight patients (bmi 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).

Evropská unie - angličtina - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - lipid modifying agents - nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach ldl-c goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

crescent pharma limited - prednisolone - tablets gastro-resistant - 2.5 milligram - prednisolone - glucocorticoids - it is indicated for: allergy and anaphylaxis; arteritis/collagenosis; blood disorders; cardiovascular disorders; endocrine disorders; gastro-intestinal disorders; hypercalcaemia; infections (with appropriate chemotherapy); muscular disorders; neurological disorders; ocular disease; renal disorders; respiratory disease; rheumatic disorders; skin disorders.

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

crescent pharma limited - prednisolone - tablets gastro-resistant - 5 milligram - prednisolone - glucocorticoids - it is indicated for: allergy and anaphylaxis; arteritis/collagenosis; blood disorders; cardiovascular disorders; endocrine disorders; gastro-intestinal disorders; hypercalcaemia; infections (with appropriate chemotherapy); muscular disorders; neurological disorders; ocular disease; renal disorders; respiratory disease; rheumatic disorders; skin disorders.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - omega-3-acid ethyl esters 90, quantity: 1000 mg - capsule, soft - excipient ingredients: purified water; gelatin; glycerol; d-alpha-tocopherol - hypertriglyceridaemia: endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. treatment is indicated for the following types of dyslipidaemia (fredrickson classification) only: -type iv & v as monotherapy and with close monitoring of ldl-c levels. - type iib as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient. patients with higher baseline levels of triglycerides are more likely to exhibit a better response to omacor. omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). there are insufficient data to support the use in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.

Evropská unie - angličtina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir mylan, co-administered with low dose ritonavir, is indicated for the treatment of hiv 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations). there are very limited data available from children aged 6 to less than 18 years.the choice of atazanavir mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Evropská unie - angličtina - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hydrochloride, naltrexone hydrochloride - obesity; overweight - antiobesity preparations, excl. diet products - mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial body mass index (bmi) of≥ 30 kg/m2 (obese), or≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)treatment with mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Evropská unie - angličtina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of hiv-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations).the choice of reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 pi mutations). the choice of reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).

Evropská unie - angličtina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv infections - antivirals for systemic use - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).