Australien - engelsk - Department of Health (Therapeutic Goods Administration)

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 60 mg - tablet, uncoated - excipient ingredients: calcium hydrogen phosphate dihydrate; magnesium stearate; microcrystalline cellulose - fast temporary relief from a runny nose and reduce the swollen membranes of the nose and sinuses and helping breathe freely.

USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 300 mg - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5-tropic human immunodeficiency virus type 1 (hiv-1) infection in patients 2 years of age and older weighing at least 10 kg. limitations of use: selzentry is contraindicated in patients with severe renal impairment or esrd (crcl less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with maraviroc. durin

USA - engelsk - NLM (National Library of Medicine)

viiv healthcare company - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 25 mg - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5‑tropic human immunodeficiency virus type 1 (hiv‑1) infection in adult and pediatric patients weighing at least 2 kg. limitations of use selzentry is contraindicated in patients with severe renal impairment or esrd (creatinine clearance [crcl] less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 30 mg; chlorphenamine maleate, quantity: 2 mg; paracetamol, quantity: 500.4 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; pregelatinised maize starch; povidone; purified water; erythrosine aluminium lake; stearic acid - temporary relief of the symptoms of sinus headache, pain and nasal congestion (including fever) and hay fever.

Israel - engelsk - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), 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 drl two weeks after initial assessment.

Israel - engelsk - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), 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 drl two weeks after initial assessment.

Saudi-Arabien - engelsk - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca ab, sweden - selumetinib - capsule, hard - 25 mg,

Saudi-Arabien - engelsk - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca ab, sweden - selumetinib - capsule, hard - 10 mg,

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.for further information please refer to section 5.1.