New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - promethazine hydrochloride 1 mg/ml ((excludes manufacturing overage of 5%)); promethazine hydrochloride 1 mg/ml ((excludes manufacturing overage of 5%)) - elixir - 5 mg/5ml - active: promethazine hydrochloride 1 mg/ml ((excludes manufacturing overage of 5%)) excipient: citric acid banana flavour 103 sunset yellow purified water sodium benzoate sucrose vanillin active: promethazine hydrochloride 1 mg/ml ((excludes manufacturing overage of 5%)) excipient: citric acid disodium edetate glycerol hyetellose banana flavour 103 propyl gallate propylene glycol purified water quinoline yellow sodium benzoate sodium citrate sunset yellow fcf vanillin - 1. treatment of allergic conditions including some allergic reactions to drugs, urticaria and allergic contact dermatitis, and allergic reactions to insect bites and stings 2. relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis 3. anti-emetic for vomiting from various causes including post-operative vomiting, irradiation sickness, drug induced nausea and motion sickness 4. sedation - for short term use in adults under the advice of a doctor or pharmacist, do not use for more than 7-10 consecutive days 5. promethazine has sedative effects and can be used in the symptomatic management of measles and chickenpox. 6. promethazine can be used as a pre-anaesthetic medication for the prevention and control of post-operative vomiting.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 400 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 600 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - caffeine anhydrous; codeine phosphate; paracetamol - caplets - paracetamol 500 mg; caffeine anhydrous 50 mg; codeine phosphate 15 mg - paracetamol, combinations excl. psycholeptics - paracetamol, combinations excl. psycholeptics - for the relief of pain and coughs and for the reduction of fever accompanied by pain.

Israel - English - Ministry of Health

gsk consumer healthcare, israel ltd - acetylsalicylic acid; caffeine; paracetamol - caplets - paracetamol 250 mg; acetylsalicylic acid 250 mg; caffeine 65 mg - paracetamol, combinations excl. psycholeptics - paracetamol, combinations excl. psycholeptics - for temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual descomfort and pain accompanied by fever.

European Union - English - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b: treatment of adult patients with chronic hepatitis b associated with evidence of hepatitis b viral replication (presence of hbv-dna and hbeag), elevated alanine aminotransferase (alt) and histologically proven active liver inflammation and/or fibrosis.chronic hepatitis c:adult patients:introna is indicated for the treatment of adult patients with chronic hepatitis c who have elevated transaminases without liver decompensation and who are positive for serum hcv-rna or anti-hcv (see section 4.4).the best way to use introna in this indication is in combination with ribavirin.chidren and adolescents:introna is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis c, not previously treated, without liver decompensation, and who are positive for serum hcv-rna. the decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load. the expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Israel - English - Ministry of Health

j-c health care ltd - cobicistate; darunavir as ethanolate - film coated tablets - cobicistate 150 mg; darunavir as ethanolate 800 mg - darunavir - rezolsta is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v).שינוי משטר מינון 2/4/2019pregnancy and postpartumtreatment with rezolsta during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). therefore, therapy with rezolsta should not be initiated during pregnancy, and women who become pregnant during therapy with rezolsta should be switched to an alternative regimen, see section 4.4 and 4.6. darunavir/ritonavir may be considered as an alternative.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

dr. willmar schwabe gmbh & co. kg - valeriana officinalis l., root, dry extract 160 mg; melissa officinalis l., leaf, dry extract 80 mg - coated tablet - melissa officinalis, leaf, dry extract 80 mg; valeriana officinalis, root, dry extract 160 mg - hypnotics and sedatives in combination, excl. barbiturates

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoria qualiphar sa-nv - crataegus monogyna jacq. (lindm.) and-or c. laevigata (poiret) d.c., leaf & flower, dry extract - quantified, ethanol, 75, 4-6_1 25 mg; passiflora incarnata l., herb, dry extract, etoh, 60, 1-2,5_1 25 mg; valeriana officinalis l., root, dry extract - quantified, etoh, 70, 5-6_1 100 mg - capsule, hard - crataegus oxyacantha, flower, dry extract 25 mg; passiflora incarnata herb, dry extract 25 mg; valeriana officinalis, root, dry extract 100 mg - hypnotics and sedatives in combination, excl. barbiturates