Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

European Union - English - EMA (European Medicines Agency)

acino pharma gmbh  - clopidogrel - peripheral vascular diseases - 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.patients suffering from acute coronary syndrome:- non st segment elevation acute coronary syndrome (unstable angina or non q wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).- st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.for further information please refer to section 5.1.

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

hope pharmaceuticals pty ltd - sodium thiosulfate pentahydrate, quantity: 12.5 g - solution - excipient ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide - hope pharmaceuticals sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite.,sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

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

hope pharmaceuticals pty ltd - sodium nitrite, quantity: 300 mg - solution - excipient ingredients: water for injections - sodium nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

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

mayne pharma international pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; maize starch; stearic acid - mayne pharma oxycodone ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 5 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 10 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 20 mg - urologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

pharma nord aps - melatonin - film-coated tablet - 3 milligram(s) - melatonin