Ástralía - enska - 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.

Malta - enska - Malta Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - enska - Malta Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

Ísrael - enska - Ministry of Health

tzamal bio-pharma ltd - candesartan cilexetil; hydrochlorothiazide - tablets - candesartan cilexetil 16 mg; hydrochlorothiazide 12.5 mg - candesartan and diuretics - candesartan and diuretics - essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.

Írland - enska - HPRA (Health Products Regulatory Authority)

pharma stulln gmbh - ipratropium bromide; salbutamol sulfate - nebuliser solution - 0.5 mg/2.5 milligram(s) - adrenergics in combination with anticholinergics; salbutamol and ipratropium bromide

Írland - enska - 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.

Evrópusambandið - enska - 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.

Evrópusambandið - enska - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotic agents - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult 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., - adult 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., , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke., , for further information please refer to section 5.1. , , ,

Evrópusambandið - enska - EMA (European Medicines Agency)

teva pharma b.v.  - clopidogrel (as hydrobromide) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antithrombotic agents - prevention of atherothrombotic eventsclopidogrel is indicated in:adult 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;adult 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.prevention of atherothrombotic and thromboembolic events in atrial fibrillationin adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.

Evrópusambandið - enska - EMA (European Medicines Agency)

teva b.v. - telmisartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension in adults.