Irland - engelska - HPRA (Health Products Regulatory Authority)

medir b.v. - midazolam hydrochloride - nasal spray, solution in single-dose container - midazolam

Irland - engelska - HPRA (Health Products Regulatory Authority)

medir b.v. - midazolam hydrochloride - nasal spray, solution in single-dose container - midazolam

Irland - engelska - HPRA (Health Products Regulatory Authority)

medir b.v. - midazolam hydrochloride - nasal spray, solution in single-dose container - midazolam

Europeiska unionen - engelska - 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. , , ,

Europeiska unionen - engelska - 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.

Europeiska unionen - engelska - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - 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), ischemic 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.

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

wsd agribusiness pty ltd - cypermethrin - topical solution/suspension - cypermethrin pyrethroid active 25.0 g/l - parasiticides - sheep - off shears | ovine - sheep body louse | damalinia ovis (prev. genus) | lice - synthetic pyrethroid re | sheep body lice

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - dicyclanil; diflubenzuron - topical solution/suspension - dicyclanil pyrimidine active 50.0 g/l; diflubenzuron uron active 15.0 g/l - parasiticides - lamb unshorn - up to 3 months old | sheep - off shears | sheep - within 7 days of shearing | ovine - fly strike | poll strike | sheep body louse | blowfly strike | body & crutch strike | body strike only | crutch strike | damalinia ovis (prev. genus) | lice - synthetic pyrethroid re | poll strike | sheep body lice

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - cypermethrin - oral solution/suspension - cypermethrin pyrethroid active 25.0 g/l - parasiticides - sheep - off shears | ovine - sheep body louse | damalinia ovis (prev. genus) | lice - synthetic pyrethroid re | sheep body lice

Malta - engelska - Malta Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals