Malta - English - Medicines Authority

viatris healthcare limited damastown industrial park, mulhuddart, dublin 15, dublin , ireland - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - atropine sulfate monohydrate - solution for injection in pre-filled syringe - 0.1 milligram(s)/millilitre - belladonna alkaloids, tertiary amines; atropine - belladonna alkaloids, tertiary amines - atropine sulfate aguettant 0.1 mg/ml, solution for injection in pre-filled syringe is indicated in adults and in paediatric population from birth, but with a body weight superior to 3 kg - as a pre-anaesthetic medication to prevent vagal reactions associated with tracheal intubation and surgical manipulation, - to limit the muscarinic effects of neostigmine, when given postsurgically to counteract non-depolarising muscle relaxants - treatment of hemodynamically compromising bradycardia and/ or atrioventricular block due to excessive vagal tone in emergency situation - cardiopulmonary resuscitation: to treat symptomatic bradycardia and av block - as antidote following overdosage or poisoning with acetylcholinesterase-inhibitors e.g. anticholinesterases, organophosphorus, carbamates and muscarinic mushrooms

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238; a/darwin/9/2021 (h3n2)-like strain (a/darwin/6/2021, ivr-227); b/austria/1359417/2021 - like strain (b/austria/1359417/2021, bvr-26) [victoria lineage]; b/phuket/3073/2013 -like strain (b/phuket/3073/2013, wild type) - suspension for injection in pre-filled syringe - 15 international unit(s) - influenza vaccines; influenza, inactivated, split virus or surface antigen

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: water for injections; sodium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; potassium chloride - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use in adults and children 6 months of age and older. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: water for injections; sodium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; potassium chloride - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use in adults and children 6 months of age and older. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Ireland - English - HPRA (Health Products Regulatory Authority)

bioprojet pharma - epinephrine - solution for injection in pre-filled syringe - 0.15 milligram(s) - adrenergic and dopaminergic agents; epinephrine

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - influenza vaccine, split virion, inactivated - suspension for injection in pre-filled syringe - influenza vaccine (split virion, inactivated) 15 µg - vaccines

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - a, brisbane, h, ivr, kansas, nymc x, phuket, wild type, nymc bx - suspension for injection in pre-filled syringe - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227 15 µg b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) 15 µg b/austria/1359417/2021 - like strain (b/austria/1359417/2021 bvr-26 15 µg a/victoria/4897/2022 (h1n1) pdm09 - like strain (a/victoria/4897/2022 ivr-238 15 µg - vaccines

Malta - English - Medicines Authority

bayer public limited company 400 south oak way, reading berkshire rg2 6ad, united kingdom - gadobutrol - solution for injection in a pre-filled syringe - gadobutrol 1 mmol/ml - contrast media

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

samsung bioepis au pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate heptahydrate; sodium chloride; sucrose; water for injections - adults (18 years and older),rheumatoid arthritis,active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). brenzys can be used in combination with methotrexate. severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,psoriatic arthritis,the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. etanercept has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.,plaque psoriasis,adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,ankylosing spondylitis,the signs and symptoms of active ankylosing spondylitis in adults.,non-radiographic axial spondyloarthritis,treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids .,*active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of greater than or equal to 4.