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

swedish orphan biovitrum pty ltd - pegcetacoplan, quantity: 1080 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol - empaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who have an inadequate response to, or are intolerant of, a c5 inhibitor.

Israele - inglese - Ministry of Health

pharma shalom - ciclopirox - lacque - ciclopirox 80 mg/g - ciclopirox - ciclopirox - for the treatment of fungal infections of the nails.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - esomeprazole - tablets gastro-resistant - 20 milligram - proton pump inhibitors

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - esomeprazole - tablets gastro-resistant - 40 milligram - proton pump inhibitors

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - omeprazole - gastro-resistant capsule - 10 milligram(s) - proton pump inhibitors; omeprazole

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - omeprazole - gastro-resistant capsule - 20 milligram(s) - proton pump inhibitors; omeprazole

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - omeprazole - gastro-resistant capsule, hard - 40 milligram(s) - proton pump inhibitors; omeprazole

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

mcm pharma gmbh - zoledronic acid monohydrate - concentrate for soln for inf - 4 mg/5ml

Unione Europea - inglese - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - colony stimulating factors - biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.biograstim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.biograstim is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Unione Europea - inglese - EMA (European Medicines Agency)

tad pharma gmbh - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - 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.