Малта - английски - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 25 mg - antiinflammatory and antirheumatic products

Малта - английски - Malta Medicines Authority

midas pharma gmbh rheinstrasse 49, 55218 ingelheim, germany - ketoprofen - granules for oral solution - ketoprofen 50 mg - antiinflammatory and antirheumatic products

Малта - английски - Malta Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - apixaban - film-coated tablet - apixaban 2.5 mg - antithrombotic agents

Малта - английски - Malta Medicines Authority

denk pharma gmbh & co. kg prinzregentenstrasse 79 81675 münchen , germany - apixaban - film-coated tablet - apixaban 5 mg - antithrombotic agents

Малта - английски - Malta Medicines Authority

venus pharma gmbh am bahnhof 1-3, werne, d 59368, germany - concentrate for solution for infusion - docetaxel 20 mg/ml - antineoplastic agents

Малта - английски - Malta Medicines Authority

venus pharma gmbh am bahnhof 1-3, werne, d 59368, germany - concentrate for solution for infusion - docetaxel 20 mg/ml - antineoplastic agents

Малта - английски - Malta Medicines Authority

venus pharma gmbh am bahnhof 1-3, werne, d 59368, germany - concentrate for solution for infusion - docetaxel 20 mg/ml - antineoplastic agents

Ирландия - английски - HPRA (Health Products Regulatory Authority)

pharmexon consulting s.r.o - melphalan hydrocholoride - powder and solvent for solution for injection/infusion - 50 milligram(s) - nitrogen mustard analogues; melphalan

Европейски съюз - английски - 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.

Европейски съюз - английски - 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. , , ,