Coagadex Europäische Union - Dänisch - EMA (European Medicines Agency)

coagadex

bpl bioproducts laboratory gmbh - human koagulationsfaktor x - faktor x-mangel - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex er indiceret til behandling og profylakse af blødninger episoder og for perioperative management hos patienter med arvelig faktor x mangel. coagadex er angivet i alle aldersgrupper.

Cystadane Europäische Union - Dänisch - EMA (European Medicines Agency)

cystadane

recordati rare diseases - betain vandfri - homocystinuri - andre alimentary tract and metabolism produkter, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Amversio Europäische Union - Dänisch - EMA (European Medicines Agency)

amversio

serb sa - betaine - homocystinuri - andre alimentary tract and metabolism produkter, - amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:•         cystathionine beta-synthase (cbs),•         5,10 methylene tetrahydrofolate reductase (mthfr),•         cobalamin cofactor metabolism (cbl).

Segluromet Europäische Union - Dänisch - EMA (European Medicines Agency)

segluromet

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Adcetris Europäische Union - Dänisch - EMA (European Medicines Agency)

adcetris

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastiske midler - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris er indiceret til behandling af voksne patienter med recidiverende eller refraktær cd30+ hodgkin lymfom (hl):følgende asct, orfollowing mindst to behandlinger, når asct eller multi-agent-kemoterapi er ikke en behandlingsmulighed. systemisk anaplastisk store celle lymphomaadcetris i kombination med cyclophosphamid, doxorubicin og prednison (chp) er indiceret til voksne patienter med tidligere ubehandlet systemisk anaplastisk store celle lymfom (salcl). adcetris er indiceret til behandling af voksne patienter med recidiverende eller refraktær salcl. kutant t-celle lymphomaadcetris er indiceret til behandling af voksne patienter med cd30+ kutant t-celle lymfekræft (ctcl) efter mindst 1 før systemisk terapi.

Alprolix Europäische Union - Dänisch - EMA (European Medicines Agency)

alprolix

swedish orphan biovitrum ab (publ) - eftrenonacog alfa - hæmofili b - k-vitamin og andre hemostatics, blod koagulation faktorer - behandling og profylakse af blødning hos patienter med hæmofili b (medfødt faktor ix-mangel).

Clopidogrel Acino Europäische Union - Dänisch - EMA (European Medicines Agency)

clopidogrel acino

acino ag - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antitrombotiske midler - 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, 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, patients suffering from acute coronary syndrome. , ,.

Clopidogrel Viatris (previously Clopidogrel Taw Pharma) Europäische Union - Dänisch - EMA (European Medicines Agency)

clopidogrel viatris (previously clopidogrel taw pharma)

viatris limited - clopidogrel besilat - peripheral vascular diseases; stroke; myocardial infarction - antitrombotiske midler - 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 akut myokardieinfarkt, i kombination med asa i medicinsk behandlede patienter, der er berettiget til trombolytisk terapi. 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 yderligere oplysninger henvises der til afsnit 5.

Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Europäische Union - Dänisch - EMA (European Medicines Agency)

clopidogrel taw pharma (previously clopidogrel mylan)

taw pharma (ireland) limited - clopidogrelhydrochlorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotiske midler - , , , , 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. , , ,.