Ebvallo Европска Унија - Чешки - EMA (European Medicines Agency)

ebvallo

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Европска Унија - Чешки - EMA (European Medicines Agency)

clopidogrel taw pharma (previously clopidogrel mylan)

taw pharma (ireland) limited - hydrochlorid klopidogrelu - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotické činidla - , , , , 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. , , ,.

CYTARABIN KABI 100MG/ML Injekční/infuzní roztok Чешка - Чешки - SUKL (Státní ústav pro kontrolu léčiv)

cytarabin kabi 100mg/ml injekční/infuzní roztok

fresenius kabi s.r.o., praha ČeskÁ republika - 1570 cytarabin - injekční/infuzní roztok - 100mg/ml - cytarabin

Dutrebis Европска Унија - Чешки - EMA (European Medicines Agency)

dutrebis

merck sharp dohme limited - lamivudin, raltegravir draslíku - hiv infekce - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis je indikován v kombinaci s jinými anti‑retroviral léčivými přípravky k léčbě infekce virem lidské imunodeficience (hiv‑1) u dospělých, dospívajících a dětí ve věku od 6 let a vážení alespoň 30 kg bez současnosti nebo minulosti důkazy o virové odolnosti vůči antivirotika ve formě (integrázy strand transfer inhibitor) a nrti (inhibitor reverzní transkriptázy nukleosidové) třídy (viz body 4. 2, 4. 4 a 5.

Tractocile Европска Унија - Чешки - EMA (European Medicines Agency)

tractocile

ferring pharmaceuticals a/s - atosiban (as acetate) - předčasné narození - další gynecologicals - tractotile je uvedeno oddálit hrozící předčasný porod u těhotných dospělých žen s:pravidelné kontrakce dělohy trvající alespoň 30 vteřin, dobu trvání ve výši ≥ 4 za 30 minut;cervikální dilatace 1 až 3 cm (0-3 pro nulliparas) a zahlazení ≥ 50%;gestační věk od 24 do 33 ukončených týdnů;normální fetální srdeční frekvence.

Fingolimod Mylan Европска Унија - Чешки - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod hydrochlorid - roztroušená skleróza, relaps-remitentní - imunosupresiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 a 5. 1)orpatients s rychle se vyvíjející těžkou relabující-remitentní formou roztroušené sklerózy definovanou 2 nebo více relapsy v jednom roce a s 1 nebo více gadolinium enhancing lézí na mri mozku nebo významné zvýšení zátěže t2 lézí ve srovnání s předchozí nedávnou mri.

Fingolimod Mylan Европска Унија - Чешки - EMA (European Medicines Agency)

fingolimod mylan

mylan ireland limited - fingolimod hydrochlorid - roztroušená skleróza, relaps-remitentní - imunosupresiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 a 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

ERMM-1 111MBQ/ML Injekční suspenze Чешка - Чешки - SUKL (Státní ústav pro kontrolu léčiv)

ermm-1 111mbq/ml injekční suspenze

cis bio international, gif-sur-yvette cedex array - 16572 erbium-(169er)-citrÁt - injekční suspenze - 111mbq/ml - erbium-(169er)-citrÁt koloidnÍ

Cymbalta Европска Унија - Чешки - EMA (European Medicines Agency)

cymbalta

eli lilly nederland b.v. - duloxetin - anxiety disorders; diabetic neuropathies; depressive disorder, major - psychoanaleptics, - léčba závažné depresivní poruchy. léčba diabetické periferní neuropatické bolesti. léčba generalizované úzkostné poruchy. přípravek cymbalta je indikován u dospělých.

Duloxetine Lilly Европска Унија - Чешки - EMA (European Medicines Agency)

duloxetine lilly

eli lilly nederland b.v. - duloxetin - neuralgia; diabetic neuropathies; depressive disorder, major - psychoanaleptics, - duloxetine lilly je indikován u dospělých pro:léčbu depresivních disordertreatment diabetické periferní neuropatické paintreatment generalizované úzkostné disorderduloxetine lilly je indikován u dospělých.