Unia Europejska - polski - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - wieprzowy - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Unia Europejska - polski - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - leki immunosupresyjne - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 i 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Unia Europejska - polski - EMA (European Medicines Agency)

bayer ag - riociguat - nadciśnienie tętnicze, płucne - leki hipotensyjne do nadciśnienia płucnego - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. skuteczność wykazano w populacji tfu tym etiologii samoistna lub dziedziczna lub tfu tfu, związane z chorobami tkanki łącznej . paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Unia Europejska - polski - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron chlorowodorek - vomiting; neoplasms; nausea; cancer - leki przeciwwymiotne i antinauseants, - akynzeo jest wskazany u dorosłych w profilaktyce ostre i opóźnione nudności i wymioty związane z wysoko emetogenic raka chemioterapii cisplatyną. profilaktyka ostre i opóźnione nudności i wymiotów związanych z umiarkowanie emetogenic raka chemioterapii.

Unia Europejska - polski - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - stwardnienie rozsiane - selektywne leki immunosupresyjne - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Unia Europejska - polski - EMA (European Medicines Agency)

biogen netherlands b.v.  - interferon beta-1a - stwardnienie rozsiane - Иммуностимуляторы, - avonex jest wskazany do leczenia:pacjenci z nawracającymi stwardnieniem rozsianym (ms). w badaniach klinicznych, to obecność dwóch lub więcej zaostrzeń (nawrotów) w ciągu ostatnich trzech lat, bez dowodów ciągłego postępującej przepływu między nawrotami; avonex spowalnia progresję niezdolności do pracy i zmniejsza częstotliwość nawrotów choroby;pacjenci z jednym демиелинизирующих zdarzenie podczas aktywnego procesu zapalnego, jeśli jest to na tyle poważnie, aby zapewnić traktowanie z dożylnym podaniem kortykosteroidów, jeśli alternatywne diagnozy były wyłączone, a jeśli są zdeterminowani, aby być wysokie ryzyko rozwoju klinicznie pewnego ms. avonex powinny być zakończone w pacjentach, którzy rozwijają progressive ms.

Unia Europejska - polski - EMA (European Medicines Agency)

ucb pharma sa - brivaracetam - padaczka - przeciwpadaczkowe narzędzia, - lek briviact jest wskazany jako terapia wspomagająca w leczeniu napadów o częściowym początku z wtórnym uogólnieniem lub bez wtórnego uogólnienia u dorosłych i nastolatków w wieku od 16 lat z padaczką.

Unia Europejska - polski - EMA (European Medicines Agency)

merck europe b.v. - cetrorelix (as acetate) - ovulation; ovulation induction - hormony przysadki i podwzgórza i ich analogi - zapobieganie przedwczesnej owulacji u pacjentów poddawanych kontrolowanej stymulacji jajników, następuje oocytów pick-up i rozród wspomagany technik. w badaniach klinicznych, cetrotide jest używany ludzki менопаузальный kosmówkowej (hmg), jednak ograniczone doświadczenie stosowania rekombinowanego go (fsh) zaproponowali taką samą wydajność.

Unia Europejska - polski - EMA (European Medicines Agency)

viatris limited - besylan klopidogrelu - peripheral vascular diseases; stroke; myocardial infarction - Środki przeciwzakrzepowe - 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). elewacja segmentu st ostry zawał mięśnia sercowego, w połączeniu z asa w leczenie pacjentów kwalifikujących się do leczenia trombolitycznego. 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. aby uzyskać więcej informacji, proszę odnieść się do rozdziału 5.

Unia Europejska - polski - EMA (European Medicines Agency)

taw pharma (ireland) limited - chlorowodorek klopidogrelu - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - Środki przeciwzakrzepowe - , , , , 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. , , ,.