Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

deva holding a s - clarithromycinum + lansoprazolum + kalii - comprimate filmate; capsule; comprimate - 500 mg + 30 mg + 1000 mg

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

hugh source (international) ltd - o toxina botulinică - liofilizat pentru soluţie injectabilă - 100 u

Uniunea Europeană - română - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel clorhidrat - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - agenți antitrombotici - , , , , 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. , , ,.

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - agenți antitrombotici - duoplavin este indicat pentru prevenirea secundară a evenimentelor atherothrombotic la pacienţii adulţi, luaţi deja clopidogrel şi de acid acetilsalicilic (aas). duoplavin is a fixed-dose combination medicinal product for continuation of therapy in: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 (pci);st segment elevation acute myocardial infarction (stemi) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. pentru informații suplimentare vă rugăm să consultați secțiunea 5.

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - agenți antitrombotici - prevenirea secundară a aterotrombotice eventsclopidogrel este indicat în:pacienți adulți cu infarct miocardic (de la câteva zile până la mai puțin de 35 zile), accident vascular cerebral ischemic (mai vechi de 7 zile până la mai puțin de 6 luni) sau boală arterială periferică dovedită. pacienții adulți cu sindrom coronarian acut fără supradenivelare de segment st sindrom coronarian acut (angină pectorală instabilă sau non-q infarct miocardic), inclusiv pacienți supuși implantării de stent după intervenție coronariană percutanată în asociere cu acid acetilsalicilic (aas). st segment elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. prevenirea aterotrombotice și tromboembolice în atrială fibrillationin pacienții adulți cu fibrilație atrială care au cel puțin un factor de risc de evenimente vasculare, nu sunt potrivite pentru tratamentul cu antagoniști ai vitaminei k (vka) și care au un nivel scăzut riscul de sângerare, clopidogrelul este indicat în asociere cu aas pentru prevenirea aterotrombotice și tromboembolice, inclusiv accident vascular cerebral.

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel sulfat acid - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - agenți antitrombotici - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. prevenirea aterotrombotice și tromboembolice în atrială fibrillationin pacienții adulți cu fibrilație atrială care au cel puțin un factor de risc de evenimente vasculare, nu sunt potrivite pentru tratamentul cu vitamina k antagoniști și care au un nivel scăzut riscul de sângerare, clopidogrelul este indicat în asociere cu aas pentru prevenirea aterotrombotice și tromboembolice, inclusiv accident vascular cerebral.

Uniunea Europeană - română - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - imunosupresoare - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Uniunea Europeană - română - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - imunosupresoare - rheumatoid arthritisyuflyma in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab a fost demonstrat de a reduce rata progresiei distrucției articulare prin x-ray și de a îmbunătăți funcția fizică, atunci când este administrat în asociere cu metotrexat. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab nu a fost studiat la pacienții cu vârsta mai mică de 2 ani. enthesitis-related arthritisyuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asyuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psoriatic arthritisyuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab a fost demonstrat de a reduce rata de progresie a distrugerii articulare periferice măsurată prin x-ray la pacienții cu artrită simetrică subtipuri ale bolii (a se vedea secțiunea 5. 1) și de a îmbunătăți funcția fizică. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 și 5. crohn’s diseaseyuflyma is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaseyuflyma is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitisyuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisyuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisyuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitisyuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Uniunea Europeană - română - EMA (European Medicines Agency)

mylan ireland limited - acetat de abirateron - prostate neoplasme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

sc look ahead srl -