Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - stocrin huwa indikat fit-trattament ta 'kombinazzjoni antivirali ta' adulti, adolexxenti u tfal ta 'tlett snin u aktar b'infezzjoni ta' hiv-1 tal-bniedem-immunodefiċjenza-virus-1. stocrin ma ġiex studjat biżżejjed fil-pazjenti f'fażi avvanzata tal-marda tal-hiv, u speċifikament pazjenti b'għadd cd4 < 50 ċellula/mm3, jew wara falliment ta ' protease inhibitor (pi) taħt kuri li kien fihom. għalkemm il-reżistenza msallba ta 'efavirenz ma' pis ma ġietx dokumentata, fil-preżent hemm biżżejjed informazzjoni fuq l-effikaċja tal-użu sussegwenti tal-pi tal-kura kombinata bbażata fuq wara li jkunu fallew il-kuri li fihom stocrin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatika neoplażmi, il-kastrazzjoni-reżistenti - aġenti antineoplastiċi - treatment of adult patients with prostate cancer.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - , , , , 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. , , ,.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - prevenzjoni sekondarja tal-aterotrombotiċi eventsclopidogrel huwa indikat f': pazjenti adulti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. pazjenti adulti li jsofru mis-sindromu koronarju akut:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma ' acetylsalicylic acid (asa). 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. il-prevenzjoni ta aterotrombotiċi u avvenimenti tromboemboliċi fil-fibrillazzjoni ta 'l-fibrillationin pazjenti adulti li jbatu minn fibrillazzjoni atrijali li jkollhom mill-inqas fattur ta' riskju wieħed għall-episodji vaskulari, mhumiex adattati għall-kura bl-antagonisti tal-vitamina k (vka) u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma ' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel hydrogen sulfate - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - aġenti antitrombotiċi - 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. il-prevenzjoni ta aterotrombotiċi u avvenimenti tromboemboliċi fil-fibrillazzjoni ta 'l-fibrillationin pazjenti adulti li jbatu minn fibrillazzjoni atrijali li jkollhom mill-inqas fattur ta' riskju wieħed għall-episodji vaskulari, mhumiex adattati għall-kura bil-vitamina k antagonisti u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma ' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - duoplavin huwa indikat għall-prevenzjoni sekondarja ta 'avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qegħdin jieħdu clopidogrel u acetylsalicylic acid (asa). 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. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplażmi fl-ovarji - aġenti antineoplastiċi - ta 'l-ovarji cancerlynparza huwa indikat bħala monoterapija għall -: l-manteniment tat-trattament ta' pazjenti adulti b'avvanzat (medjevali stadji iii u iv) brca1/2 mutat (linja ġerminali u/jew somatiċi) ta 'grad għoli ta' l-epitilju ta 'l-ovarji, tubu fallopjan jew primarja peritoneali-kanċer li huma fir-rispons (sħiħa jew parzjali) wara t-tlestija ta' l-ewwel linja bbażata fuq il-platinu ' kimoterapija. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 u 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. il-pazjenti għandu jkollhom qabel kienu kkurati bil-anthracycline u taxane fil - (neo)adjuvant jew metastatiku-istabbiliment sakemm il-pazjenti li ma kienux tajbin għal dawn it-trattamenti (ara sezzjoni 5. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandu wkoll għamlu progress fuq jew wara qabel l-terapija endokrinali, jew jiġu kkunsidrati bħala mhux adattati għal terapija endokrinali. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - neoplasmi prostatiċi - radjofarmaċewtiċi terapewtiċi - xofigo huwa indikat għat-trattament ta 'adulti b'kanċer tal-prostata li jiflaħ għall-kastrazzjoni, metastasi sintomatika fl-għadam u l-ebda metastasi viscerali magħrufa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - immunosoppressanti - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. l-effikaċja ntweriet f'aph idjopatika (ipah) u f'pah relatata mal-marda vaskulari tal-kollaġen. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.