Holoclar Unjoni Ewropea - Malti - EMA (European Medicines Agency)

holoclar

holostem s.r.l - ex vivo espanda ċelloli umani awtoloġiċi kornea epithelial li jkun fih iċ-ċelloli staminali - stem cell transplantation; corneal diseases - oftalmoloġiċi - trattament tal-pazjenti adulti ma moderat għal defiċjenza ta ' ċelluli staminali limbal severa (definiti bil-preżenza ta ' l-neovascularisation superfiċjali tal-kornea fi mill-anqas żewġ kwadranti tal-kornea, bl-involviment ċentrali tal-kornea, u severament imfixkla akutezza), unilaterali jew bilaterali, minħabba l-ħruq okulari fiżiċi jew kimiċi. minimu ta '1-2 mm2 ta' limbus imbattal huwa meħtieġ għall-bijopsija.

ChondroCelect Unjoni Ewropea - Malti - EMA (European Medicines Agency)

chondrocelect

tigenix n.v. - Ċelloli tal-qarquċa awtoloġiċi vijabbli kkaratterizzati estiżi ex vivo li jesprimu proteini indikaturi speċifiċi - mard tal-qarquċa - mediċini oħra għal disturbi fis-sistema muskoloskeletali - tiswija ta 'difetti sintomiċi tal-qarquċa singulari tal-kundil femorali ta' l-irkoppa (seklu internazzjonali tat-tiswija tal-qarquċaġjar [icrs] grad iii jew iv) f'adulti. fl-istess ħin asintomatiċi ' feriti fil-qarquċa (icrs grad i jew ii) jistgħu jkunu preżenti. - turija ta'l-effikaċja hija ibbażata fuq prova randomised u kkontrollata l-evalwazzjoni tal-effikaċja tal-chondrocelect f'pazjenti b'leżjonijiet bejn 1 u 5 cm2.

Clopidogrel 1A Pharma Unjoni Ewropea - Malti - EMA (European Medicines Agency)

clopidogrel 1a pharma

acino pharma gmbh  - clopidogrel - mard vaskulari periferali - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti 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 li jbatu mis-sindromu koronarju akut: mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux tal-mewġa q 'infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma' acetylsalicylic acid (asa). l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Fasturtec Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fasturtec

sanofi winthrop industrie - rasburicase - iperurċemija - il-prodotti terapewtiċi l-oħra kollha - it-trattament u l-profilassi ta ' hyperuricaemia akuta, sabiex jiġi evitat falliment renali akuta, fl-adulti, tfal u adolexxenti (età 0 sa 17 snin) ma malignancy ħematoloġiċi mal-piż tumur għolja u f'riskju tumur rapida lysis jew jinxtorob fil bidu ta ' l-chemotherapy.

Infanrix Penta Unjoni Ewropea - Malti - EMA (European Medicines Agency)

infanrix penta

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaċċini - infanrix penta huwa indikat għall-vaċċinazzjoni primarja u booster tat-trabi kontra diphtheria, tetanus, pertussis, epatite b u poliomyelitis.

Kymriah Unjoni Ewropea - Malti - EMA (European Medicines Agency)

kymriah

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - aġenti antineoplastiċi oħra - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Libmeldy Unjoni Ewropea - Malti - EMA (European Medicines Agency)

libmeldy

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - drogi oħra tas-sistema nervuża - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Bondenza (previously Ibandronic Acid Roche) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bondenza (previously ibandronic acid roche)

roche registration ltd. - ibandronic acid - l-osteoporożi, il-menopawża - drogi għat-trattament ta 'mard tal-għadam - trattament ta 'l-osteoporożi f'nisa wara l-menopawża b'riskju akbar ta' ksur. tnaqqis fir-riskju ta ' ksur vertebrali ġie muri. l-effikaċja fuq tal-femora-għonq ksur għadha ma ġietx stabbilita.

Clopidogrel Acino Unjoni Ewropea - Malti - EMA (European Medicines Agency)

clopidogrel acino

acino ag - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - aġenti antitrombotiċi - 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 Acino Pharma Unjoni Ewropea - Malti - EMA (European Medicines Agency)

clopidogrel acino pharma

acino pharma gmbh - clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti 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. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.