Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrate - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - aġenti antineoplastiċi - tas-sider cancertaxespira flimkien ma 'doxorubicin u cyclophosphamide huwa indikat għall-kura awżiljarja ta' pazjenti bi:operabbli node-kanċer tas-sider posittiv;operabbli node negattivi għall-kanċer tas-sider. għall-pazjenti b'operabbli node negattivi għall-kanċer tas-sider, adjuvant it-trattament għandu jkun ristrett għal pazjenti eliġibbli li jirċievu l-kimoterapija skond internazzjonalment stabbiliti l-kriterji għall-primarja terapija tal-kanċer tas-sider bikri. taxespira flimkien ma 'doxorubicin huwa indikat għat-trattament ta' pazjenti b'avvanzat lokalment jew metastatiku tas-sider tal-kanċer li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. taxespira monoterapija hija indikata għat-trattament ta 'pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment ta' terapija ċitotossika. kemjoterapija preċedenti kellha tinkludi anthracycline jew aġent alkilanti. taxespira flimkien ma 'trastuzumab huwa indikat għat-trattament ta' pazjenti b'kanċer tas-sider metastatiku li t-tumuri tagħhom fuq jesprimu her2, u li preċedentement ma kienux ħadu kimoterapija għall-mard metastatiku. taxespira flimkien ma 'capecitabine huwa indikat għat-trattament ta' pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment tal-kimoterapija ċitotossika. it-terapija ta 'qabel kellha tinkludi anthracycline. taċ-ċelluli mhux żgħar tal-pulmun il-kanċer taxespira indikat għall-kura ta ' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer wara l-falliment tal-kimoterapija qabel. taxespira flimkien ma 'cisplatin huwa indikat għat-trattament ta' pazjenti li ma jistax jitneħħa, avvanzat lokalment jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer, f'pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. kanċer tal-prostata taxespira flimkien ma 'prednisone jew prednisolone huwa indikat għat-trattament ta' pazjenti bl-ormon tat-refrattarji kanċer metastatiku tal-prostata. adenokarċinoma gastrika taxespira flimkien ma 'cisplatin u 5-fluorouracil huwa indikat għat-trattament ta' pazjenti b'adenokarċinoma gastrika metastatika, inkluż l-adenokarċinoma ta ' l-istonku junction, li ma ħadu l-kimoterapija qabel, għal mard metastatiku. - ras u l-għonq tal-kanċer taxespira flimkien ma 'cisplatin u 5-fluorouracil huwa indikat għat-trattament induttiv ta' pazjenti b'lokalment avvanzat tal-karċinoma b'ċelloli squamous tar-ras u l-għonq.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

jenson pharmaceutical services limited - dextromethorphan, quinidine - manifestazzjonijiet ta 'mard newboliku - drogi oħra tas-sistema nervuża - nuedexta huwa indikat għat-trattament sintomatiku ta 'l-effett ta' pseudobulbar (pba) fl-adulti. l-effikaċja ġiet studjata biss f'pazjenti bi sklerożi laterali amjotrofika sottostanti jew sklerosi multipla.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

teva pharma b.v.  - clopidogrel (as hydrobromide) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - aġenti antitrombotiċi - il-prevenzjoni ta 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;f'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);elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. 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 (vka) u li għandhom baxx-riskju ta'fsada, clopidogrel huwa indikat, flimkien ma ' asa għall-prevenzjoni tal-aterotrombotiċi u avvenimenti tromboemboliċi, inkluż puplesija.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - 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), 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). elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. 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. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. wara l-bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex tevalwa l-adegwatezza tal-rispons għall-kura (e. it-tnaqqis fl-hba1c). f'pazjenti li jonqsu li juru rispons adegwat, pioglitazone għandu jitwaqqaf. fid-dawl tar-riskji potenzjali fit-tul mal-terapija, it-tobba għandhom jikkonfermaw fil-sussegwenti ta 'rutina reviżjonijiet li l-benefiċċju ta' pioglitazone jinżamm.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - vyxeos liposomali huwa indikat għall-kura ta ' adulti li jkunu għadhom kif ġew dijanjostikati, it-terapija relatata mal-lewkimja majelojde akuta (t-aml) jew aml mal-majelodisplasija-bidliet relatati mal (aml-mrc).

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

janssen-cilag international n.v.   - palmpalidone palmitate - skizofrenija - psikolettiċi - byannli (previously paliperidone janssen-cilag international) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

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.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - aġenti antitrombotiċi - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.