Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - tolcapone - marda ta 'parkinson - kontra l-marda ta ' parkinson id-drogi, aġenti dopaminerġiċi oħra - tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-o-methyltransferase (comt). minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. peress li tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' tasmar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiċi għal użu sistemiku - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 u 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1): il - każ tal-asperġillożi invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin b jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali; l - fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin b jew f'pazjenti intolleranti għal amphotericin b;- kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;- kokkidajojdomikożi f'pazjenti b'mard li hu refrattarju għal amphotericin b, itraconazole jew fluconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali;- kandidijażi orofarinġali: bħala l-kura preferita f'pazjenti li għandhom mard sever jew li huma immunokompromessi, li r-rispons għal terapija topika hija mistennija li tkun fqir. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nevirapine - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - il-pilloli u l-orali suspensionviramune huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' l-hiv-1-infettati-adulti, l-adoloxxenti u tfal ta ' kwalunkwe età. - maġġoranza tal-esperjenza miksuba b'viramune hija f'kombinazzjoni ma'impedituri ta'nucleoside reverse-transcriptase (nrtis). l-għażla ta 'terapija sussegwenti wara viramune għandha tkun ibbażżata fuq esperjenza klinika u testijiet ta' reżistenza. 50 u 100 mg rilaxx fit-tul tabletsviramune huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' l-hiv-1-infettati fl-adolexxenti u tfal minn tliet snin u l-fuq u li jistgħu jibilgħu l-pilloli. pilloli b'rilaxx prolongat mhumiex adattati għal 14-il jum taċ-ċomb fil-fażi għal pazjenti li jibdew nevirapine. oħra ta ' nevirapine formulazzjonijiet, bħall-rilaxx immedjat pilloli jew sospensjoni orali għandha tintuża. - maġġoranza tal-esperjenza miksuba b'viramune hija f'kombinazzjoni ma'impedituri ta'nucleoside reverse-transcriptase (nrtis). l-għażla ta 'terapija sussegwenti wara viramune għandha tkun ibbażżata fuq esperjenza klinika u testijiet ta' reżistenza. 400 mg rilaxx fit-tul tabletsviramune huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' l-hiv-1-infettati-adulti, l-adoloxxenti u tfal minn tliet snin u l-fuq u li jistgħu jibilgħu l-pilloli. pilloli b'rilaxx prolongat mhumiex adattati għal 14-il jum taċ-ċomb fil-fażi għal pazjenti li jibdew nevirapine. oħra ta ' nevirapine formulazzjonijiet, bħall-rilaxx immedjat pilloli jew sospensjoni orali għandha tintuża. - maġġoranza tal-esperjenza miksuba b'viramune hija f'kombinazzjoni ma'impedituri ta'nucleoside reverse-transcriptase (nrtis). l-għażla ta 'terapija sussegwenti wara viramune għandha tkun ibbażżata fuq esperjenza klinika u testijiet ta' reżistenza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - defiċjenza ta 'antithrombin iii - aġenti antitrombotiċi - atryn huwa indikat għall-profilassi ta 'tromboemboliżmu fil-vini fil-kirurġija ta' pazjenti b'defiċjenza konġenitali ta 'antithrombin. atryn normalment jingħata flimkien ma 'eparina jew eparina b'piż molekulari baxx.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pharmathen s.a. - ibandronic acid - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - drogi għat-trattament ta 'mard tal-għadam - concentrate for solution for infusion prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. trattament ta ' l-iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - xospata huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti li rkadew jew refrattorji lewkimja majelojde akuta (aml) b'flt3 mutazzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - asfotase alfa - hypofosfatija - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - strensiq huwa indikat għat-terapija tibdil fit-tul tal-enżima fil-pazjenti bl-iskoppjar paediatric hypophosphatasia biex jittrattaw il-manifestazzjonijiet tal-għadam tal-marda.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

inceptua ab - ocriplasmin - mard tar-retina - oftalmoloġiċi - jetrea huwa indikat fl-adulti għat-trattament ta 'traction vitreomacular (vmt), inkluż meta assoċjat ma' toqba makulari ta 'dijametru ta' 400 mikron jew anqas.