Kesatuan Eropah - Malta - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

covis pharma europe b.v. - formoterol fumarate dihydrate, aclidinium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - brimica genuair huwa indikat bħala l-manutenzjoni bronkodilatur trattament għall-arja ostruzzjoni u l-serħan mis-sintomi fil-pazjenti adulti bil-marda pulmonari ostruttiva kronika (copd).

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Kesatuan Eropah - Malta - 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.

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

elanco gmbh - monepantel - anthelmintics, - nagħaġ - zolvix-soluzzjoni orali hija spettru wiesa-razza ħafna għall-kura u l-kontroll tal-gastro-nematodu infezzjonijiet u mard assoċjat fin-nagħaġ inklużi l-ħrief, hoggets, it-trobbija tal rams u ngħaġ. spectrum of activity includes fourth larvae and adults of: , haemonchus contortus*;, teladorsagia circumcincta*;, teladorsagia trifurcata*;, teladorsagia davtiani*;, trichostrongylus axei*;, trichostrongylus colubriformis;, trichostrongylus vitrinus;, cooperia curticei;, cooperia oncophora;, nematodirus battus;, nematodirus filicollis;, nematodirus spathiger;, chabertia ovina;, oesophagostomum venulosum. , * inkluż inibit larva. il-prodott mediċinali veterinarju huwa effettiv kontra razez ta 'dawn il-parassiti reżistenti għal (pro) benzimidazoles, levamisole, morantel, lactones makroċikliċi u h. stretti ta 'contortus reżistenti għas-salicylanilides.

Kesatuan Eropah - Malta - 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.

Kesatuan Eropah - Malta - 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.

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

vétoquinol sa - torasemide anidruż - għas-sulfonamidi, sempliċi, ta'limitu dijuretiċi - klieb - għat-trattament ta 'sinjali kliniċi, inkluż edema u effużjoni, relatati ma' insuffiċjenza tal-qalb konġestiva fil-klieb.

Kesatuan Eropah - Malta - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - antigens tal-wiċċ tal-virus tal-influwenza (emagglutinin u neuraminidase) ta 'razza a / vjet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus influwenza a.. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.