Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - telmisartan - aġenti li jaġixxu fuq is-sistema renin-anġjotensin, antagonisti ta ' angiotensin ii, sempliċi - qtates - tnaqqis ta 'proteinuria assoċjata ma' mard kroniku tal-kliewi (ckd).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer animal health gmbh  - pradofloxacin - antibatteriċi għal użu sistemiku, fluoroquinolones - dogs; cats - dogstreatment ta':infezzjonijiet ta 'ġrieħi kkawżati minn strejns suxxetibbli ta' l-staphylococcus intermedius-grupp (inkluż i. pseudintermedius);superfiċjali u l-fond pijoderma ikkawżata minn strejns suxxetibbli ta ' l-staphylococcus intermedius-grupp (inkluż i. pseudintermedius);akuta urinarja-passaġġ infezzjonijiet ikkawżati minn razez suxxettibbli ta ' eschericia coli u staphylococcus intermedius-grupp (inkluż i. pseudintermedius);bħala trattament aġġuntiv għall-mekkaniċi jew kirurġiċi perjodontali-terapija fit-trattament ta 'infezzjonijiet severi tal-gingiva u perjodontali-tessuti ikkawżata minn strejns suxxetibbli ta' l-organiżmi anaerobiċi, per eżempju porphyromonas spp. u prevotella spp. catstreatment ta 'infezzjonijiet akuti tal-passaġġ respiratorju ta'fuq ikkawżata minn strejns suxxetibbli ta' pasteurella multocida, escherichia coli u staphylococcus intermedius-grupp (inkluż i. pseudintermedius).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

intervet international bv - tildipirosin - antiinfectives għall-użu sistemiku - pigs; cattle - 40 mg/ml soluzzjoni għall-injezzjoni għall-pigstreatment u metaphylaxis tal-marda respiratorja fil-majjali (srd) assoċjata ma ' actinobacillus pleuropneumoniae, pasteurella multocida, bordetella bronchiseptica u haemophilus parasuis sensittivi għal tildipirożin. il-preżenza tal-marda fil-merħla għandha tiġi kkonfermata qabel ma tiġi implimentata l-metaphylaxis. 180 mg/ml soluzzjoni għall-injezzjoni għall-cattlefor-trattament u l-prevenzjoni tal-marda respiratorja fil-bovini (brd) assoċjata ma ' mannheimia haemolytica, pasteurella multocida u histophilus somni sensittivi għall-tildipirożin. il-preżenza tal-marda fil-merħla għandha tiġi kkonfermata qabel it-trattament preventiv.

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)

elanco gmbh - lotilaner - ektoparasitaċidali għall-użu sistemiku, isoxazolines - dogs; cats - għat-trattament tal-briegħed u l-qurdien infestazzjonijiet. il-briegħed u l-qurdien għandhom jingħaqdu ma 'l-ospitant u jibdew jgħumu sabiex ikunu esposti għas-sustanza attiva. il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija tat-trattament għall-kontroll ta' dermatite allerġika tal-bergħud (fad). dogsthis-prodott mediċinali veterinarju jipprovdi immedjata u persistenti joqtol l-attività għal xahar 1 għall-briegħed (ctenocephalides felis u c. canis) u l-qurdien (rhipicephalus sanguineus, ixodes ricinus, i. hexagonus u dermacentor reticulatus). catsthis-prodott mediċinali veterinarju jipprovdi immedjata u persistenti joqtol l-attività għal xahar 1 kontra l-briegħed (ctenocephalides felis u c. canis) u l-qurdien (ixodes ricinus).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

beevital gmbh - l-aċidu ossaliku dihydrate, formiku - ektoparasitaċidali għall-użu topiku, inklużi. insettiċidi - naħal - kura tal-varrożi (varroa destructor) f'kolonji tan-naħal tal-għasel bir-rimja jew le.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

schering-plough europe - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiċi għal użu sistemiku - posaconazole sp huwa indikat għall-użu fit-trattament ta 'l-infezzjonijiet fungali li ġejjin fl-adulti (ara sezzjoni 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. posaconazole sp huwa indikat ukoll għal profilassi ta 'infezzjonijiet fungali invażivi fil-pazjenti li ġejjin:- pazjenti li kienu qed jirċievu remissjoni-induzzjoni ta' kimoterapija għal lewkimja majeloġenuża akuta (aml) jew għal sindromi majelodisplastiċi (mds) mistennija li jikkawżaw newtropenja u li areat riskju għoli li jiżviluppaw infezzjonijiet tal-fungu invażivi;- trapjant ta'ċelloli staminali ematopojetiċi (hsct) riċevituri li huma għaddejjin minn doża għolja ta ' terapija immunosopprimenti għal-graft kontra l-host u li huma f'riskju għoli li jiżviluppaw infezzjonijiet invażivi tal-fungu.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - besponsa huwa indikat bħala monoterapija għall-kura ta ' adulti b'all rikadut jew refrattarju cd22-pożittivi taċ-ċellula b prekursur li għandhom lewkimja limfoblastika akuta (all). pazjenti adulti bi prekursur taċ-ċelluli b tal-kromożomi posittivi (ph +) li rkadew jew refrattarji ta 'philadelphia kollha kellhom ikunu fallew il-kura b'inqas minn 1 tyrosine kinase inhibitor (tki).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

virbac s.a. - tulathromycin - antibacterials għal użu sistemiku - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. il-preżenza tal-marda fil-merħla għandha tiġi stabbilita qabel it-trattament metaphylactic. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. il-preżenza tal-marda fil-merħla għandha tiġi stabbilita qabel it-trattament metaphylactic. the product should only be used if pigs are expected to develop the disease within 2–3 days. nagħaġ: trattament tal-istadji bikrija ta 'pododermatite infettiva (taħsir tas-sieq) assoċjat ma' dichelobacter nodosus virulenti li jeħtieġ trattament sistemiku.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - neoplasmi prostatiċi - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.