Euroopan unioni - malta - EMA (European Medicines Agency)

eli lilly and company limited - spinosad, milbemiċin oxime - prodotti kontra l-parassiti, insettiċidi u sustanzi, endectocides - klieb - għat-trattament u l-prevenzjoni tal-briegħed (ctenocephalides felis) jigdem fil-klieb fejn wieħed jew aktar ta 'l-indikazzjonijiet li ġejjin huma meħtieġa fl-istess ħin: il-prevenzjoni tal-heartworm disease (l3, l4-dirofilaria immitis);il-prevenzjoni tal-angiostrongylosis billi tnaqqas il-livell ta' l-infezzjoni bil-adulti immaturi (l5) ' angiostrogylus vasorum;it-trattament ta'gastro-nematodu infezzjonijiet ikkawżati mill għall (l4, adulti immaturi, l5) u adulti ancylostoma caninum), fl-imsaren (adulti immaturi l5, u l-adulti toxocara canis u adulti toxascaris leonina) u ħniex (adulti trichuris vulpis).

Euroopan unioni - malta - EMA (European Medicines Agency)

laboratoires smb s.a. - fenofibrate, pravastatin - dyslipidemias - aġenti li jimmodifikaw il-lipidi - pravafenix huwa indikat għall-kura ta ' l-għolja-coronary-mard tal-qalb-(chd)-tar-riskju ta ' pazjenti adulti ma dyslipidaemia imħallat karatterizzat mill-trigliċeridi għoli u baxx hdl-cholesterol (c) livelli tagħhom livelli ldl-c huma adegwatament kontrollati filwaqt li fuq- trattament bl-monotherapy pravastatin-40-mg.

Euroopan unioni - malta - EMA (European Medicines Agency)

celgene europe ltd. - lepirudin - thromboembolism; thrombocytopenia - aġenti antitrombotiċi - antikoagulazzjoni f'pazjenti adulti b'tromboċitopenja tat-tip ii indotta mill-eparina u mard tromboemboliku li jimponi terapija antitrombotika parenterali. id-dijanjożi trid tiġi kkonfermata mill-eparina-induced platelet activation assay jew test ekwivalenti.

Euroopan unioni - malta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - antigen tal-wiċċ ta 'l-epatite b - hepatitis b; immunization - vaċċini - fendrix huwa indikat fl-adoloxxenti u adulti mill-età ta ' 15-il sena ' l quddiem għall-immunisation attiva kontra l-infezzjoni tal-mikrobu epatite b (hbv) ikkaġunata sottotipi magħrufa kollha għall-pazjenti b ' insuffiċjenza renali (inkluż pre-haemodialysis u haemodialysis pazjenti).

Euroopan unioni - malta - EMA (European Medicines Agency)

1 a pharma gmbh - rivastigmine - alzheimer disease; dementia; parkinson disease - psychoanaleptics, - trattament sintomatiku ta 'dimenzja ta' alzheimer ħafifa għal moderatament gravi. kura sintomatika ta 'minn ħafifa għal moderatament gravi dimenzja f'pazjenti bil-marda idjopatika ta' parkinson.

Euroopan unioni - malta - EMA (European Medicines Agency)

novartis europharm limited - brinzolamide, brimonidine tartrate - ocular hypertension; glaucoma, open-angle - oftalmoloġiċi - tnaqqis fil-pressjoni intraokulari elevata (iop) f'pazjenti adulti bi glawkoma b'angolu miftuħ jew pressjoni għolja fl-għajnejn li għalihom il-monoterapija tipprovdi tnaqqis iop insuffiċjenti.

Euroopan unioni - malta - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - ceftolozane sulfate, tazobactam sodium - infezzjonijiet batteriċi - antibatteriċi għal użu sistemiku, - zerbaxa is indicated for the treatment of the following infections in adults:complicated intra abdominal infections;acute pyelonephritis;complicated urinary tract infections;hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Euroopan unioni - malta - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - aġenti għad-dermatite, esklużi kortikosterojdi - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Euroopan unioni - malta - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - qtates - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. il-prodott mediċinali veterinarju huwa esklussivament indikat meta l-tliet gruppi huma maħsuba fl-istess ħin.

Euroopan unioni - malta - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - ibandronic acid - hypercalcemia; breast neoplasms; neoplasm metastasis; fractures, bone - drogi għat-trattament ta 'mard tal-għadam - bondronat huwa indikat għal:prevenzjoni ta 'episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer tas-sider u metastasi fl-għadam;trattament ta' l-iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi.