Lemtrada Uniunea Europeană - letonă - EMA (European Medicines Agency)

lemtrada

sanofi belgium - alemtuzumab - multiplā skleroze - selective immunosuppressants - lemtrada indicēts pieaugušiem pacientiem ar recidivējoši-remitējošu multiplo sklerozi (rrms) ar aktīvu slimību, ko nosaka klīniskas vai attēlveidošanas funkcijas.

Noxafil Uniunea Europeană - letonă - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics sistēmiskai lietošanai - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 un 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 un 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. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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 un 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 un 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 un 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. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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 un 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 un 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. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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):- invazīvās aspergillosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b vai itraconazole, vai pacientiem, kuri nepanes no šīm zālēm;- fusariosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, vai pacientiem, kuri nepanes no amfotericīna b;- chromoblastomycosis un mycetoma pacientiem ar slimību, kas ir ugunsizturīgi, lai itraconazole, vai pacientiem, kuri nepanes no itraconazole;- coccidioidomycosis pacientiem ar slimību, kas ir ugunsizturīgi, lai amfotericīna b, itraconazole vai fluconazole, vai pacientiem, kuri nepanes no šīm zālēm;- orofaringālas kandidoze: kā pirmās līnijas terapija pacientiem, kuriem ir smagas slimības vai pat cilvēkiem ar traucētu imūnsistēmu, kuriem atbildes uz aktuāliem terapija ir sagaidāms, ka būs slikti. refractoriness ir definēta kā progresēšanu infekcijas vai nespēja uzlabot pēc vismaz 7 dienas pirms terapijas devas efektīvs pretsēnīšu terapija. 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.

Nucala Uniunea Europeană - letonă - EMA (European Medicines Agency)

nucala

glaxosmithkline trading services - mepolizumabs - astma - zāles obstruktīvu elpceļu slimību, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Orencia Uniunea Europeană - letonă - EMA (European Medicines Agency)

orencia

bristol-myers squibb pharma eeig - abatacepts - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid - imūnsupresanti - reimatoīdais arthritisorencia, kombinācijā ar metotreksātu ir indicēts:ārstēšanā vidēji smagu vai smagu aktīvu reimatoīdo artrītu (ra) pieaugušiem pacientiem, kas atbildēja nepareizi uz iepriekšējo terapiju ar vienu vai vairākām slimību modificējošiem pretreimatisma zāles (dmards), ieskaitot metotreksātu (mtx), vai audzēja nekrozes faktora (tnf)-α inhibitora. attieksme ļoti aktīva un progresējoša slimība pieaugušajiem pacientiem ar reimatoīdo artrītu, kas agrāk nav ārstēti ar metotreksātu. samazināt locītavu bojājumu progresēšanu un uzlabot fizisko funkciju ir pierādīts, ka laikā, kombinējot ārstēšanu ar abatacept un metotreksātu. psoriātisko arthritisorencia, atsevišķi vai kombinācijā ar metotreksātu (mtx), ir indicēts, lai ārstētu aktīvo psoriātisko artrītu (psa) pieaugušiem pacientiem, ja atbilde uz iepriekšējo dmard terapijas, tai skaitā mtx nav bijis pietiekams, un par kuriem papildu sistēmiska terapija psoriātiskā ādas bojājumiem nav nepieciešama. poliartikulāru juvenīlo idiopātisko arthritisorencia kombinācijā ar metotreksātu ir indicēts, lai ārstētu vidēji smagu vai smagu aktīvo poliartikulāru juvenīlo idiopātisko artrītu (pjia) pediatrijas pacientiem 2 gadu vecuma un vecākiem, kam ir bijusi neatbilstoša atbildreakcija uz iepriekšējo dmard terapija. orencia var tikt dota monotherapy gadījumā, ja nepanes metotreksātu vai ja ārstēšana ar metotreksātu ir nevietā.

Xydalba Uniunea Europeană - letonă - EMA (European Medicines Agency)

xydalba

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibakteriālas līdzekļi sistēmiskai lietošanai, - acu bakteriālas ādas un ādas struktūras infekcijas (absssi) ārstēšana pieaugušajiem.

Ranexa (previously Latixa) Uniunea Europeană - letonă - EMA (European Medicines Agency)

ranexa (previously latixa)

menarini international operations luxembourg s.a. (miol) - ranolazine - stenokardija - sirds terapija - ranexa, kas norādīts kā papildinājumu terapija simptomātiskai ārstēšanai pacientiem ar stabila stenokardija, kuri nepietiekami kontrolēts vai nepanes pirmās rindas anti anginal terapiju (piemēram, beta-blokatori un / vai kalcija antagonisti).

ProQuad Uniunea Europeană - letonă - EMA (European Medicines Agency)

proquad

merck sharp & dohme b.v. - virus, live novājināts, masalas, vīrusu, dzīvot novājinātas, cūciņa, vīrusu, dzīvo novājinātas, masaliņas, vīrusu, dzīvot novājināts, varicella - chickenpox; rubella; measles; mumps; immunization - vakcīnas - proquad ir indicēts vienlaicīgai vakcinācijai pret masalām, cūciņām, masaliņām un vējbakām pacientiem no 12 mēnešu vecuma. proquad var ievadīt personām no 9 mēnešu vecuma īpašos apstākļos (e. , lai atbilstu valsts vakcinācijas grafikus, uzliesmojuma situācijas, vai ceļojumu uz reģionu, kur ir augsta saslimstība ar masalām.

Xigduo Uniunea Europeană - letonă - EMA (European Medicines Agency)

xigduo

astrazeneca ab - metformīns hidrohlorīds, dapagliflozin propāndiola monohidrāts - cukura diabēts, 2. tips - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo ir norādīts ārstēšanai pieaugušajiem 2. tipa cukura diabēts, kā palīglīdzekli, lai diētu un vingrinājumiem:• pacientiem, nepietiekami kontrolē to maksimāli pieļaujama devu metformīns vienatnē. • kombinācijā ar citām zālēm, lai ārstētu diabēta pacientiem nepietiekami kontrolēta ar metformīnu un šīs zāles• pacientiem, kas jau tiek ārstēti ar kombināciju dapagliflozin un metformīnu kā atsevišķas tabletes. par pētījuma rezultātiem attiecībā uz ogļūdeņražu terapiju, ietekmi uz glycaemic kontroles un sirds un asinsvadu notikumi, un populācijas izpēte, skatīt 4. 4, 4. 5 un 5.

Tenkasi (previously Orbactiv) Uniunea Europeană - letonă - EMA (European Medicines Agency)

tenkasi (previously orbactiv)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibakteriālas līdzekļi sistēmiskai lietošanai, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 un 5. jāņem vērā oficiālās vadlīnijas par piemērotu izmantot antibakteriālas vielas.

Suboxone Uniunea Europeană - letonă - EMA (European Medicines Agency)

suboxone

indivior europe limited - buprenorfīns, naloksona - ar opioīdiem saistītas slimības - other nervous system drugs - aizstāšanas ārstēšana atkarībā no opioīdiem atkarībā no medicīniskās, sociālās un psiholoģiskās ārstēšanas. naloksona komponentes nolūks ir novērst intravenozu ļaunprātīgu izmantošanu. Ārstēšana paredzēta lietošanai pieaugušajiem un pusaudžiem vecumā virs 15 gadiem, kuri ir vienojušies par atkarības ārstēšanu.