European Union - Latvian - EMA (European Medicines Agency)

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.

European Union - Latvian - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narkolepsija - other nervous system drugs - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

European Union - Latvian - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinuksa nātrijs - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antitrombotiskie līdzekļi - 5 mg / 0. 3 ml un 2 ml. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. novērstu vte pieaugušajiem veikta vēdera operācija, kas tiek uzskatītas par augsta riska trombembolisku komplikāciju, piemēram, pacientiem, kam veic vēdera dobuma vēža operācijas. novērstu vte pieaugušo medicīnas pacientiem, kuri tiek uzskatīti par augsta riska vte un kuras ir izņemtas no apgrozības sakarā ar akūtu slimību, piemēram, sirds mazspēju un / vai akūtas elpošanas traucējumi un / vai akūtas infekcijas vai iekaisuma slimībām. Ārstēšana pieaugušajiem ar akūtu simptomātiska spontāni virspusēji-vēnu tromboze, apakšējo ekstremitāšu bez vienlaicīgas dziļa vēnu tromboze. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. infarkts (stemi) pieaugušiem pacientiem, kas tiek pārvaldīti ar thrombolytics vai kas sākotnēji ir saņemt ne cita veida reperfusion terapija. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml un 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

European Union - Latvian - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirīns - hiv infekcijas - pretvīrusu līdzekļi sistēmiskai lietošanai - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.

Latvia - Latvian - Pārtikas un veterinārais dienests, Zemkopības ministrija

norbrook laboratories (ireland) limited, Īrija - fluniksīns - šķīdums injekcijām - 50 mg/ml - cūkas; liellopi; zirgi

Latvia - Latvian - Pārtikas un veterinārais dienests, Zemkopības ministrija

vetoquinol s.a., francija - tolfenamīnskābe - šķīdums injekcijām - 40 mg/ml - kaķi; suņi

European Union - Latvian - EMA (European Medicines Agency)

plethora pharma solutions limited - lidokaīns, prilocaine - priekšlaicīga ejakulācija - anestēzijas līdzekļi - senstend ir indicēts, lai ārstētu primārajā priekšlaicīgu ejakulāciju pieauguši vīrieši.

European Union - Latvian - EMA (European Medicines Agency)

holostem s.r.l - ex vivo paplašinātas autologas cilvēka radzenes epitēlija šūnas, kas satur cilmes šūnas - stem cell transplantation; corneal diseases - oftalmoloģiskie līdzekļi - Ārstēšana pieaugušiem pacientiem ar vidēji smagu limbal cilmes šūnu trūkums (radzenes virspusēji neovascularisation, ar vismaz diviem radzenes kvadrantos centrālā radzenes iesaistot klātbūtni nosaka un stipri samazinājusies redzes asums), vienpusējas vai divpusējas, jo fiziska vai ķīmiska acs apdegumi. biopsijai ir nepieciešams vismaz 1-2 mm2 nekaitēta limbus.

European Union - Latvian - EMA (European Medicines Agency)

pharmathen s.a. - ibandronic acid - hypercalcemia; fractures, bone; neoplasm metastasis; breast neoplasms - zāles kaulu slimību ārstēšanai - 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. Ārstēšanai audzēju izraisītu hypercalcaemia ar vai bez metastāzēm. film-coated tablets prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

European Union - Latvian - EMA (European Medicines Agency)

eli lilly nederland b.v. - olanzapine - schizophrenia; bipolar disorder - psihoterapija - pārklājumu tabletsadultsolanzapine ir indicēts šizofrēnijas ārstēšanai. olanzapīna ir efektīvi, saglabājot klīnisko uzlabošanos laikā turpināt terapiju pacientiem, kuriem konstatētas sākotnējā apstrāde atbildes. olanzapīna ir indicēts, lai ārstētu vidēji smagu vai smagu mānijas epizode. pacientiem, kuru mānijas epizode ir atbildējusi uz olanzapīna ārstēšana, olanzapīna ir norādīts, lai novērstu atkārtošanos pacientiem ar bipolāriem traucējumiem. injectionadultszyprexa pulveris šķīduma injekcijām ir norādīts ātri kontroles aģitācijas un uzvedības traucējumi pacientiem ar å ¡izofrä " nijas vai mānijas epizode, kad mutiski terapija nav piemērota. Ārstēšana ar zyprexa pulveris šķīduma injekcijām būtu jāpārtrauc un iekšķīgi olanzapīna jāuzsāk, tiklīdz klīniski gadījumā.