Euroopa Liit - eesti - EMA (European Medicines Agency)

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - suguhormoonid ja genitaalsüsteemi, - oral contraceptive.

Euroopa Liit - eesti - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-nakkused - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta on näidustatud koos teiste retroviirusevastaste ravimitega inimese immuunpuudulikkuse viiruse 1 (hiv 1) nakkuse raviks 18-aastastel ja vanematel täiskasvanutel. genotypic katsetamine peaks juhendi kasutamine rezolsta.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bayer animal health gmbh - imidaklopriid, moxidectin - antibakteriaalsed tooted, insektitsiidid ja repellendid - dogs; cats; ferrets - dogsfor koertele, kes kannatavad või ohustab, segatud parasiitnakkused:ravi ja ennetamine kirbu nakatumise (ctenocephalides felis),ravi hammustamine täid (trichodectes canis),ravi kõrva lesta nakatumise (otodectes cynotis), sarcoptic mange (põhjustatud sarcoptes scabiei var. canis), demodicosis (põhjustatud demodex canis),ennetamine heartworm haigus (l3 ja l4 vastsed dirofilaria immitis),ravi ringleva microfilariae (dirofilaria immitis),ravi naha dirofilariosis (täiskasvanud etappidel dirofilaria repens)vältimise naha dirofilariosis (l3 vastsed dirofilaria repens),vähendada ringleva microfilariae (dirofilaria repens),ennetamine angiostrongylosis (l4 vastsed ja ebaküps täiskasvanud angiostrongylus vasorum),ravi angiostrongylus vasorum ja crenosoma vulpis,ennetamine spirocercosis (spirocerca lupi),ravi eucoleus (syn. capillaria) boehmi (täiskasvanud),ravi silma uss thelazia callipaeda (täiskasvanud),ravi infektsioonid seedetrakti ümarusse (l4 vastsed, ebaküps täiskasvanud ja täiskasvanute toxocara canis, ancylostoma caninum ja uncinaria stenocephala, täiskasvanute toxascaris leonina ja trichuris vulpis). preparaati võib kasutada osana ravi strateegia kirbu allergia dermatiidi (fad). catsfor kassid kannatavad, või oht, segatud parasiitnakkused:ravi ja ennetamine kirbu nakatumise (ctenocephalides felis),ravi kõrva lesta nakatumise (otodectes cynotis),ravi notoedric mange (notoedres cati),ravi lungworm eucoleus aerophilus (syn. capillaria aerophila) (täiskasvanutel),ennetamine lungworm haigus (l3/l4 vastsed aelurostrongylus abstrusus),ravi lungworm aelurostrongylus abstrusus (täiskasvanud),ravi silma uss thelazia callipaeda (täiskasvanud),ennetamine heartworm haigus (l3 ja l4 vastsed dirofilaria immitis),ravi infektsioonid seedetrakti ümarusse (l4 vastsed, ebaküps täiskasvanud ja täiskasvanute toxocara cati ja ancylostoma tubaeforme). preparaati võib kasutada osana ravi strateegia kirbu allergia dermatiidi (fad). ferretsfor tuhkrud, kes kannatavad või ohustab, segatud parasiitnakkused:ravi ja ennetamine kirbu nakatumise (ctenocephalides felis),ennetamine heartworm haigus (l3 ja l4 vastsed dirofilaria immitis).

Euroopa Liit - eesti - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - koerad - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonasool - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimükoosid süsteemseks kasutamiseks - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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 ja 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 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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 ja 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 ja 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 defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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):- invasiivsed aspergillosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b või itraconazole, või patsientidel, kes ei talu neid ravimeid;- fusariosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, või patsientidel, kes ei talu, amphotericin b;- chromoblastomycosis ja mycetoma patsientidel, kellel on haigus, mis on tulekindlad, et itraconazole, või patsientidel, kes ei talu, itraconazole;- coccidioidomycosis patsientidel, kellel on haigus, mis on tulekindlad, et amphotericin b, itraconazole või fluconazole, või patsientidel, kes ei talu neid ravimeid;- farüngeaalne kandidoos: kui esimese rea ravi patsientidel, kellel on raske haigus, või on immunocompromised, kelle vastus aktuaalne ravi on oodata halb. refractoriness defineeritakse kui infektsiooni progresseerumise või suutmatus parandada pärast vähemalt 7 päeva enne ravi annuste efektiivne seenhaiguste ravi. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda pharma a/s - fentanüül citrate - pain; cancer - valuvaigistid - instanyl on näidustatud läbimurdevalu raviks täiskasvanutel, kes juba saavad säilitusravi opioididega kroonilise vähivalu. läbimurrevalu on vahelduv valu ägenemine, mis esineb muidu kontrollitud püsiva valu taustal.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Euroopa Liit - eesti - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Euroopa Liit - eesti - EMA (European Medicines Agency)

valneva sweden ab - rekombinantse koolera toksiini b allüksuste, vibrio cholerae 01 - cholera; immunization - vaktsiinid - dukoral on näidustatud aktiivseks immuniseerimiseks vibrio cholerae serogrupi o1 poolt põhjustatud haiguste tõttu täiskasvanutel ja 2-aastastel lastel, kes külastavad endeemilisi / epideemilisi alasid. kasutada dukoral tuleks kindlaks määrata, lähtudes ametlikest soovitustest, võttes arvesse epidemioloogia varieeruvust ning ohtu nakatuda haiguse erinevate geograafiliste piirkondade ja reisimise tingimused. dukoral ei tohiks asendada standard kaitsemeetmeid. juhul, kõhulahtisus meetmed rehüdratatsioonist peaks olema algatatud.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformiin vesinikkloriid - suhkurtõbi, tüüp 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.