Европейски съюз - естонски - EMA (European Medicines Agency)

elanco gmbh - tulatromütsiin - antibakteriaalsed ained süsteemseks kasutamiseks - 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. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. 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. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. the product should only be used if pigs are expected to develop the disease within 2–3 days. lambad: nakkusliku pododermatiidi (suu mädanemine) varajase staadiumi ravi, mis on seotud virulentse dichelobacter nodosus'ega ja vajab süsteemset ravi.

Европейски съюз - естонски - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafiil - erektiilne düsfunktsioon - uroloogilised ravimid - erektsioonihäire ravi. tadalafiili tõhususe tagamiseks on vajalik seksuaalne stimulatsioon. cialis ei ole näidustatud kasutamiseks naistel.

Европейски съюз - естонски - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - teadlik sedatsioon - psühhoeptikumid - täiskasvanute intensiivravi osakonna rahustidel patsientidel, kes vajavad sedatiivset taset, mis pole verbaalse stimulatsiooni vastusena sügavam kui erutus (vastab richmondi agitation-sedatsioon skaalale (rass) 0-3).

Европейски съюз - естонски - EMA (European Medicines Agency)

novartis europharm limited - canakinumab - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - interleukiin inhibiitorid, - perioodilise palaviku syndromesilaris on näidustatud ravi järgmiste autoinflammatory perioodilise palaviku sündroom täiskasvanutel, noorukitel ja lastel vanuses 2 aastat ja vanemad:cryopyrin-associated perioodilise syndromesilaris on näidustatud ravi cryopyrin-associated perioodilised sündroomid (caps), sealhulgas:muckle-kaevude sündroom (mws),vastsündinute algusega multisystem põletikuline haigus (nomid) / krooniline infantiilne närvisüsteemi, naha, articular sündroom (cinca),raskete vormide perekondliku külma autoinflammatory sündroomi (fcas) / perekondliku külmast urtikaaria (fcu) esineb märke ja sümptomeid kaugemale külma põhjustatud urticarial nahalööve. tuumori nekroosi faktori retseptori seotud perioodiliste sündroom (mÕrrad)ilaris on näidustatud ravi kasvaja nekroosi faktori (tnf) seotud retseptori perioodilise sündroom (mÕrrad). hyperimmunoglobulin d sündroom (hids)/mevalonate kinase puudus (mkd)ilaris on näidustatud ravi hyperimmunoglobulin d sündroom (hids)/mevalonate kinase puudus (mkd). perekondlik vahemere palavik (fmf)ilaris on näidustatud ravi perekondlik vahemere palavik (fmf). ilaris tuleks koos kolhitsiin, kui see on asjakohane. ilaris on näidustatud ka ravi:ikka on diseaseilaris on näidustatud ravi aktiivse ikka tõbi sh täiskasvanud algusega ikka tõbi (aosd) ja süsteemne juveniilne idiopaatiline artriit (sjia) patsientidel vanuses 2 aastat ja vanemad, kes vastasid valesti, et eelmise ravi mittesteroidsete põletikuvastaste ravimite (mspva) ja süsteemsed kortikosteroidid. ilaris saab antud monotherapy või koos metotreksaadi. gouty arthritisilaris on näidustatud sümptomaatiline ravi täiskasvanud patsientidel, kellel on sagedased podagrahoogude rünnakud (vähemalt 3 rünnakud viimase 12 kuu jooksul), kellest mittesteroidsed põletikuvastased ravimid (mspva) ja kolhitsiini on vastunäidustatud, ei ole talutav, või ei anna adekvaatset vastust, ja kellele korrata kursuste kortikosteroidid ei sobi.

Европейски съюз - естонски - EMA (European Medicines Agency)

zoetis belgium sa - tulatromütsiin - antibakteriaalsed ained süsteemseks kasutamiseks - pigs; cattle; sheep - veised: ravi-ja metaphylaxis veiste hingamisteede haigusi (brd) on seotud mannheimia haemolytica, pasteurella multocida, histophilus somni ja mycoplasma bovis tundlik tulatromütsiin. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. tulatromütsiinile tundlike moraxella bovis'e nakkusliku veiste keratokonjunktiviidi (ibk) ravi. sead: ravi-ja metaphylaxis sigade hingamisteede haigus (erm) seotud actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis ja bordetella bronchiseptica tundlik tulatromütsiin. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. draxiini tuleks kasutada ainult siis, kui sigadel tekib haigus 2-3 päeva jooksul. lambad: nakkusliku pododermatiidi (suu mädanemine) varajase staadiumi ravi, mis on seotud virulentse dichelobacter nodosus'ega ja vajab süsteemset ravi.

Европейски съюз - естонски - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastilised ained - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patsiendid, kellel on egfr-või kristallimise positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Европейски съюз - естонски - EMA (European Medicines Agency)

amgen europe b.v. - denosumab - fractures, bone; neoplasm metastasis - narkootikumid luuhaiguste raviks - ennetamine lihaskonna seotud sündmused (patoloogiline murd, kiirguse ja luu, seljaaju kompressiooni või operatsiooni, et luu) täiskasvanutel kaugelearenenud malignancies seotud luu (vt lõik 5. ravi täiskasvanutel ja skeletally küps noorukid hiiglaslik kasvaja rakkude luu, mis on unresectable või kui kirurgiline resektsioon tõenäoliselt põhjustada haigestumist. .

Европейски съюз - естонски - EMA (European Medicines Agency)

ratiopharm gmbh - sildenafiil - erektiilne düsfunktsioon - uroloogilised ravimid - erektsioonihäire on võimetus saavutada või säilitada peenise erektsioon, mis on piisav rahuldava suguelu meeste raviks. et sildenafiili efektiivne, on vajalik seksuaalne stimulatsioon.

Европейски съюз - естонски - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafiil - erektiilne düsfunktsioon - uroloogilised ravimid - erektsioonihäire ravimine täiskasvanud meestel. tadalafiili tõhususe tagamiseks on vajalik seksuaalne stimulatsioon. tadalafiil lilly ei ole näidustatud kasutamiseks naistel. ravi nähud ja sümptomid eesnäärme healoomulise hüperplaasia täiskasvanud meestel.

Европейски съюз - естонски - EMA (European Medicines Agency)

actavis group ptc ehf   - zoledroonhappe monohüdraat - luumurrud - narkootikumid luuhaiguste raviks - patsientidel luustikuga seotud luukude haarava (patoloogilised luumurrud, seljaaju kompressioon, kiiritusravi või operatsioon luu või kasvajast). ravi täiskasvanud patsientidel, kellel kasvaja põhjustatud hypercalcaemia.