Union européenne - estonien - 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.

Union européenne - estonien - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarkoom - antineoplastilised ained - lartruvo on näidustatud täiskasvanud patsientidel kaugelearenenud pehmete kudede sarkoom, kes ei ole sobivad, tervendavat operatsiooni või kiiritusravi ravi ja kes ei ole varem töödeldud ravi doksorubitsiiniga doksorubitsiiniga (vt lõik 5.

Union européenne - estonien - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - granisetroon - vomiting; cancer - antiemeetikumid ja antinauseants, , serotoniini (5ht3) antagonistid - iivelduse ja oksendamise ennetamine patsientidel, kes saavad mõõdukat või väga emetogeenset kemoteraapiat, koos tsisplatiiniga või ilma, kuni viis järjestikust päeva. sancuso võib kasutada saavatel patsientidel oma esimest kemoteraapia raviskeemi või patsientidel, kes on eelnevalt saanud keemiaravi.

Union européenne - estonien - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - idiopaatiline, trombotsütopeeniline purpur - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Union européenne - estonien - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Union européenne - estonien - EMA (European Medicines Agency)

janssen-cilag international nv - ustekinumab - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - immunosupressandid - crohni diseasestelara on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse crohni tõbi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tnfa antagonist või on meditsiinilised vastunäidustused, et selline ravi. haavandiline colitisstelara on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse haavandilise koliidi, kes on olnud ebapiisav vastust, kaotatud vastus, või olid sallimatu kas tavalise ravi või bioloogiline või on meditsiinilised vastunäidustused, et selline ravi. tahvel psoriasisstelara on näidustatud ravi mõõduka kuni raske psoriaas täiskasvanutel, kes ei suutnud reageerida, või kellel on vastunäidustus või ei talu teiste süsteemsete raviviiside, sh ciclosporin, metotreksaadi ja psoralen ultraviolett a. lastel tahvel psoriasisstelara on näidustatud ravi mõõduka kuni raske psoriaas, laste-ja noorukieas patsientidel vanuses 6 aastat ja vanemad, kes on ebapiisavalt kontrollitud, või ei talu, teiste süsteemsete raviviiside või phototherapies. psoriaatilise arthritisstelara, üksi või koos metotreksaadi, on näidustatud ravi aktiivne psoriaatiline artriit täiskasvanud patsientidel, kui vastus eelmisele mitte-bioloogiline haigust moduleeriva reumavastased narkootikumide (dmard) ravi on olnud ebapiisav.

Union européenne - estonien - EMA (European Medicines Agency)

novartis europharm limited - omalizumab - asthma; urticaria - ravimid hingamisteede obstruktiivsete haiguste, - allergiline asthmaxolair on näidustatud täiskasvanud, noorukid ja lapsed (6 kuni.

Union européenne - estonien - EMA (European Medicines Agency)

pfizer europe ma eeig - daptomütsiin - soft tissue infections; skin diseases, bacterial - antibacterials süsteemseks kasutamiseks, - daptomycin on näidustatud ravi järgmiste infektsioonide. täiskasvanute ja laste (1-kuni 17-aastased) patsiendid, kellel on keerulised naha ja pehmete kudede infektsioonid (cssti). täiskasvanud patsientidel, kellel on õigus külgedega nakkuslik endokardiit (rie) tänu staphylococcus aureus. see isrecommended, et otsus kasutada daptomycin tuleks arvesse võtta antibakteriaalsete vastuvõtlikkus organismi ja peaks olema aluseks asjatundja nõu. täiskasvanute ja laste (1-kuni 17-aastased) patsiendid, kellel on staphylococcus aureus ' e bacteraemia (sab). täiskasvanutel kasutamiseks bacteraemia peaks olema seotud rie või cssti, kuigi pediaatrilised patsiendid kasutada bacteraemia peaks olema seotud cssti. daptomycin on aktiivne vastu gram-positiivsed bakterid ainult. kombineeritud infektsioonid, kus gram negatiivsed ja/või teatavate anaeroobsete bakterite kahtlustatakse, daptomycin peaks olema, co-manustada koos asjakohaste antibakteriaalne agent(s). tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

Union européenne - estonien - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - idarukisumab - hemorraagia - kõik muud ravitoimingud - praxbind on konkreetse pöördumise agent dabigatran ja on näidustatud täiskasvanud patsientidel, keda on ravitud pradaxa (dabigatran etexilate) kui kiire pöördumise oma antikoagulantide toimet, on vajalik:erakorralise kirurgia/kiireloomuliste kord;eluohtlikud või kontrollimatu verejooks,.

Union européenne - estonien - EMA (European Medicines Agency)

serono europe limited - efalizumab - psoriaas - immunosupressandid - mõõduka kuni raske kroonilise naastulise psoriaasiga täiskasvanud patsientidele, kes ei reageerinud, või esineb vastunäidustusi või esineb muu süsteemse raviga, sh tsüklosporiini, metotreksaati või puva-ravi (vt lõik 5. 1 - kliiniline efektiivsus).