Unjoni Ewropea - Rumen - 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 - agenți antineoplazici - 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. pacienții cu egfr sau alk pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi 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.

Unjoni Ewropea - Rumen - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - sindroamele de malabsorbție - alte medicamente pentru tractul digestiv și metabolism, - revestive este indicat pentru tratamentul pacienților în vârstă de 1 an și mai mult cu sindromul bowelului scurt (sbs). pacienții trebuie să fie stabili după o perioadă de adaptare intestinală după o intervenție chirurgicală. revestive este indicat pentru tratamentul pacienților cu vârsta cuprinsă între 1 an și mai sus, cu sindrom de intestin scurt. pacienții trebuie să fie stabili după o perioadă de adaptare intestinală după o intervenție chirurgicală.

Unjoni Ewropea - Rumen - EMA (European Medicines Agency)

bayer pharma ag - regorafenib - neoplasme colorectale - antineoplastic agents, protein kinase inhibitors - stivarga este indicat în monoterapie pentru tratamentul pacienților adulți cu:cancer colorectal metastatic (crc), care au fost tratați anterior cu, sau nu sunt considerați candidați pentru, disponibile terapii - acestea includ chimioterapie pe bază de fluoropirimidine, un anti-vegf terapie și un anti-egfr terapie;inoperabil sau metastatic tumori stromale gastro-intestinale (gist), care a progresat sau intoleranță la tratamentul anterior cu imatinib și sunitinib;carcinom hepatocelular (hcc), care au fost anterior tratați cu sorafenib.

Unjoni Ewropea - Rumen - EMA (European Medicines Agency)

pfizer limited - celecoxib - adenomatous polyposis coli - agenți antineoplazici - onsenal este indicat pentru reducerea numărului de polipi intestinali adenomatoasă în polipoză adenomatoasă familială (fap), ca adjuvant pentru chirurgie şi în continuare supraveghere endoscopica (a se vedea secţiunea 4. efectul de onsenal indusă de reducerea de polipi pe riscul de cancer intestinal, nu a fost demonstrat (a se vedea secțiunile 4. 4 și 5.

Unjoni Ewropea - Rumen - EMA (European Medicines Agency)

proveca pharma limited - bromura de glicopironiu - sialoreea - medicamente pentru tulburări funcţionale gastrointestinale - tratamentul simptomatic al sialorrhoea severe (cronice patologice salivare) la copii şi adolescenţi cu vârste cuprinse între 3 ani şi mai în vârstă cu tulburari neurologice cronice.

Rumanija - Rumen - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

terapia sa - romania - furazolidonum - compr. - 100mg - antiinfectioase intestinale alte antiinfectioase intestinale

Rumanija - Rumen - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

berlin-chemie ag - germania - simethiconum - caps. moi - 40mg - med. pt.tulburari intestinale functionale alte medicamente pt.tulb. intestinale functionale

Rumanija - Rumen - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

magistra c & c - romania - drotaverinum - compr. - 40mg - med. pt.tulburari intestinale functionale papaverina si derivati

Rumanija - Rumen - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

laboratoires mayoly spindler - franta - combinatii - caps. moi - 60mg/300mg - med. pt.trat.tulburarilor functionale gastro-intestinale alte medicamente pt.tulb. intestinale functionale

Rumanija - Rumen - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

berlin-chemie ag - germania - simethiconum - pic. orale, emulsie - 40mg/ml - med. pt.tulburari intestinale functionale alte medicamente pt.tulb. intestinale functionale