Uniunea Europeană - română - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - carcinom, pulmonar non-celulă mică - alte medicamente antineoplazice, inhibitori de proteinkinază - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astrazeneca ab - osimertinibum - comprimate filmate - 80 mg

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astrazeneca ab - osimertinibum - comprimate filmate - 40 mg

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

astrazeneca ab - suedia - osimertinib - compr. film. - 40mg - alte antineoplazice inhibitori de protein-kinaza

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

astrazeneca ab - suedia - osimertinib - compr. film. - 80mg - alte antineoplazice inhibitori de protein-kinaza

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - agenți antineoplazici - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanomul - agenți antineoplazici - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 și 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. non-cancer pulmonar cu celule mici (nsclc)trametinib în combinație cu dabrafenib este indicat pentru tratamentul pacienților adulți cu avansate non-cancer pulmonar cu celule mici, cu o mutație braf v600.

Uniunea Europeană - română - EMA (European Medicines Agency)

roche registration gmbh - cobimetinib hemifumarat - melanomul - agenți antineoplazici - cotellic este indicat pentru utilizarea în combinaţie cu vemurafenib pentru tratamentul pacienţilor adulţi cu melanom metastatic sau unresectable cu o mutatia braf v600.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanomul - agenți antineoplazici - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 și 5. tratamentul adjuvant al melanomadabrafenib în combinație cu trametinib este indicat pentru tratamentul adjuvant al pacienților adulți cu etapa a iii-a melanom cu mutație braf v600, în urma rezecției complete. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

glaxo wellcome, s.a. - spania - trametinibum - compr. film. - 0,5mg - inhibitori de protein-kinaza