Kesatuan Eropah - Romania - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunosupresoare - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunosupresoare - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 și 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru transplant. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 și 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - abirateronum - compr. - 250mg - antagonisti hormonali si substante inrudite alti antagonisti hormonali si substante inrudite

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - abirateronum - compr. film. - 500mg - antagonisti hormonali si substante inrudite alti antagonisti hormonali si substante inrudite

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

remedica ltd - cipru - abirateronum - compr. film. - 250mg - antagonisti hormonali si substante inrudite alti antagonisti hormonali si substante inrudite

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

remedica ltd - cipru - abirateronum - compr. film. - 500mg - antagonisti hormonali si substante inrudite alti antagonisti hormonali si substante inrudite

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

pfizer europe ma eeig - bortezomib - mielom multiplu - alți agenți antineoplazici - bortezomib hospira ca monoterapie sau în asociere cu doxorubicină lipozomală pegilată sau dexametazona este indicat pentru tratamentul pacienților adulți cu mielom multiplu progresiv care au primit cel puțin 1 tratament anterior și care au suferit deja sau care nu sunt eligibili pentru transplant de celule stem hematopoietice. bortezomib hospira în asociere cu melfalan și prednison este indicat pentru tratamentul pacienților adulți cu mielom multiplu netratați anterior, care nu sunt eligibili pentru chimioterapie în doze mari asociată cu transplant de celule stem hematopoietice. bortezomib hospira în asociere cu dexametazonă sau cu dexametazonă și talidomidă, este indicat pentru tratament de inducție la pacienți adulți cu mielom multiplu netratați anterior, care sunt eligibili pentru chimioterapie în doze mari asociată cu transplant de celule stem hematopoietice. bortezomib hospira în asociere cu rituximab, ciclofosfamidă, doxorubicină și prednison este indicat pentru tratamentul pacienților adulți cu netratați anterior, limfom de manta, care nu sunt eligibili pentru transplant de celule stem hematopoietice.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplasme ovariene - agenți antineoplazici - ovarian cancerlynparza este indicat ca monoterapie pentru:tratament de întreținere pentru pacienții adulți cu avansate (figo stadiile iii și iv) brca1/2-mutant (germline și/sau somatice) de înaltă calitate epitelial ovarian, al trompelor uterine sau cancer peritoneal primar care sunt în răspuns (completă sau parțială) după finalizarea prima linie de chimioterapie pe bază de platină. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 și 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacienții ar trebui să au fost tratați anterior cu o antraciclină și un taxan în (neo)adjuvantă sau metastatic dacă pacienții nu au fost potrivite pentru aceste tratamente (a se vedea secțiunea 5. pacientele cu receptori hormonali (hr)-pozitiv cancer de san ar trebui, de asemenea, au progresat pe sau după o prealabilă terapie endocrine, sau să fie considerate nepotrivite pentru terapia endocrină. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomide - mielom multiplu - imunosupresoare - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

dr. reddy's laboratories (uk) ltd - marea britanie - imatinibum - caps. - 100mg - alte antineoplazice inhibitori de protein-kinaza