Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - multipelt myelom - immunosuppressiva - imnovid i kombination med bortezomib og dexamethason er indiceret til behandling af voksne patienter med myelomatose, som har modtaget mindst én tidligere behandling opskrift herunder lenalidomid. imnovid i kombination med dexamethason er indiceret til behandling af voksne patienter med recidiverende og ildfaste myelomatose, der har modtaget mindst to forudgående behandlingsregimer, herunder både lenalidomid og bortezomib, og har vist sygdomsprogression på den sidste terapi.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Æggestokkene neoplasmer - antineoplastiske midler - Æggestokkene cancerlynparza er angivet som monoterapi til:vedligeholdelse behandling af voksne patienter med avanceret (figo faser iii og iv) brca1/2-muterede (germline og/eller somatiske) high-grade epitelial ovariecancer, æggeleder eller primær peritoneal cancer, der er i reaktion (hel eller delvis) efter afslutningen af første linje platin-baseret kemoterapi. 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 og 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patienter bør have, der tidligere er blevet behandlet med en antracyklin og en taxane i (neo)adjuvans eller metastatisk indstilling, medmindre patienter, der ikke var egnet til disse behandlinger (se afsnit 5. patienter med hormon receptor (hr)-positiv brystkræft bør også have udviklet sig på eller efter forudgående endokrine terapi, eller anses uegnet til at endokrine terapi. 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.

Đan Mạch - Tiếng Đan Mạch - Lægemiddelstyrelsen (Danish Medicines Agency)

medac, gesellschaft für klinische spezialpräparate mbh - methotrexat - injektionsvæske, opløsning i fyldt injektionssprøjte - 50 mg/ml

Đan Mạch - Tiếng Đan Mạch - Lægemiddelstyrelsen (Danish Medicines Agency)

2care4 aps - methotrexatnatrium - tabletter - 2,5 mg

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - rektal fistel - immunosuppressiva - alofisel er indiceret til behandling af komplekse endetarmsåbning fistler hos voksne patienter med ikke-aktive/mildt aktiv luminal crohn ' s sygdom, når fistler har vist et utilstrækkeligt respons på mindst én konventionelle eller biologiske terapi. alofisel bør anvendes efter konditionering af fistler.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - andre antineoplastiske midler - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastiske midler - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna er indiceret til behandling af voksne og pædiatriske patienter med tab af synet på grund af arvelig retinal dystrofi skyldes bekræftet biallelic rpe65 mutationer, og som har tilstrækkelig levedygtige celler retinal.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - muskelatrofi, spinal - andre midler mod forstyrrelser i muskel-skeletsystemet - zolgensma er indiceret til behandling af patienter med 5q spinal muskelatrofi (sma) med en bi-allelerne mutation i smn1-genet, og en klinisk diagnose af sma type 1, orpatients med 5q sma med en bi-allelerne mutation i smn1-genet, og op til 3 kopier af smn2-gen.

Liên Minh Châu Âu - Tiếng Đan Mạch - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - leukæmi, myeloid, akut - antineoplastiske midler - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.