Den Europæiske Union - dansk - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastiske midler - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

ceva santé animale - torasemide - high-ceiling diuretics, sulfonamider, almindelig - hunde - til behandling af kliniske symptomer, der er relateret til kongestiv hjerteinsufficiens, i hunde, herunder lungeødem.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - Æggestokkene neoplasmer - antineoplastiske midler - rubraca is indicated as monotherapy 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. rubraca er angivet som monoterapi til vedligeholdelse behandling af voksne patienter med platin-følsomme gået high-grade epitelial ovariecancer, æggeleder, eller primær peritoneal cancer, der er i reaktion (hel eller delvis) til platin-baseret kemoterapi.

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastiske midler - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

tmc pharma services ltd. - gadofosveset trinatrium - magnetisk resonans angiografi - kontrastmedier - dette lægemiddel er kun til diagnostisk brug. ablavar er indiceret til kontrastforstærket magnetisk resonans angiografi (ce-mra) til visualisering af abdominale eller lemmer fartøjer i kun for voksne, med mistanke om eller kendte vaskulær sygdom.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - linaclotide - irritabelt tarmsyndrom - lægemidler til forstoppelse - constella er indiceret til symptomatisk behandling af moderat til svær irritabel tarmsyndrom med forstoppelse (ibs-c) hos voksne.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - human papillomavirus type 6 l1-protein, humant papillomvirus type 11 l1-protein, human papillomavirus type 16 l1-protein, humant papillomvirus type 18 l1-protein - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vacciner - gardasil er en vaccine til brug i en alder af 9 år til forebyggelse af:premalignant genitale læsioner (livmoderhals, vulva og vaginal), premalignant anal læsioner, livmoderhalskræft og anal kræft kausalt relateret til visse kræftfremkaldende humant papillomvirus (hpv) typer;genital vorter (condyloma acuminata) kausalt relateret til specifikke hpv-typer. se afsnit 4. 4 og 5. 1 for vigtige oplysninger om de data, der understøtter denne indikation. brugen af gardasil skal være i overensstemmelse med de officielle anbefalinger.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - humant papillomavirusvaccine [typer 6, 11, 16, 18, 31, 33, 45, 52, 58] (rekombinant, adsorberet) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papillomvirus vacciner - gardasil 9 er indiceret til aktiv immunisering af personer fra en alder af 9 år mod følgende hpv-sygdomme:premalignant læsioner og kræft, der påvirker cervix, vulva, vagina og anus, der er forårsaget af hpv-vaccine typesgenital vorter (condyloma acuminata), der er forårsaget af de specifikke hpv-typer. se afsnit 4. 4 og 5. 1 for vigtige oplysninger om de data, der understøtter disse betegnelser. brugen af gardasil 9 skal være i overensstemmelse med de officielle anbefalinger.