Xtandi Europese Unie - Nederlands - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamide - prostaatnoplasma - endocriene therapie - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Abiraterone Mylan Europese Unie - Nederlands - EMA (European Medicines Agency)

abiraterone mylan

mylan ireland limited - abirateronacetaat - prostaatnoplasma - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Lynparza Europese Unie - Nederlands - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - ovariële neoplasma's - antineoplastische middelen - de eierstokken cancerlynparza is geïndiceerd als monotherapie voor het onderhoud behandeling van volwassen patiënten met gevorderde (figo stadia iii en iv) brca1/2-gemuteerd (kiembaan en/of somatische) hoogwaardige epitheliale eierstok, eileider of primaire peritoneale kanker die in de respons (volledige of gedeeltelijke) na de voltooiing van de eerste lijn op platina gebaseerde chemotherapie. 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 en 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. moeten patiënten die eerder behandeld zijn met een anthracycline en een taxane in de (neo)adjuvant of gemetastaseerd instelling, tenzij de patiënten werden niet geschikt voor deze behandelingen (zie sectie 5. patiënten met een hormoon-receptor (hr)-positieve borstkanker moet ook vooruitgang hebben geboekt op of na voorafgaande endocriene therapie, of worden beschouwd als ongeschikt voor endocriene therapie. 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.

Abiraterone Accord Europese Unie - Nederlands - EMA (European Medicines Agency)

abiraterone accord

accord healthcare s.l.u. - abirateronacetaat - prostaatnoplasma - endocriene therapie - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Abiraterone Krka Europese Unie - Nederlands - EMA (European Medicines Agency)

abiraterone krka

krka, d.d., novo mesto - abirateronacetaat - prostaatnoplasma - endocriene therapie - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Degarelix Accord Europese Unie - Nederlands - EMA (European Medicines Agency)

degarelix accord

accord healthcare s.l.u. - degarelix acetate - prostaatnoplasma - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Oberon® Nederland - Nederlands - myHealthbox

oberon®

bayer ag - suspensie concentraat - 240 g/l spiromesifen

Pregnyl 5000 I.E., poeder en oplosmiddel voor oplossing voor injectie Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pregnyl 5000 i.e., poeder en oplosmiddel voor oplossing voor injectie

dr. fisher farma b.v. - humaan choriongonadotrofine; - poeder en oplosmiddel voor oplossing voor injectie - chorionic gonadotropin

Gonapeptyl Depot, poeder en oplosmiddel voor suspensie voor injectie 3,75 mg Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

gonapeptyl depot, poeder en oplosmiddel voor suspensie voor injectie 3,75 mg

dr. fisher farma b.v. schutweg 23 8243 pc lelystad - triptorelineacetaat 0-water samenstelling overeenkomend met ; triptoreline - poeder en oplosmiddel voor suspensie voor injectie - dextraan 70 ; melkzuur(d,l)-glycolzuur copolymeer ; natriumchloride ; natriumdiwaterstoffosfaat 2-water (e 339) ; natriumhydroxide (e 524) ; polysorbaat 80 (e 433) ; propyleenglycoldicaprylocapraat ; water voor injectie, - triptorelin

Leuproreline Lutrate Depot 22,5 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

leuproreline lutrate depot 22,5 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte

gp pharm - leuprorelineacetaat samenstelling overeenkomend met ; leuproreline - poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte - carmellose natrium (e 466) ; mannitol (d-) (e 421) ; natriumhydroxide (e 524) ; poly(dl-melkzuur) ; polysorbaat 80 (e 433) ; triethylcitraat (e 1505) ; water voor injectie ; zoutzuur (e 507), - leuprorelin