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

lydisilka

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - geslachtshormonen en modulatoren van het genitale systeem, - orale anticonceptie. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

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

evra

gedeon richter plc. - norelgestromin, ethinyl estradiol - anticonceptiemiddel - geslachtshormonen en modulatoren van het genitale systeem, - vrouwelijke anticonceptie. evra is bedoeld voor vrouwen van vruchtbare leeftijd. de veiligheid en werkzaamheid is vastgesteld bij vrouwen in de leeftijd van 18 tot 45 jaar.

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

drovelis

gedeon richter plc. - drospirenone, estetrol monohydrate - contraceptives, oral - geslachtshormonen en modulatoren van het genitale systeem, - oral contraceptive.

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.

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

sogroya

novo nordisk a/s - somapacitan - groei - hypofyse en hypothalamische hormonen en analogen - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

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

ryeqo

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoom - hypofyse en hypothalamische hormonen en analogen - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

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

yselty

theramex ireland limited - linzagolix choline - leiomyoom - hypofyse en hypothalamische hormonen en analogen - yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

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

senshio

shionogi b.v. - ospemifene - postmenopauze - geslachtshormonen en modulatoren van het genitale systeem, - senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (vva) in post-menopausal women.

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

bemfola

gedeon richter plc. - follitropine alfa - anovulatie - geslachtshormonen en modulatoren van het genitale systeem, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. in klinische studies deze patiënten werden gedefinieerd door een endogene serum lh gehalte < 1. 2 ie / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

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

ioa

n.v. organon - nomegestrol acetaat estradiol - anticonceptiemiddel - geslachtshormonen en modulatoren van het genitale systeem, - orale anticonceptie.