Europos Sąjunga - danų - EMA (European Medicines Agency)

merck europe b.v.  - follitropin alfa, lutropin alfa - infertilitet, kvinde - køn hormoner og modulatorer af den genitale system, - pergoveris er indiceret til stimulation af follikulære udvikling hos kvinder med alvorlige luteiniserende-hormon (lh) og follikelstimulerende-hormon mangel. i kliniske forsøg, disse patienter blev defineret ved en endogen serum lh niveau < 1. 2 ie / l.

Europos Sąjunga - danų - EMA (European Medicines Agency)

biopartners gmbh - somatropin - turner syndrome; dwarfism, pituitary - hypofysiske og hypotalamiske hormoner og analoger - pædiatrisk poulationlong sigt behandling af børn (fra 2 til 11 år) og unge (12 til 18 år) med vækstforstyrrelser på grund af en utilstrækkelig sekretion af normal endogen vækst hormon. behandling af korte statur i børn med turner syndrom, bekræftet af kromosom-analyse. behandling af væksthæmning hos præpubertale børn med kronisk nedsat nyrefunktion. voksen patientsreplacement terapi hos voksne med udtalt væksthormon mangel af enten barndom - eller voksen-debut ætiologi. patienter med svær væksthormon-mangel i voksenalderen er defineret som patienter med kendt hypothalamus-hypofyse-patologi og mindst et yderligere kendt mangel af et hypofysehormon, der ikke bliver prolaktin. disse patienter bør gennemgå en enkelt dynamiske test med henblik på at diagnosticere eller udelukke en væksthormon-mangel. hos patienter med barndommen-debut isoleret væksthormon-mangel (ingen tegn på hypothalamus-hypofyse-sygdom eller kraniel bestråling), to dynamiske tests bør anbefales, undtagen for dem, der har lave insulin-like growth factor-1 (igf-1) koncentrationer (< 2 standard afvigelse score (sds)), der kan anses for en test. cut-off point af den dynamiske test bør være strenge.

Europos Sąjunga - danų - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetat - prostatiske neoplasmer - 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.

Europos Sąjunga - danų - EMA (European Medicines Agency)

chemical works of gedeon richter plc. (gedeon richter plc.) - ganirelix acetate - reproductive techniques, assisted; ovulation induction; infertility, female - hypofysiske og hypotalamiske hormoner og analoger - prevention of premature luteinising hormone (lh) surges in women undergoing controlled ovarian hyperstimulation (coh) for assisted reproduction techniques (art).

Europos Sąjunga - danų - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - parathyreoideahormon - hypoparathyreoidisme - calciumhomeostase - natpar er indiceret som supplerende behandling af voksne patienter med kronisk hypoparathyroidisme, som ikke kan kontrolleres tilstrækkeligt med standardbehandling alene.

Europos Sąjunga - danų - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - prostatiske neoplasmer - endokrine terapi - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Europos Sąjunga - danų - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - prostatiske neoplasmer - endokrine terapi - firmagon 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.

Europos Sąjunga - danų - EMA (European Medicines Agency)

n.v. organon - nomegestrol acetat, østradiol - svangerskabsforebyggelse - køn hormoner og modulatorer af den genitale system, - oral prævention.

Europos Sąjunga - danų - 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.

Europos Sąjunga - danų - EMA (European Medicines Agency)

shionogi b.v. - ospemifen - menopausen - køn hormoner og modulatorer af den genitale system, - senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (vva) in post-menopausal women.