האיחוד האירופי - הולנדית - EMA (European Medicines Agency)

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.

האיחוד האירופי - הולנדית - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - carcinoom, niet-kleincellige long - andere antineoplastische middelen, proteïne kinase remmers - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

הולנד - הולנדית - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

norbrook laboratories ltd. (station works) - amoxicilline 3-water; clavulaanzuur - tablet - amoxicillin and beta-lactamase inhibitor

הולנד - הולנדית - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

norbrook laboratories ltd. (station works) - amoxicilline 3-water; clavulaanzuur - tablet - amoxicillin and beta-lactamase inhibitor

הולנד - הולנדית - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

norbrook laboratories ltd. (station works) - amoxicilline 3-water; amoxicilline 0-water; kaliumclavulanaat; clavulaanzuur - tablet - amoxicillin and beta-lactamase inhibitor

וייטנאם - ויאטנמית - BỘ Y TẾ (CỤC QUẢN LÝ DƯỢC)

novartis (singapore) pte ltd - levetiracetam - viên nén bao phim - 750mg

בלגיה - הולנדית - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

amdipharm ltd. - imipraminehydrochloride 10 mg - omhulde tablet - 10 mg - imipraminehydrochloride 10 mg - imipramine

בלגיה - הולנדית - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

amdipharm ltd. - imipraminehydrochloride 25 mg - omhulde tablet - 25 mg - imipraminehydrochloride 25 mg - imipramine

האיחוד האירופי - הולנדית - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemie, myeloïde, acuut - antineoplastische middelen - xospata is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverende of refractaire acute myeloïde leukemie (aml) met een flt3-mutatie.

האיחוד האירופי - הולנדית - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemische preparaten - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).