Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastische middelen - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Belgium - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline pharmaceuticals sa-nv - ranitidinehydrochloride 28 mg/ml - eq. ranitidine 25 mg/ml - oplossing voor injectie - 50 mg/2 ml - ranitidinehydrochloride 28 mg/ml - ranitidine

Belgium - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline pharmaceuticals sa-nv - ranitidinehydrochloride 16,8 mg/ml - eq. ranitidine 15 mg/ml - siroop - 150 mg/10 ml - ranitidinehydrochloride 16.8 mg/ml - ranitidine

Belgium - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline pharmaceuticals sa-nv - ranitidinehydrochloride 168 mg - eq. ranitidine 150 mg - filmomhulde tablet - 150 mg - ranitidinehydrochloride 168 mg - ranitidine

Belgium - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline pharmaceuticals sa-nv - ranitidinehydrochloride 168 mg - eq. ranitidine 150 mg - bruistablet - 150 mg - ranitidinehydrochloride 168 mg - ranitidine

Belgium - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline pharmaceuticals sa-nv - ranitidinehydrochloride 336 mg - eq. ranitidine 300 mg - bruistablet - 300 mg - ranitidinehydrochloride 336 mg - ranitidine

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

bayer ag - riociguat - hypertensie, pulmonair - antihypertensiva voor pulmonale arteriële hypertensie - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. de werkzaamheid is aangetoond in een pak van de bevolking inclusief de oorzaken van idiopathische of erfelijke pah of pah geassocieerd met bindweefselaandoeningen. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

eli lilly nederland b.v. - ramucirumab - maagneoplasma - antineoplastische middelen - maag-cancercyramza in combinatie met paclitaxel is geïndiceerd voor de behandeling van volwassen patiënten met gevorderde maagkanker of gastro-oesofageale junctie adenocarcinoom met progressie van de ziekte na voorafgaande platinum en fluoropyrimidine chemotherapie. cyramza monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met gevorderde maagkanker of gastro-oesofageale junctie adenocarcinoom met progressie van de ziekte na voorafgaande platina of fluoropyrimidine chemotherapie, voor wie de behandeling in combinatie met paclitaxel is niet geschikt. colorectale cancercyramza, in combinatie met folfiri (irinotecan, folinezuur en 5‑fluorouracil), is geïndiceerd voor de behandeling van volwassen patiënten met gemetastaseerde colorectale kanker (mcrc) met progressie van de ziekte op of na voorafgaande behandeling met bevacizumab, oxaliplatine en een fluoropyrimidine. non-small cell lung cancercyramza in combinatie met docetaxel is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderde of gemetastaseerde niet-kleincellige longkanker met progressie van de ziekte na platinum gebaseerde chemotherapie. hepatocellulair carcinomacyramza monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met gevorderd of niet operabel hepatocellulair carcinoom bij wie een serum alpha-foetoproteïne (afp) van ≥ 400 ng/ml en die eerder werden behandeld met sorafenib.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

glaxosmithkline dungarvan limited - esomeprazol - gastro-oesofageale reflux - proton pomp remmers - nexium control is geïndiceerd voor de kortdurende behandeling van refluxklachten (bijv. brandend maagzuur en zure oprispingen) bij volwassenen.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv archimedesweg 2 2333 cn leiden - fenytoÏne 92 mg/stuk - tablet - lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; povidon (e 1201) ; talk (e 553 b), lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat (e468) ; povidon (e 1201) ; talk (e 553 b), - phenytoin