Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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). vegzelma 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 vegzelma in combination with capecitabine. raadpleeg sectie 5 voor meer informatie over her2-status. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - ranibizumab - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - ophthalmologica - lucentis is geïndiceerd bij volwassenen voor:de behandeling van neovascular (natte) leeftijdsgebonden maculaire degeneratie (amd)de behandeling van slechtziendheid als gevolg choroidale neovascularisation (cnv)de behandeling van slechtziendheid als gevolg diabetisch macula-oedeem (dme)de behandeling van slechtziendheid als gevolg van maculair oedeem, secundair aan retinale veneuze occlusie (tak rvo of centrale rvo).

Europese Unie - Nederlands - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxysmale - selectieve immunosuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplasmata van de borst - antineoplastische middelen - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Europese Unie - Nederlands - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - ophthalmologica - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Europese Unie - Nederlands - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - ophthalmologica - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Europese Unie - Nederlands - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - ophthalmologica - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - tocilizumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; cytokine release syndrome; giant cell arteritis; covid-19 virus infection - immunosuppressiva - roactemra, in combinatie met methotrexaat (mtx), is geïndiceerd voor de behandeling van ernstige, actieve en progressieve reumatoïde artritis (ra) bij volwassenen die niet eerder behandeld werden met mtx. de behandeling van matige tot ernstige actieve ra bij volwassen patiënten die onvoldoende gereageerd op, of die intolerant waren tot eerdere therapie met één of meerdere disease-modifying anti-reumatische middelen (dmard ' s) of tumor necrose factor (tnf) - antagonisten. bij deze patiënten, roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast. roactemra is aangetoond dat het verminderen van de snelheid van progressie van gewrichtsschade, zoals gemeten door de x-ray en verbetering van fysiek functioneren als gegeven in combinatie met methotrexaat. roactemra is geïndiceerd voor de behandeling van actieve systemische juveniele idiopathische artritis (sjia) in patiënten van 1 jaar en ouder, die onvoldoende hebben gereageerd op eerdere therapie met nsaid ' s en systemische corticosteroïden. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer de behandeling met mtx is ongepast) of in combinatie met mtx. roactemra in combinatie met methotrexaat (mtx) is geïndiceerd voor de behandeling van juveniele idiopathische polyarthritis (pjia; reumafactor positief of negatief en uitgebreid oligoarthritis) bij patiënten van 2 jaar en ouder, die onvoldoende hebben gereageerd op eerdere behandeling met mtx. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast. roactemra is geïndiceerd voor de behandeling van giant cell arteritis (gca) bij volwassen patiënten. roactemra, in combinatie met methotrexaat (mtx), is geïndiceerd voor:de behandeling van ernstige, actieve en progressieve reumatoïde artritis (ra) bij volwassenen die niet eerder behandeld werden met mtx. de behandeling van matige tot ernstige actieve ra bij volwassen patiënten die onvoldoende gereageerd op, of die intolerant waren tot eerdere therapie met één of meerdere disease-modifying anti-reumatische middelen (dmard ' s) of tumor necrose factor (tnf) - antagonisten. bij deze patiënten, roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra is geïndiceerd voor de behandeling van actieve systemische juveniele idiopathische artritis (sjia) bij patiënten van 2 jaar en ouder, die onvoldoende hebben gereageerd op eerdere therapie met nsaid ' s en systemische corticosteroïden. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer de behandeling met mtx is ongepast) of in combinatie met mtx. roactemra in combinatie met methotrexaat (mtx) is geïndiceerd voor de behandeling van juveniele idiopathische polyarthritis (pjia; reumafactor positief of negatief en uitgebreid oligoarthritis) bij patiënten van 2 jaar en ouder, die onvoldoende hebben gereageerd op eerdere behandeling met mtx. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast. roactemra is geïndiceerd voor de behandeling van chimerisch antigeen receptor (auto) t-cel-veroorzaakt ernstige of levensbedreigende cytokine release syndroom (crs) bij volwassenen en pediatrische patiënten van 2 jaar en ouder. roactemra, in combinatie met methotrexaat (mtx), is geïndiceerd voor:de behandeling van ernstige, actieve en progressieve reumatoïde artritis (ra) bij volwassenen die niet eerder behandeld werden met mtx. de behandeling van matige tot ernstige actieve ra bij volwassen patiënten die onvoldoende gereageerd op, of die intolerant waren tot eerdere therapie met één of meerdere disease-modifying anti-reumatische middelen (dmard ' s) of tumor necrose factor (tnf) - antagonisten. bij deze patiënten, roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra is geïndiceerd voor de behandeling van actieve systemische juveniele idiopathische artritis (sjia) bij patiënten van 2 jaar en ouder, die onvoldoende hebben gereageerd op eerdere therapie met nsaid ' s en systemische corticosteroïden. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer de behandeling met mtx is ongepast) of in combinatie met mtx. roactemra in combinatie met methotrexaat (mtx) is geïndiceerd voor de behandeling van juveniele idiopathische polyarthritis (pjia; reumafactor positief of negatief en uitgebreid oligoarthritis) bij patiënten van 2 jaar en ouder, die onvoldoende hebben gereageerd op eerdere behandeling met mtx. roactemra kan worden gegeven als monotherapie in geval van intolerantie voor mtx of wanneer voortgezette behandeling met mtx is ongepast. roactemra is geïndiceerd voor de behandeling van chimerisch antigeen receptor (auto) t-cel-veroorzaakt ernstige of levensbedreigende cytokine release syndroom (crs) bij volwassenen en pediatrische patiënten van 2 jaar en ouder.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - lymfoom, b-cel - antineoplastische middelen - polivy in combinatie met bendamustine en rituximab is geïndiceerd voor de behandeling van volwassen patiënten met recidiverende/refractaire diffuus grootcellig b-cel lymfoom (dlbcl) die geen kandidaat zijn voor een hematopoëtische stamceltransplantatie. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).