Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplasmata van de borst - antineoplastische middelen - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

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)

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)

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)

boehringer ingelheim international gmbh - idarucizumab - bloeding - alle andere therapeutische producten - praxbind is een specifieke omkering agent voor dabigatran en is aangegeven bij volwassen patiënten die werden behandeld met pradaxa (dabigatran etexilate) wanneer een snelle omkering van de anticoagulerende effecten is niet nodig, voor een spoedoperatie/dringende procedures;in levensbedreigende of ongecontroleerde bloeding.

Europese Unie - Nederlands - EMA (European Medicines Agency)

bayer ag - aflibercept - wet macular degeneration; macular edema; diabetes complications - ophthalmologica - eylea is geïndiceerd bij volwassenen voor de behandeling van:neovascular (natte) leeftijdsgebonden maculaire degeneratie (amd);slechtziendheid als gevolg van maculair oedeem, secundair aan retinale veneuze occlusie (tak rvo of centrale rvo);visuele handicap vanwege diabetisch macula-oedeem (dme);visuele handicap vanwege bijziend choroidale neovascularisation (bijziend cnv).

Europese Unie - Nederlands - EMA (European Medicines Agency)

viatris limited - aflibercept - macular edema; retinal vein occlusion; diabetic retinopathy; myopia, degenerative; diabetes complications - ophthalmologica - yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (amd) (see section 5. 1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo) (see section 5. 1),visual impairment due to diabetic macular oedema (dme) (see section 5. 1),visual impairment due to myopic choroidal neovascularisation (myopic cnv) (see section 5.