Europese Unie - Nederlands - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, thrombocytopenic, idiopathic - antihemorragica - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. corticosteroïden, immunoglobulinen). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. corticosteroïden, immunoglobulinen).

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, thrombocytopenic, idiopathic - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 en 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 en 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multiple sclerose, relapsing-remitting - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 en 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ranbaxy (uk) limited - valaciclovirhydrochloride samenstelling overeenkomend met; valaciclovir; - filmomhulde tablet - valaciclovir

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

porton biopharma limited lee view house, 13 south terrace t12 t0ct cork (ierland) - crisantaspase 10000 e/flacon - poeder voor oplossing voor injectie of infusie - azijnzuur (e 260) ; glucose 1-water ; natriumchloride ; natriumhydroxide (e 524)

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

brillpharma (ireland) limited iniscarra, main street rathcoole (ierland) - carbidopa 1-water 10,8 mg/stuk samenstelling overeenkomend met ; carbidopa 0-water 10 mg/stuk ; levodopa 100 mg/stuk - tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; indigokarmijn aluminiumlak (e 132) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; indigokarmijn aluminiumlak (e 132) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

brillpharma (ireland) limited iniscarra, main street rathcoole (ierland) - carbidopa 1-water 13,5 mg/stuk samenstelling overeenkomend met ; carbidopa 0-water 12,5 mg/stuk ; levodopa 50 mg/stuk - tablet - cellulose, microkristallijn (e 460(i)) ; chinolinegeel aluminiumlak (e 104) ; crospovidon (e 1202) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, cellulose, microkristallijn (e 460) ; chinolinegeel aluminiumlak (e 104) ; crospovidon (e 1202) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

brillpharma (ireland) limited iniscarra, main street rathcoole (ierland) - carbidopa 1-water 27 mg/stuk samenstelling overeenkomend met ; carbidopa 0-water 25 mg/stuk ; levodopa 100 mg/stuk - tablet - cellulose, microkristallijn (e 460(i)) ; chinolinegeel aluminiumlak (e 104) ; crospovidon (e 1202) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, cellulose, microkristallijn (e 460) ; chinolinegeel aluminiumlak (e 104) ; crospovidon (e 1202) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

brillpharma (ireland) limited iniscarra, main street rathcoole (ierland) - carbidopa 1-water 27 mg/stuk samenstelling overeenkomend met ; carbidopa 0-water 25 mg/stuk ; levodopa 250 mg/stuk - tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; indigokarmijn aluminiumlak (e 132) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; indigokarmijn aluminiumlak (e 132) ; magnesiumstearaat (e 470b) ; zetmeel, gepregelatineerd, - levodopa and decarboxylase inhibitor

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sigillata limited block a, 15 castleforbes square, sheriff street dublin 1 (ierland) - prasugrelhydrobromide samenstelling overeenkomend met ; prasugrel - filmomhulde tablet - cellulose, microkristallijn (e 460) ; glyceroldibehenaat ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; macrogol 3350 ; mannitol (d-) (e 421) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; sucrosestearaat (e 473) ; talk (e 553 b) ; titaandioxide (e 171), - prasugrel