Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

dechra regulatory b.v. - maropitant - maagdarmkanaal en metabolisme, andere anti-emetica - cats; dogs - honden:voor de behandeling en preventie van misselijkheid veroorzaakt door chemotherapyfor de preventie van braken met uitzondering van die veroorzaakt door beweging sicknessfor de behandeling van braken, in combinatie met andere ondersteunende measuresfor de preventie van peri-operatieve misselijkheid en braken en de verbetering van het herstel van de narcose na gebruik van de µ-opiaat receptor agonist morphinecats:voor de preventie van braken en de vermindering van misselijkheid, met uitzondering van die veroorzaakt door beweging sicknessfor de behandeling van braken, in combinatie met andere ondersteunende maatregelen.

Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna is geïndiceerd voor de behandeling van volwassen en pediatrische patiënten met verlies van het gezichtsvermogen door erfelijke retinale dystrofie veroorzaakt door bevestigd biallelic rpe65 mutaties, en die over voldoende levensvatbaar retinale cellen.

Բելգիա - հոլանդերեն - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

opella healthcare belgium sa-nv - triamcinolonacetonide 0,055 g/100 g - neusspray, suspensie - 55 µg/dose - triamcinolonacetonide 0.55 mg/g - triamcinolone

Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - ciclesonide - ademhalingswegen, andere geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, vluchtige stoffen - paarden - voor de vermindering van klinische symptomen van ernstige paarden astma (voorheen bekend als het recurrent obstructie van de luchtweg – (rao), zomer weide geassocieerd recidiverende luchtweg obstructie – (spa-rao)).

Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppressiva - rheumatoid arthritisyuflyma in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab is aangetoond dat het verminderen van de snelheid van progressie van gewrichtsschade, zoals gemeten door de x-ray en verbetering van fysiek functioneren, indien gegeven in combinatie met methotrexaat. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab is niet onderzocht bij patiënten jonger dan 2 jaar. enthesitis-related arthritisyuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asyuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psoriatic arthritisyuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab is aangetoond dat het verminderen van de snelheid van progressie van perifere gewrichtsschade, zoals gemeten door de x-ray bij patiënten met polyarticulaire symmetrische subtypen van de ziekte (zie hoofdstuk 5. 1) en aan het verbeteren van de fysieke functie. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 en 5. crohn’s diseaseyuflyma is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaseyuflyma is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitisyuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisyuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisyuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitisyuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Նիդերլանդեր - հոլանդերեն - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sapropterinedihydrochloride 100 mg/stuk samenstelling overeenkomend met ; sapropterine 76,8 mg/stuk - oplosbare tablet - ascorbinezuur (l-) (e 300) ; crospovidon (e 1202) ; mannitol (d-) (e 421) ; maÏszetmeel, gepregelatineerd ; natriumstearylfumaraat ; riboflavine (e 101), ascorbinezuur (l-) (e 300) ; crospovidon (e 1202) ; mannitol (d-) (e 421) ; maÏszetmeel, gepregelatineerd ; natriumstearylfumaraat ; riboflavine

Նիդերլանդեր - հոլանդերեն - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sapropterinedihydrochloride 100 mg/stuk samenstelling overeenkomend met ; sapropterine 76,8 mg/stuk - oplosbare tablet - ascorbinezuur (l-) (e 300) ; crospovidon (e 1202) ; mannitol (d-) (e 421) ; maÏszetmeel, gepregelatineerd ; natriumstearylfumaraat ; riboflavine (e 101), ascorbinezuur (l-) (e 300) ; crospovidon (e 1202) ; mannitol (d-) (e 421) ; maÏszetmeel, gepregelatineerd ; natriumstearylfumaraat ; riboflavine

Բելգիա - հոլանդերեն - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

cheplapharm arzneimittel gmbh - isosorbidedinitraat 1 mg/ml - oplossing voor injectie - 1 mg/ml - isosorbidedinitraat 1 mg/ml - isosorbide dinitrate

Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - difelikefalin - pruritus - alle andere therapeutische producten - kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.

Եվրոպական Միություն - հոլանդերեն - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidiniumbromide - longaandoening, chronisch obstructief - geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, - geïndiceerd als een onderhoudsbehandeling met bronchusverwijders om de symptomen te verlichten bij volwassen patiënten met chronische obstructieve longziekte (copd).