Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunosuppressiva - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriatica arthritiscosentyx, alleen of in combinatie met methotrexaat (mtx), is geïndiceerd voor de behandeling van actieve artritis psoriatica bij volwassen patiënten wanneer de respons op eerdere disease modifying anti-reumatische drug (dmard) therapie is dat er onvoldoende. axiale spondyloarthritis (axspa)spondylitis ankylopoetica (as, radiografische axiale spondyloarthritis)cosentyx is geïndiceerd voor de behandeling van actieve spondylitis ankylopoetica bij volwassenen die onvoldoende gereageerd op conventionele therapie. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - artritis, reumatoïde - immunosuppressiva - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant kan als monotherapie of in combinatie met methotrexaat worden gebruikt. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

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

ipca produtos farmaceuticos unipessoal lda rua jose nogueira vaz, lote 104-lj esq 2625-099 povoa de santa iria (portugal) - donepezilhydrochloride 1-water samenstelling overeenkomend met ; ; donepezilhydrochloride 10 mg/stuk ; samenstelling overeenkomend met donepezil 9,12 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; maÏszetmeel, gedroogd ; natriumstearylfumaraat ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; maÏszetmeel, gedroogd ; natriumstearylfumaraat ; talk (e 553 b) ; titaandioxide (e 171), - donepezil

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

ipca produtos farmaceuticos unipessoal lda rua jose nogueira vaz, lote 104-lj esq 2625-099 povoa de santa iria (portugal) - donepezilhydrochloride 1-water samenstelling overeenkomend met ; ; donepezilhydrochloride 5 mg/stuk ; samenstelling overeenkomend met donepezil 4,56 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 6000 ; maÏszetmeel, gedroogd ; natriumstearylfumaraat ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 6000 ; maÏszetmeel, gedroogd ; natriumstearylfumaraat ; talk (e 553 b) ; titaandioxide (e 171), - donepezil

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

ipca produtos farmaceuticos unipessoal lda rua jose nogueira vaz, lote 104-lj esq 2625-099 povoa de santa iria (portugal) - levocetirizinedihydrochloride 5 mg/stuk samenstelling overeenkomend met ; levocetirizine 4,2 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 400 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 400 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - levocetirizine

Europese Unie - Nederlands - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - multiple sclerose - selectieve immunosuppressiva - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Europese Unie - Nederlands - EMA (European Medicines Agency)

teva pharma b.v. - mycofenolaat mofetil - graft rejection - immunosuppressiva - mycofenolaat mofetil teva is geïndiceerd in combinatie met ciclosporine en corticosteroïden voor de profylaxe van acute transplantaatafstoting bij patiënten die allogene nier-, hart- of levertransplantaties ontvangen..

Europese Unie - Nederlands - EMA (European Medicines Agency)

teva b.v. - mycofenolaat mofetil - graft rejection - immunosuppressiva - myfenax is geïndiceerd in combinatie met ciclosporine en corticosteroïden voor de profylaxe van acute transplantaatafstoting bij patiënten die allogene nier-, hart- of levertransplantaties ontvangen..

Europese Unie - Nederlands - EMA (European Medicines Agency)

almirall, s.a. - eflornithine - hirsutisme - andere dermatologische preparaten - behandeling van gezichtshirsutisme bij vrouwen.

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

ipca produtos farmaceuticos unipessoal lda rua jose nogueira vaz, lote 104-lj esq 2625-099 povoa de santa iria (portugal) - hydrochloorthiazide 12,5 mg/stuk ; losartan kalium 50 mg/stuk samenstelling overeenkomend met ; losartan 45,9 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; chinolinegeel aluminiumlak (e 104) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gedroogd ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; chinolinegeel aluminiumlak (e 104) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gedroogd ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - losartan and diuretics