Europese Unie - Nederlands - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - immunosuppressiva - rheumatoid arthritis  amgevita 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. de behandeling van ernstige, actieve en progressieve reumatoïde artritis bij volwassenen die niet eerder behandeld zijn met methotrexaat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita vermindert de snelheid van progressie van gewrichtsschade, zoals gemeten door de x-ray en verbetert de fysieke functie, indien gegeven in combinatie met methotrexaat. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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). amgevita kan worden gegeven als monotherapie in geval van intolerantie voor methotrexaat of wanneer voortgezette behandeling met methotrexaat als ongepast (voor de werkzaamheid in monotherapie zie sectie 5. adalimumab is niet onderzocht bij patiënten jonger dan 2 jaar. enthesitis-related arthritis amgevita 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 spondyloarthritis ankylosing spondylitis (as) amgevita 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 as amgevita 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. psoriatic arthritis amgevita 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. amgevita vermindert 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 verbetert de fysieke functie. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita 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) amgevita 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 disease amgevita 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 disease amgevita 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 colitis amgevita 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. uveitis amgevita 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 uveitis amgevita 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.

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

pharmagal bio spol. s.r.o. - geinactiveerd duiven paramyxovirus type 1, stam 988m-ca - emulsie voor injectie - geinactiveerd duiven paramyxovirus type 1, stam 988m-ca e/flacon, - pigeon paramyxovirus vaccine - duiven

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - amoxicilline 3-water 574 mg/flacon samenstelling overeenkomend met ; amoxicilline 0-water 500 mg/flacon - poeder voor orale suspensie - aardbeiensmaakstof ; acesulfaam kalium (e 950) ; crospovidon (e 1202) ; maltodextrine ; maÏszetmeel, gemodificeerd (modificatie onbekend ; saccharoide natrium x-water (e 954) ; siliciumdioxide (e 551) ; siliciumdioxide, gehydrateerd (e 551) ; xanthaangom (e 415), aardbeiensmaakstof ; acesulfaam kalium (e 950) ; crospovidon (e 1202) ; maltodextrine ; maÏszetmeel, gemodificeerd (modificatie onbekend, (e 1450) ; saccharoide natrium x-water (e 954) ; siliciumdioxide (e 551) ; siliciumdioxide, gehydrateerd (e 551) ; xanthaangom (e 415), - amoxicillin

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

orion corporation orionintie 1 sf-02200 espoo (finland) - budesonide 160 µg/dosis ; formoterolfumaraat 2-water 4,5 µg/dosis samenstelling overeenkomend met ; formoterol 3,7 µg/dosis - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - methylprednisolon 16 mg/stuk - tablet - lactose 1-water ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; saccharose ; siliciumdioxide (e 551), lactose 1-water ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; saccharose ; siliciumdioxide (e 551), - methylprednisolone

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - methylprednisolon 4 mg/stuk - tablet - lactose 1-water ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; saccharose ; siliciumdioxide (e 551), lactose 1-water ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; saccharose ; siliciumdioxide (e 551), - methylprednisolone

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - minocycline hydrochloride 2-water 115,85 mg/stuk samenstelling overeenkomend met ; minocycline 100 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - minocycline

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - minocycline hydrochloride 2-water 57,93 mg/stuk samenstelling overeenkomend met ; minocycline 50 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; povidon k 25 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - minocycline

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

eurogenerics n.v. heizel esplanade b22 1020 brussel (belgiË) - zolpidemtartraat - bruistablet - dinatriumwaterstofcitraat 1,5 water ; grapefruit aroma 502924 tp0551 ; grapefruit oil (ri) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maltodextrine ; monosodium citrate (e 331) (ri) ; natriumcarbonaat 0-water (e 500 (i)) ; natriumwaterstofcarbonaat (e 500 (ii)) ; polyethyleenglycol (e 1521) ; povidon (e 1201) ; saccharoide natrium x-water (e 954), - zolpidem

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm ltd - midostaurin - leukemia, myeloid, acute; mastocytosis - antineoplastische middelen - rydapt is aangegeven:in combinatie met de standaard daunorubicine en cytarabine inductie en een hoge dosis cytarabine consolidatie chemotherapie, en voor de patiënten een complete respons gevolgd door rydapt één agent onderhoud therapie bij volwassen patiënten met nieuw gediagnosticeerd met acute myeloïde leukemie (aml) die flt3-mutatie positief (zie hoofdstuk 4. 2);als monotherapie voor de behandeling van volwassen patiënten met agressieve systemische mastocytose (asm), systemische mastocytose met geassocieerde hematologische neoplasma (sm ahn), of mast-cel leukemie (mcl).