Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

zentiva k.s. u kabelovny 130 102 37 prague 10 (tsjechiË) - azacitidine 100 mg/flacon - poeder voor suspensie voor injectie - mannitol (d-) (e 421) ; stikstof (head space) (e 941)

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

centrafarm b.v. nieuwe donk 3 4879 ac etten leur - azacitidine 100 mg/flacon - poeder voor suspensie voor injectie - mannitol (d-) (e 421) ; stikstof (head space) (e 941)

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

azacitidine 25 mg/ml - poeder voor suspensie voor injectie - mannitol (d-) (e 421)

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

azacitidine 100 mg/flacon - poeder voor suspensie voor injectie - mannitol (d-) (e 421)

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - factor von willebrand 1200 ie; humane bloedstollingsfactor viii 500 ie - poeder en oplosmiddel voor oplossing voor injectie/infusie - 1200 iu - 500 iu - humane bloedstollingsfactor viii 500 ie; factor von willebrand 1200 ie - von willebrand factor and coagulation factor viii in combination

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - factor von willebrand 2400 ie; humane bloedstollingsfactor viii 1000 ie - poeder en oplosmiddel voor oplossing voor injectie/infusie - 2400 iu - 1000 iu - humane bloedstollingsfactor viii 1000 ie; factor von willebrand 2400 ie - von willebrand factor and coagulation factor viii in combination

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - humane bloedstollingsfactor viii 250 ie; factor von willebrand 600 ie - poeder en oplosmiddel voor oplossing voor injectie/infusie - 600 iu - 250 iu - humane bloedstollingsfactor viii 250 ie; factor von willebrand 600 ie - von willebrand factor and coagulation factor viii in combination

Uni Eropa - Belanda - EMA (European Medicines Agency)

holostem s.r.l - ex vivo geëxpandeerde autologe humane corneale epitheelcellen die stamcellen bevatten - stem cell transplantation; corneal diseases - ophthalmologica - behandeling van volwassen patiënten met matige tot ernstige limbal stam-cel-deficiëntie (gedefinieerd door de aanwezigheid van oppervlakkige hoornvlies neovascularisatie in ten minste twee hoornvlies kwadranten, met centrale hoornvlies betrokkenheid, en sterk verminderde gezichtsscherpte), unilaterale of bilaterale, vanwege fysieke of chemische oogbeschadigingen en/of brandwonden. een minimum van 1-2 mm2 onbeschadigde limbus is vereist voor biopsie.

Uni Eropa - Belanda - 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.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

eureco-pharma b.v. - levonorgestrel; - afleveringsysteem voor intra-uterien gebruik - plastic iud with progestogen