Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

boiron (messimy) 2, avenue de l'ouest lyonnais 69510 messimy (frankrijk) - acalypha indica - toedieningsweg:oraal gebruik - , , , , , , , , , , , , , , , , , , , , , , , , , , , , - datum verstrekking handelsvergunning:12 maart 1999

Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

boiron (messimy) 2, avenue de l'ouest lyonnais 69510 messimy (frankrijk) - acalypha indica - globuli - , , , , , , , , , , , , , , , , , , , , , , , , , , , , - datum verstrekking handelsvergunning:14 mei 1999

Европейский союз - голландский - 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.

Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

le vet beheer b.v. - amoxicilline 3-water; amoxicilline 0-water - tablet - amoxicilline 3-water 287,5 mg/stuk; amoxicilline 0-water 250 mg/stuk, - amoxicillin - honden

Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

le vet beheer b.v. - amoxicilline 3-water; amoxicilline 0-water - tablet - amoxicilline 3-water 57,5 mg/stuk; amoxicilline 0-water 50 mg/stuk, - amoxicillin - honden; katten

Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

le vet beheer b.v. - amoxicilline 3-water; amoxicilline 0-water - tablet - amoxicilline 3-water 575 mg/stuk; amoxicilline 0-water 500 mg/stuk, - amoxicillin - honden

Европейский союз - голландский - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, chronisch - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. gelieve te verwijzen naar het ribavirine en boceprevir samenvattingen van de productkenmerken (smpcs) wanneer pegintron is om gebruikt te worden in combinatie met deze geneesmiddelen. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. pegintron in combinatie met ribavirine (bitherapy) is geïndiceerd voor de behandeling van chc infectie bij volwassen patiënten die eerder zijn onbehandeld met inbegrip van patiënten met een klinisch stabiele hiv co-infectie en bij volwassen patiënten die niet in een eerdere behandeling met interferon-alfa (gepegyleerd of niet-gepegyleerd) en ribavirine of interferon-alfa-monotherapie. interferon monotherapie, inclusief pegintron, is voornamelijk geïndiceerd in geval van intolerantie of contra-indicatie voor ribavirine. gelieve te verwijzen naar het ribavirine spc wanneer pegintron in combinatie met ribavirine. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. wanneer u besluit niet aan het uitstellen van de behandeling tot aan de volwassen leeftijd, is het belangrijk om te overwegen dat de combinatie therapie geïnduceerde een groeiremming dat kan onomkeerbaar zijn bij sommige patiënten. de beslissing om de behandeling moet worden gemaakt op een case-by-case basis. gelieve te verwijzen naar het ribavirine spc voor capsules of orale oplossing wanneer pegintron in combinatie met ribavirine.

Нидерланды - голландский - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

le vet b.v. - ivermectine - gel voor oraal gebruik - ivermectine 12 mg/g, - ivermectin - paarden

Бельгия - голландский - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alk-abello b.v. - venenum apis mellifera, extract 0,12 mg - poeder en oplosmiddel voor oplossing voor injectie - 120 µg - venenum apis mellifera, extract 0.12 mg - insects

Бельгия - голландский - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alk-abello b.v. - wespenvergif, extract 0,12 mg - poeder en oplosmiddel voor oplossing voor injectie - 120 µg - venenum vespula, extract 0.12 mg - insects