Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infecties - antivirale middelen voor systemisch gebruik - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-infecties - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta is geïndiceerd in combinatie met andere antiretrovirale geneesmiddelen voor de behandeling van een infectie met het humaan immunodeficiëntievirus 1 (hiv 1) bij volwassenen van 18 jaar of ouder. genotypische testen moet de leidraad zijn voor het gebruik van rezolsta.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv-infecties - antivirale middelen voor systemisch gebruik - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

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

medochemie limited constantinopelstreet 1-10 3011 limassol (cyprus) - modafinil 100 mg/stuk - tablet - aluminiummagnesiumsilicaat ; croscarmellose natrium (e 468) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon k 90 (e 1201) ; talk (e 553 b), - modafinil

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

lundbeck b.v. herikerbergweg 292 1101 ct amsterdam - citalopramhydrobromide samenstelling overeenkomend met ; ; citalopram 20 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; copovidon (e 1208) ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), - citalopram

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

lundbeck b.v. herikerbergweg 292 1101 ct amsterdam - citalopramhydrobromide samenstelling overeenkomend met ; ; citalopram 40 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; copovidon (e 1208) ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol 85 per cent (e 422) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; titaandioxide (e 171), - citalopram

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

lundbeck b.v. herikerbergweg 292 1101 ct amsterdam - citalopramhydrochloride 44,48 mg/ml samenstelling overeenkomend met ; citalopram 40 mg/ml - druppels voor oraal gebruik, oplossing - ethanol 76 mg/ml ; hydroxyethylcellulose ; methylparahydroxybenzoaat (e 218) ; propylparahydroxybenzoaat ; water, gezuiverd, ethanol 76 mg/ml ; hydroxyethylcellulose ; methylparahydroxybenzoaat (e 218) ; propylparahydroxybenzoaat (e 216) ; water, gezuiverd, - citalopram

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

bmodesto b.v. minervaweg 2 8239 dl lelystad - citalopramhydrochloride samenstelling overeenkomend met ; citalopram - druppels voor oraal gebruik, oplossing - ethanol ; hydroxyethylcellulose ; methylparahydroxybenzoaat (e 218) ; propylparahydroxybenzoaat (e 216) ; water, gezuiverd, - citalopram

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

medcor pharmaceuticals b.v. artemisweg 232 8239 de lelystad - citalopramhydrochloride samenstelling overeenkomend met ; citalopram - druppels voor oraal gebruik, oplossing - ethanol 76 mg/ml ; hydroxyethylcellulose ; methylparahydroxybenzoaat (e 218) ; propylparahydroxybenzoaat (e 216) ; water, gezuiverd, - citalopram

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

pharmachemie b.v. swensweg 5 2031 ga haarlem - citalopramhydrobromide 10 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; copovidon (e 1208) ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; copovidon ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; titaandioxide (e 171), - citalopram