Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitis c, chronisch - antivirale middelen voor systemisch gebruik - olysio is geïndiceerd in combinatie met andere geneesmiddelen voor de behandeling van chronische hepatitis c (chc) bij volwassen patiënten. voor hepatitis-c-virus (hcv) genotype specifieke activiteit.

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, chronisch - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 en 5. voor hepatitis-c-virus (hcv) genotype-specifieke activiteit zie punt 4. 4 en 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, chronisch - antivirale middelen voor systemisch gebruik - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (zie punt 4. 2, 4. 4 en 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine - hiv-infecties - antivirale middelen voor systemisch gebruik - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

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

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - lamivudine 0-water 150 mg/stuk - filmomhulde tablet - crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; isomalt (e 953) ; macrogol 400 ; magnesiumstearaat (e 470b) ; polysorbaat 80 (e 433) ; titaandioxide (e 171), - lamivudine

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

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - lamivudine 0-water 300 mg/stuk - filmomhulde tablet - crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; isomalt (e 953) ; macrogol 400 ; magnesiumstearaat (e 470b) ; polysorbaat 80 (e 433) ; titaandioxide (e 171), - lamivudine

Europese Unie - Nederlands - EMA (European Medicines Agency)

viiv healthcare bv - lamivudine - hiv-infecties - antivirale middelen voor systemisch gebruik - epivir is geïndiceerd als onderdeel van antiretrovirale combinatietherapie voor de behandeling van volwassenen en kinderen die met menselijk immunodeficiëntie-virus (hiv) zijn geïnfecteerd..