United States - English - NLM (National Library of Medicine)

pharmasource meds, llc - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - adult patients: isentress ® and isentress ® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the met

United States - English - NLM (National Library of Medicine)

proficient rx lp - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital d

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital d

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - raltegravir as potassium - film coated tablets - raltegravir as potassium 400 mg - raltegravir - isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients.this indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients and one double-blind, active-controlled trial in treatment-naive patients.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - raltegravir potassium eqv raltegravir free phenol - tablet, film coated - raltegravir potassium eqv raltegravir free phenol 600mg

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - raltegravir potassium 651.6mg equivalent to raltegravir 600 mg;   - film coated tablet - 600 mg - active: raltegravir potassium 651.6mg equivalent to raltegravir 600 mg   excipient: carnauba wax croscarmellose sodium hypromellose magnesium stearate microcrystalline cellulose opadry yellow 39k170005 - indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection.

Namibia - English - Namibia Medicines Regulatory Council

msd pty ltd - raltegravir potassium - tablets - each film-coated tablet contains 434,4 mg ; raltegravir potassium (as salt) equivalent to; raltegravir (free phenol) 400,0 mg

Namibia - English - Namibia Medicines Regulatory Council

msd (pty) ltd - raltegravir - tablet - each chewable tablet contains; raltegravir potassium equiv. to raltegravir 25,0 mg

Namibia - English - Namibia Medicines Regulatory Council

msd (pty) ltd - raltegravir - tablet - each chewable tablet contains; raltegravir potassium equiv. to raltegravir 100,0 mg

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - raltegravir - hiv infections - antivirals for systemic use - isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection.