New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - etidocaine 0.5% (and 1%) - solution for injection - 0.5%, 1.0% - active: etidocaine 0.5% (and 1%)

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - adrenaline acid tartrate 1:200000; etidocaine 0.5% - solution for injection - 1:200000/0.5% & 1% - active: adrenaline acid tartrate 1:200000 etidocaine 0.5%

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

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

janssen products, lp - rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663) - rilpivirine 25 mg - edurant, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with plasma hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. limitations of use: - more edurant treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to edurant treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14.1)] . edurant is indicated in combination with vocabria (cabotegravir) for short-term treatment of hiv-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir

Israel - English - Ministry of Health

j-c health care ltd - rilpivirine as hydrochloride - tablets - rilpivirine as hydrochloride 25 mg - rilpivirine - rilpivirine - edurant™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naïve adult patients with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - hiv infections - antivirals for systemic use - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 hiv‑1 rna copies/ml. as with other antiretroviral medicinal products, genotypic resistance testing should guide the use of edurant.,

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;   - film coated tablet - 25 mg - active: rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   excipient: croscarmellose sodium hypromellose lactose monohydrate   macrogol 3000 magnesium stearate microcrystalline cellulose polysorbate 20 povidone titanium dioxide triacetin - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-na?ve patients with viral load nmt 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind controlled phase iii trials in treatment na?ve adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment na?ve adult patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - rilpivirine hydrochloride; rilpivirine -

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - rilpivirine hydrochloride 27.50 mg eqv rilpivirine - tablet, film coated - 25 mg - rilpivirine hydrochloride 27.50 mg eqv rilpivirine 25 mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - rilpivirine -