US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| AGENERASE | 50MG; 150MG | capsule · oral | GLAXOSMITHKLINE | Discontinued | 15 Apr 1999 |
| AGENERASE | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · oral | GLAXOSMITHKLINE | Discontinued | 15 Apr 1999 |
EMA European Union — centrally authorised medicines
Agenerase Glaxo Group Ltd. · Withdrawn · authorised 20 Oct 2000 · ATC J05AE05
Therapeutic indication (EMA)
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.