EMA — authorised 20 October 2000
- Status: approved
🇪🇺 Agenerase in European Union
EMA authorised Agenerase on 20 October 2000
Marketing authorisations
EMA — authorised 20 October 2000
- Application: EMEA/H/C/000264
- Marketing authorisation holder: Glaxo Group Ltd.
- Local brand name: Agenerase
- Indication: 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)
- Status: withdrawn
Agenerase in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Agenerase approved in European Union?
Yes. EMA authorised it on 20 October 2000; EMA authorised it on 20 October 2000.
Who is the marketing authorisation holder for Agenerase in European Union?
GSK is the originator. The local marketing authorisation holder may differ — check the official source linked above.