Is Tipranavir approved by the US FDA?

Drugs@FDA lists 3 application product lines for Tipranavir, including APTIVUS (Prescription); APTIVUS (Prescription); APTIVUS (Discontinued).

Is Tipranavir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tipranavir: Aptivus.

Are there safety signals or safety updates for Tipranavir?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2024-04-03).

Active substance

Tipranavir

US FDA 3
EMA 1
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
APTIVUS	250MG	capsule · oral	BOEHRINGER INGELHEIM	Prescription	22 Jun 2005
APTIVUS	100MG/ML	solution · oral	BOEHRINGER INGELHEIM	Prescription	23 Jun 2008
APTIVUS	100MG/ML	solution · oral	BOEHRINGER INGELHEIM	Discontinued	23 Jun 2008

EMA European Union — centrally authorised medicines

Aptivus Boehringer Ingelheim International GmbH · Authorised · authorised 25 Oct 2005 · ATC J05AE09

Therapeutic indication (EMA)

Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options. This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years. In deciding to initiate treatment with Aptivus, 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 Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.

Safety signals and safety-related labeling changes

US FDA 3 Apr 2024 APTIVUS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2020 APTIVUS — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No

All safety entries for tipranavir →

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.