APTIVUS Soft capsules Ref.[8809] Active ingredients: Tipranavir

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

Product name and form

Aptivus 250 mg soft capsules.

Pharmaceutical Form

Soft capsule.

Pink, oblong soft gelatin capsules imprinted with “TPV 250” in black.

Qualitative and quantitative composition

Each soft capsule contains 250 mg tipranavir.

Excipients with known effect: Each soft capsule contains: 100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg sorbitol

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tipranavir

Tipranavir is a non-peptidic inhibitor of the HIV-1 protease that inhibits viral replication by preventing the maturation of viral particles.

List of Excipients

Capsule contents:

Macrogolglycerol ricinoleate
Ethanol
Mono/diglycerides of caprylic/capric acid
Propylene glycol
Purified water
Trometamol
Propyl gallate

Capsule shell:

Gelatin
Red iron oxide (E172)
Propylene glycol
Purified water
‘Sorbitol special-glycerin blend’ (d-sorbitol, 1,4 sorbitan, mannitol and glycerin)
Titanium dioxide (E171)

Black printing ink:

Propylene glycol
Black iron oxide (E172)
Polyvinyl acetate phthalate
Macrogol
Ammonium hydroxide

Pack sizes and marketing

High density polyethylene (HDPE) bottle with two-piece child-resistant closure (outer and inner shell polypropylene, with a pulpboard/aluminium liner). Each bottle contains 120 soft capsules.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

EU/1/05/315/001

Date of first authorisation: 25 October 2005

Date of latest renewal: 19 June 2015

Drugs

Drug Countries
APTIVUS Austria, Australia, Canada, Estonia, Spain, France, Croatia, Ireland, Lithuania, Poland, United Kingdom, United States, South Africa

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