Targretin Capsules

Product name and form

Targretin 75 mg soft capsules.

Pharmaceutical Form

Soft capsule.

Off-white capsule, containing a liquid suspension and imprinted with Targretin.

Qualitative and quantitative composition

Each capsule contains 75 mg of bexarotene.

For a full list of excipients, see section 6.1.

List of Excipients

Capsule content:

Macrogol
Polysorbate
Povidone
Butylated hydroxyanisole

Capsule shell:

Gelatin
Sorbitol special-glycerin blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water)
Titanium dioxide (E171)
Printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)

Pack sizes and marketing

High-density polyethylene bottles with child-resistant closures containing 100 capsules.

Marketing authorization holder

Eisai Ltd.
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Marketing authorization dates and numbers

EU/1/01/178/001

Date of first authorisation: 29 March 2001

Date of latest renewal: 29 March 2006

Drugs

Drug
Countries
Austria, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, United Kingdom, United States