Active ingredients: Bexarotene
Targretin 75 mg soft capsules.
Soft capsule.
Off-white capsule, containing a liquid suspension and imprinted with Targretin.
Each capsule contains 75 mg of bexarotene.
For a full list of excipients, see section 6.1.
Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: α, β, and γ. Once activated, these receptors function as transcription factors that regulate processes such as cellular differentiation and proliferation, apoptosis, and insulin sensitisation. The exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
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%)
High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Eisai Ltd.
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom
Date of first authorisation: 29 March 2001
Date of latest renewal: 29 March 2006
EU/1/01/178/001