Targretin Capsules Ref.[2557] Active ingredients: Bexarotene

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Eisai Ltd. European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom

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.

Active Ingredient
Bexarotene
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.

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
TARGRETIN	Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.