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TARGRETIN Soft capsule (2019)

Active ingredients: Bexarotene

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.

Excipient(s) with known effect: sorbitol

For the full list of excipients, see section 6.1.

Chemical substance
Description
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
Authorization dates

Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, e-mail: medinfo_de@eisai.net

Date of first authorisation: 29 March 2001

Date of latest renewal: 24 April 2006

Marketing authorization number:

EU/1/01/178/001