STRESAM Capsule Ref.[27562] Active ingredients: Etifoxine

Revision Year: 2010  Publisher: BIOCODEX, 7 avenue Gallieni, 94250 GENTILLY, FRANCE

Product name and form

STRESAM, capsule.

Pharmaceutical Form

Capsule (blue and white).

Qualitative and quantitative composition

Active ingredient: Etifoxine hydrochloride 50 mg.

For excipients: see 6.1.

Active Ingredient Description
Etifoxine

Etifoxine is a nonbenzodiazepine anxiolytic agent and acts as a GABAA receptor positive allosteric modulator and as a ligand for translocator proteins. Both mechanisms are conjectured to contribute to its anxiolytic properties. Etifoxine primarily indicated for short-term management of adjustment disorder, specifically instances of situational depression accompanied by anxiety, such as stress-induced anxiety.
List of Excipients

Lactose
Talc
Microcrystalline cellulose
Colloidal silica
Magnesium stearate

Pack sizes and marketing

Capsules contained within heat-formed blister packs consisting of aluminium foil and polyvinyl chloride – Cardboard box containing 60 capsules.

Box of 60 capsules.
A.M.M. 322 857.7 (France)

General classification for supply

List I.

Prescription duration is restricted to 12 weeks.

Marketing authorization holder

BIOCODEX, 7 avenue Gallieni, 94250 GENTILLY, FRANCE

Marketing authorization dates and numbers

MA239/00401

February 28th, 2006

Drugs

Drug Countries
STRESAM France, Malta, Tunisia, South Africa
 
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