VENLABLUE XL Prolonged-release capsule, hard Ref.[49959] Active ingredients: Venlafaxine

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Product name and form

Venlablue XL 75 mg, prolonged-release capsules, hard.

Pharmaceutical Form
Prolonged-release capsule, hard. Peach opaque/peach opaque, size ‘1’ hard gelatin capsules having thick and thin radial circular band on the body in red ink and thick and thin radial circular band on the cap in red ink. The capsule is filled with 6 white to off-white, round, biconvex, film coated mini tablets of 12.5 mg each.

Qualitative and quantitative composition

Each capsule contains: Venlafaxine hydrochloride, corresponding to 75 mg Venlafaxine.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Venlafaxine	Venlafaxine has an antidepressant effect. The mechanism of its action in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system.

List of Excipients
Tablet core: Microcrystalline cellulose Povidone Talc Silica, colloidal anhydrous Magnesium stearate Tablet film coat: Ethyl cellulose Copovidone Capsule: Black iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Gelatin Printing inks: Shellac Red iron oxide

Pack sizes and marketing

Blister packs of opaque, white PVC/Aclar film and aluminium foil; 10, 14, 28, 30, 50& 100 capsules

Blister packs of opaque, white PVC/PVdC film and aluminium foil; 10, 14, 28, 30, 50& 100 capsules

Not all pack sizes may be marketed.

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Marketing authorization dates and numbers

PA1436/006/001

Date of first authorisation: 9^th April 2010
Date of last renewal: 18^th March 2015

Drugs

Drug	Countries
VENLABLUE	Ireland, United Kingdom

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