EFEXOR XL Prolonged-release capsule, hard Ref.[50857] Active ingredients: Venlafaxine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Product name and form

Efexor XL 150 mg prolonged-release capsules, hard.

Pharmaceutical Form

Prolonged-release capsule, hard.

Opaque dark orange capsules printed in white with ‘W’ and ‘150’, hard gelatin capsule, size 0 (23.5 mm x 7.65 mm).

Qualitative and quantitative composition

Efexor XL 150 mg: Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine free base.

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

Capsule contents:

Microcrystalline cellulose
Ethylcellulose
Hypromellose
Talc

Capsule shell:

Gelatin
Red and yellow iron oxides (E172)
Titanium dioxide (E171)

Capsule printing ink:

Shellac,
Propylene glycol,
Sodium hydroxide,
Povidone,
Titanium dioxide (E171)

Pack sizes and marketing

Clear or opaque PVC/Aluminium foil blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100.

Hospital packs of 500 (10x50), 1000 (10x100).

PVC/Aluminium foil blister unit dose packs of 14, 28, 84, 100.

High-density polyethylene (HDPE) bottles of 14, 20, 50, 100; Hospital packs of 500, 1000.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Marketing authorization dates and numbers

PA23355/002/003

Date of first authorisation: 26th July 1999
Date of last renewal: 20th October 2014

Drugs

Drug Countries
EFEXOR Australia, Brazil, Cyprus, Ecuador, Estonia, Finland, Hong Kong, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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