MAJOVEN Prolonged-release capsule, hard Ref.[49892] Active ingredients: Venlafaxine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Product name and form

Majoven XL 37.5 mg prolonged release capsules, hard.

Venlafaxine Bristol Labs XL 37.5 mg prolonged release capsules, hard.

Pharmaceutical Form

Prolonged-release capsule, hard.

Size ‘3’ hard gelatin capsule with peach opaque cap and light grey opaque body filled with white to off white pellets.

Qualitative and quantitative composition

Each prolonged-release capsule contains 42.45 mg of venlafaxine hydrochloride, equivalent to 37.5 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

PL 17907/0565

Capsule contents:

Microcrystalline cellulose
Povidone K-90 D
Talc
Colloidal silicon dioxide
Magnesium stearate
Ethyl cellulose
Copovidone

Capsule shell:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)
Black iron oxide (E172)

Printing ink:

Shellac
Propylene glycol
Strong ammonia solution
Red iron oxide (E172)

Pack sizes and marketing

Blister packs of PVC/ACLAR film and Aluminium foil or PVC/PVdC film and Aluminium foil containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Marketing authorization dates and numbers

PL 17907/0565

22/09/2016

Drugs

Drug Countries
MAJOVEN Ireland, United Kingdom

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