PROVIGIL Tablet Ref.[6996] Active ingredients: Modafinil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Product name and form

PROVIGIL 100 mg tablets.

Pharmaceutical Form

Tablet.

The tablets are white to off-white, 13 × 6 mm, capsule-shaped and debossed with ‘100’ on one side.

Qualitative and quantitative composition

Each tablet contains 100 mg of modafinil.

Excipient(s) with known effect: Each tablet contains 68mg of anhydrous lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Modafinil

Modafinil promotes wakefulness in a variety of species, including man. The precise mechanism(s) through which modafinil promotes wakefulness is unknown.

List of Excipients

Lactose monohydrate
Pregelatinised starch (maize)
Microcrystalline cellulose
Croscarmellose sodium
Povidone K29/32
Magnesium stearate

Pack sizes and marketing

Opaque PVC/PVDC/aluminium blisters.

Packs of 10, 20, 30, 50, 60, 90, 100 or 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Marketing authorization dates and numbers

PL 14776/0098

Date of first authorisation: 14 October 1997
Date of latest renewal: 24 June 2017

Drugs

Drug Countries
PROVIGIL Estonia, Ireland, Israel, Malta, United Kingdom, United States, South Africa

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