MIGARD Film-coated tablet Ref.[8338] Active ingredients: Frovatriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg

Product name and form

MIGARD 2.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Round biconvex white film-coated tablet, debossed with “m” on one side and “2.5” on the other.

Qualitative and quantitative composition

Each film-coated tablet contains 2.5 mg of frovatriptan (as succinate monohydrate).

Excipient(s) with known effects: approximately 100 mg of lactose per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Frovatriptan

Frovatriptan is a selective agonist for 5-HT receptors. Frovatriptan is believed to act selectively on extracerebral, intracranial arteries to inhibit the excessive dilatation of these vessels in migraine.

List of Excipients

Tablet core:

Lactose, anhydrous
Microcrystalline cellulose
Silica, colloidal anhydrous
Sodium starch glycollate (Type A)
Magnesium stearate

Tablet Coat:

Opadry white:

Hypromellose (E464)
Titanium dioxide (E171)
Lactose, anhydrous
Macrogol 3000
Triacetin

Pack sizes and marketing

PVC/PE/PVDC/Aluminium blister packs with 1, 2, 3, 4, 6 and 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg

Marketing authorization dates and numbers

PL 16239/0017

Date of first authorisation: 7th October 2002
Date of latest renewal: 13th February 2008

Drugs

Drug Countries
MIGARD Estonia, Finland, Lithuania, United Kingdom

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