FAMVIR Film-coated tablets Ref.[7810] Active ingredients: Famciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Product name and form

Famvir 125 mg film-coated tablets.

Famciclovir 125 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round film-coated tablet, biconvex, bevelled edges, debossed with “FV” on one side and “125” on the reverse side.

Qualitative and quantitative composition

Each film-coated tablet contains 125 mg of famciclovir.

Excipient with known effects: Each film-coated tablet contains 26.85 mg of lactose, anhydrous.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Famciclovir

Famciclovir is the oral prodrug of penciclovir. Famciclovir is rapidly converted in vivo into penciclovir, which has in vitro activity against herpes simplex viruses (HSV types 1 and 2), varicella zoster virus (VZV), Epstein-Barr virus and cytomegalovirus.

List of Excipients

Tablet core:

Lactose, anhydrous
Sodium starch glycolate (Type A)
Hydroxypropyl cellulose
Magnesium stearate

Tablet coat:

Hypromellose
Titanium dioxide (E171)
Macrogol 4000
Macrogol 6000

Pack sizes and marketing

Famvir is supplied in PVC/PCTFE/Aluminium blister packs containing 10 tablets.

Marketing authorization holder

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 00101/0625

21 April 1995/08 July 2011

Drugs

Drug Countries
FAMVIR Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Ireland, Italy, Japan, Malta, New Zealand, United Kingdom, South Africa

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