VALACICLOVIR Film-coated tablet Ref.[7371] Active ingredients: Valaciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Valaciclovir 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Blue, film-coated, capsule shaped tablets with a partial score bar on both sides containing ‘F’ on one side and ‘9’ and ‘3’ on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains valaciclovir hydrochloride (hydrated) equivalent to 500 mg valaciclovir.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Valaciclovir

Valaciclovir, an antiviral, is the L-valine ester of aciclovir. Valaciclovir is rapidly and almost completely converted in man to aciclovir and valine. Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and human herpes virus 6 (HHV-6).

List of Excipients

Core:

Cellulose, microcrystalline
Crospovidone (Type A)
Povidone K90
Magnesium stearate

Film-coating:

Hypromellose
Indigo carmine aluminium lake (E132)
Titanium dioxide (E171)
Macrogol 400
Polysorbate

Pack sizes and marketing

Clear PVC/PVdC Aluminium foil blister or HDPE bottle with PP closure.

Pack sizes:

Blister: 7, 10, 21, 30, 42, 50, 90 & 112 tablets.

HDPE bottle: 30 & 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0271

04/11/2011

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