VALGANCICLOVIR Film-coated tablets Ref.[8518] Active ingredients: Valganciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, UK

Product name and form

Valganciclovir 450 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Oval, biconvex, pink colored film-coated tablets approx16.83 × 7.95 mm.

Qualitative and quantitative composition

Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Valganciclovir

Valganciclovir is an L-valyl ester (prodrug) of ganciclovir. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine and inhibits replication of herpes viruses in vitro and in vivo.

List of Excipients

Tablet core:

Povidone (K30)
Crospovidone (Type A)
Cellulose, microcrystalline (Vivapur Type 101)
Stearic acid 50

Tablet film-coat:

Opadry Pink 15B24005 containing:

Hypromellose (3cP, 6 cP)
Titanium dioxide (E171)
Macrogol MW 400/PEG
Iron oxide red (E172)
Polysorbate 80

Pack sizes and marketing

High density polyethylene (HDPE) bottles and child resistant polypropylene (PP) screw cap with induction heat sealing (with aluminum foil). The screw cap has a tamper evident.

Pack size: One bottle containing 60 film coated tablets.

Marketing authorization holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, UK

Marketing authorization dates and numbers

PL 17780/0688

22/10/2015

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