VECTAVIR Cream Ref.[50416] Active ingredients: Penciclovir

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland

Product name and form

Vectavir Cold Sore Cream.

Pharmaceutical Form

Cream.

Smooth white cream of homogeneous appearance.

Qualitative and quantitative composition

Each gram of the cream contains 10 mg penciclovir.

Excipients with known effect: cetostearyl alcohol, propyleneglycol.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Penciclovir

Penciclovir has demonstrated in vivo and in vitro activity against herpes simplex viruses (types 1 and 2) and varicella zoster virus. Penciclovir triphosphate persists in infected cells for more than 12 hours where it inhibits replication of viral DNA and has a half-life of 9, 10 and 20 hours in cells infected with varicella zoster virus, herpes simplex virus type 1 and herpes simplex virus type 2 respectively.

List of Excipients

White soft paraffin
Liquid paraffin
Cetostearyl alcohol (see section 4.4 ‘Special warnings and precautions for use’)
Propylene glycol (see section 4.4 ‘Special warnings and precautions for use’)
Cetomacrogol 1000
Purified water

Pack sizes and marketing

2g and 5g aluminium tube. May be supplied with 20 single-use Low Density Polyethylene(LDPE) applicators.

2g plastic airless pump dispenser.

Not all pack sizes may be marketed.

Marketing authorization holder

Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland

Marketing authorization dates and numbers

PA1186/020/001

Date of first authorisation: 28 February 2001
Date of last renewal: 27 February 2006

Drugs

Drug Countries
VECTAVIR Finland, Ireland, New Zealand, Turkey

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