VIRGAN Eye gel Ref.[8187] Active ingredients: Ganciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: LABORATOIRES THEA, 12 RUE LOUIS-BLERIOT, Z.I. DU BREZET, 63017 CLERMONT, FERRAND CEDEX 2, FRANCE

Product name and form

VIRGAN 0.15% w/w eye gel.

Pharmaceutical Form

Eye gel. Colourless opalescent gel.

Qualitative and quantitative composition

1 g gel contains 1.5 mg ganciclovir (0.15% w/w).

Excipient with known effect: benzalkonium chloride (75 ยตg/g).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ganciclovir

Ganciclovir, 9-(1,3-dihydroxy-2-propoxymethyl)guanine or DHPG, is a broadspectrum virustatic agent which inhibits the replication of viruses, including viruses of the herpes group, both in vivo and in vitro: herpes simplex types 1 and 2 (HSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes zoster (HZV).

List of Excipients

Benzalkonium chloride
Carbomer 974P
Sorbitol
Sodium hydroxide
Purified water

Pack sizes and marketing

5g tube (polyethylene-aluminium) with dropper nozzle (polyethylene) and screw cap (polyethylene).

Marketing authorization holder

LABORATOIRES THEA, 12 RUE LOUIS-BLERIOT, Z.I. DU BREZET, 63017 CLERMONT, FERRAND CEDEX 2, FRANCE

Marketing authorization dates and numbers

PL 20162/0006

21/07/2000 / 20/07/2005

Drugs

Drug Countries
VIRGAN Spain, France, Hong Kong, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom

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