The Therapeutic Goods Administration is experiencing system issues linked to global Microsoft outages. Some services may be disrupted and we may take longer to respond to email and phone contact during this time.
VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN (Generic Partners Pty Ltd)
Product name
VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
175 working days (255)
Active ingredients
valganciclovir
Registration type
New generic medicine
Indication
VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN (film-coated tablets) are indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).
VALLITTE, VALGANE, VALGANCICLOVIR GXP, VALGANCICLOVIR GENPAR, VALGANCICLOVIR GPPL, CLOVIGAN is indicated for the prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk.