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GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (Alphapharm Pty Ltd)
Product name
GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
155 (255 working days)
Active ingredients
ganciclovir
Registration type
New generic medicine
Indication
GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) (powder for injection) administered as the IV infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease.
Note: GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals.