Leaflet VALGANCICLOVIR AUROBINDO 450mg film-coated tablets


Indicated for: cytomegalovirus infection

Substance: valganciclovir (antiviral)

ATC: J05AB14 (Antiinfectives for systemic use | Direct acting antivirals | Nucleosides and nucleotides excl. reverse transcriptase inhibitors)

Valganciclovir is an antiviral medication used for the treatment and prevention of cytomegalovirus (CMV) infections in immunocompromised patients, such as those who have undergone organ transplantation or are infected with HIV. It is a prodrug of ganciclovir, which is active against CMV by inhibiting viral DNA synthesis, thereby preventing viral replication.

The medication is administered orally, usually once or twice daily, depending on the therapeutic indication and the patient's condition. The dosage is adjusted based on the patient's renal function to reduce the risk of toxicity.

Common side effects include nausea, diarrhea, anemia, neutropenia, and fatigue. In rare cases, severe adverse reactions such as renal failure, severe myelosuppression, or allergic reactions may occur.

Valganciclovir is an essential medication for managing CMV infections in immunocompromised patients, helping to prevent severe complications associated with this viral infection.

General data about VALGANCICLOVIR AUROBINDO 450mg

  • Substance: valganciclovir
  • Date of last drug list: 01-02-2023
  • Commercial code: W66450001
  • Concentration: 450mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 60
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: APL SWIFT SERVICES (MALTA) LIMITED - MALTA
  • Holder: AUROBINDO PHARMA ROMÂNIA SRL - ROMANIA
  • Number: 12475/2019/03
  • Shelf life: 3 years

Pharmaceutical forms available for valganciclovir

Concentrations available for valganciclovir

  • 450mg
  • 50mg/ml