Pharmacovigilance - Report an Adverse Event

How to report suspected adverse drug reactions to DEFRATAJ Deferasirox - what to include, channels, local authorities.

Patient safety is central to Taj Pharma. If you suspect an adverse drug reaction (ADR) related to DEFRATAJ Deferasirox, please report it.

What is an ADR? #

  • Side effects (expected or unexpected)
  • Lack of therapeutic effect
  • Drug interactions
  • Overdose events
  • Medication errors
  • Use during pregnancy / breast-feeding
  • Severe cutaneous reactions (SJS, TEN, DRESS)

How to Report to Taj Pharma #

Email

pharmacovigilance@tajpharma.com

Post

Qualified Person for Pharmacovigilance
Taj Pharmaceuticals Limited
Mumbai, Maharashtra, India

Information to Include #

  1. Reporter: name, role, contact
  2. Patient: initials, age, sex, weight (no full name)
  3. Product: DEFRATAJ strength, batch, expiry
  4. Dosing: dose, route, frequency, dates
  5. Event: description, onset, outcome, action taken
  6. Concomitant medications
  7. Relevant medical history

Local Authorities #

  • India: PvPI / CDSCO
  • Brazil: ANVISA VigiMed
  • EU: Yellow Card (where applicable)
  • USA: FDA MedWatch
  • Other: your national authority

Confidentiality #

PV personal data is processed per applicable law and global PV standards. See Privacy Policy.

Distributor PV Interface #

Distributors require a signed PV Agreement defining case-forwarding timelines and local authority reporting.

24-hour expedited reporting: serious adverse events reported within 24 hours.