Name:

Please provide your name since you are reporting the event.

Name or Initials:

Enter name or initials accurately. This is essential to facilitate identification and to locate the patient if needed.

Age or Date of Birth:

Provide the most precise information available. Enter the birth date, if known or age in years.

Gender:

Select appropriate option of gender.

• You can provide information on suspectBiocon product.
• Please provide accurate names of the suspected medicinal product (brand name and generic name), the dosage form it is available for use (tablet/injection/liquid/syrup/solution etc.), and strength in mg or mg/ml or as appropriate (example 500mg or 25 mg/ml).
• Provide accurate lot no / batch no
• If accurate dates of use are not known please provide the approximate duration of use in hours/days/weeks/months or years.

Enter the date and time of the onset of the adverse event/side effect, date and time of the end of adverse event (if the adverse event has stopped). If accurate dates are not known, please provide the approximate duration of the event.

• If you are lodging a product complaint explain here in detail the same.
• Indicate clearly the adverse event name or diagnosis of the event (if you are health care professional).
• Describe the event with detailed description of what happened and a summary of all relevant clinical information

• Check the appropriate block to indicate the outcome of the event - whether recovered completely, not recovered, recovered with sequelae or fatal and provide dates where ever they are required to be filled in the form.
• If the information for all of the above is not available, check in the block for unknown.
• Check in the appropriate block to indicate whether the event appeared again after stopping the therapy and whether the events reappear again after rechallenge of the drug.
• If it reappeared, how long the treatment lasted until reappearance.