Micro Labs Limited - ADR Reporting Form

FOR HEALTH CARE PROFESSIONALS

Suspected ADRs reporting form (for HCPs)

Points to Consider:

Provide as many details as possible. This will help us to understand the case better.
The patient/reporter's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the patient/reporter's identity in response to a request from the public.
The data may be shared with the competent authorities as required to comply with the regulatory requirements.
Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.

A. Patient Information

Patient Initials

Date of Birth

Age

Sex

Male Female

Weight in Kg

B. Suspected Adverse Reaction

Date of reaction started

Date of Recovery

Describe reaction or problem:

C. Suspected Medication(s)

#	Name (brand and/or generic name)	Manufacturer	Dose used	Route used	Frequency
1.*

#	Batch No./Lot No.	Exp. Date	Therapy dates		Reason for Use
#	Batch No./Lot No.	Exp. Date	Started	Stopped	Reason for Use
1.*

Reaction abated after drug stopped or dose reduced:

Yes No Unknown NA Reduced dose

Concomitant medical products and therapy dates (including self-medication and herbal remedies):

Relevant tests / laboratory data with dates:

Other relevant history (e.g., allergies, pregnancy, smoking, alcohol use, etc.):

Seriousness of the reaction:

Death Life-threatening Hospitalization Disability Congenital anomaly Required intervention Other (specify)

Outcomes:

Fatal Recovering Unknown Continuing Recovered Other

D. Reporter Information

Name and Professional Address

PIN Code

Cell No. / Tel. No. with STD Code

Occupation

Causality Assessment

Date of this report

Other Ways to Report

If you wish to report by any other means like Telephone, Email, Postal Mail, etc., you may select one from the following options:

1. By Phone: Medical Information Contact Center and ADR reporting - Dial 080-22343023.
2. By Email: Simply send an email to drugsafety@microlabs.in.
3. By Post/Fax: Download the adverse event reporting form, fill it out, and send it to us.

Download Form

Please fill and send it to us in any of the following ways:

Send the completed form to:

MICRO LABS LIMITED
Pharmacovigilance Cell
31, Race Course Road, Bangalore-560001
Phone No: 080-22343023
E-mail: drugsafety@microlabs.in
Website: www.microlabsltd.com

Scan and E-mail the completed form to:

drugsafety@microlabs.in