Borg pharmaceutical industries
Suspected Adverse Drug Reaction Reporting Form ( Individual Case )
Reporting date:
A. Patient Information
Name / Initials:
Date of Birth:
Age:
Sex:
Weight:
Patient Contact details:
Country / City:
B. Suspected Drug(s) Information
Concentration / Strength:
Manufacturer:
Batch Number:
Expiry Date:
Indication for Use:
Daily Dose:
Role of Administration:
Date Started:
Date Stopped:
Duration of Use:
C. Suspected Reaction(s) Information
Description of Adverse Reaction:
Date Reaction Started:
Did the reaction stop after stopping the drug ?
Did the reaction reappear after retaking the drug ?
D. Seriousness
Seriousness to adverse drug reaction:
Other Specify:
Other Information:
Any Lab Tests/ Date:
Allergy / Pregnancy / Others:
E. Concomitant Drug(s)
| Name | Concentration | Route | Dose & Frequency | Used For | Date Started | Date Stopped | Batch Number |
|---|---|---|---|---|---|---|---|
| Omeprazole | 20 | Oral | Once | Gastritis | 2014 | 2017 | 048223 |
F. Reporter Details
Name:
Job:
Telephone/Mobile No.:
Address:
Email:
Any more comments:
This form should be delivered to Pharmacovigilance Department as soon as possible (not exceeding 48 hours)
Received by:
Receiver Job Tile:
Receiving Date:
Report No.:
QPPV Evaluation:
Address of the factory
District 17-Area 3-Industrial Zone 3-Borg El Arab New City- Alexandria - Egypt
Tel: (+203) 4622152/3/4 - Fax.: (203) 4622155
Email: ceo@borg-pharma.com
TF/IC/001 Rev. (1/1) 04/12/ 2014
TF/IC/001 Rev. (1/1) 04/12/ 2014