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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization
 

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.
 
How to report

You can send the case reports using the following tools:
 
  1. For Healthcare Professionals and the Public
The Lebanese National Pharmacovigilance Program has adapted two user-friendly tools: one for Adverse Drug Reactions (Vigimobile e-Reporting e-Form) and another for reporting Adverse Events Following Immunization (Vigimobile e-Form). Both tools may be accessed by healthcare professionals and the general public.
 
  1. The VigiMobile e-Form and e-Reporting e-Form:
The VigiMobile e-Form and e-Reporting e-Form are the latest tools launched in January 2025 by the Lebanese National Pharmacovigilance Program. These digital platforms were introduced to enhance the reporting process, with the e-Reporting e-Form designed for Adverse Drug Reactions (ADRs) and the VigiMobile e-Form specifically for Adverse Events Following Immunization (AEFIs).

How to Download on Android Phones
 
  1. Scan the QR Code by pressing the link
  2. Click the three dots in the top-right corner
  3. Choose Install app
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app
 
How to Download on Apple IOS Phones
 
  1. Scan the QR Code by pressing the link
  2. Click on the share button
  3. Add VigiMobile to the home screen
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app

How to Download on Windows
  1. Press on the link
  2. Install from the Browser menu
  3. VigiMobile e-Form/e-Reporting e-Form is now installed 
 
Scan QR Codes to Report:
  1. ADRs Following Medication Use
  1. AEFIs Following Vaccine Use
Or use the following link: LNPVP: e-Reporting eForm Or use the following link: LNPVP: VigiMobile eForm
 
  1. Direct Contact with the Lebanese National Pharmacovigilance Program:
You may contact the Lebanese National Pharmacovigilance Program through:
  • Email Address:
  • Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254   
 
  1.  For Market Authorization Holders:
Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines

(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.
 
As for what to report or report type, you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-
 
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ATC Name B/G Ingredients Dosage Form Price
A11DB 3V G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 198,889 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 156,288 L.L
C07AB07 BISCORDEX G Bisoprolol fumarate - 5mg 5mg Tablet 406,992 L.L
C09DA03 VIOSTAN PLUS 320/12.5 G Valsartan - 320mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,411,419 L.L
C10BA02 INEGY G Simvastatin - 20mg, Ezetimibe - 10mg Tablet 4,452,598 L.L
D11AX18 LABDIC RELIEF G Diclofenac sodium - 1%w/w, Methyl salicylate - 8%w/w, Menthol - 2%w/w Gel 263,393 L.L
H01BA02 NICTUR G Desmopressin acetate - 360mcg/ml 360mcg/ml Solution 5,270,550 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 5,793,881 L.L
J01XX08 LINEZOLID ARROW G Linezolide - 600mg/300ml 2mg/ml Injectable solution 13,282,147 L.L
L01BC01 ALEXAN G Cytarabine - 100mg/5ml 100mg/5ml Injectable solution 388,370 L.L
N05AH03 ZOLAPINE G Olanzapine - 10mg 10mg Tablet, orodispersible 2,106,249 L.L
R03DA05 AMINOPHYLLINE CHILDREN G Aminophylline - 100mg 100mg Suppository 203,496 L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 500mg 500mg Tablet, film coated 193,513 L.L
A11DB TRILAGAVIT G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 579,196 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 165,482 L.L
C07AB07 BISOCOR 5 G Bisoprolol fumarate - 5mg 5mg Tablet, film coated 345,560 L.L
C10BA02 INEGY G Simvastatin - 40mg, Ezetimibe - 10mg Tablet 4,484,594 L.L
D11AX18 DILO G Diclofenac sodium - 8% 8% Spray 502,981 L.L
J01DD04 MEDAXONUM G Ceftriaxone (disodium) - 1g 1g Injectable powder for solution+diluent 438,093 L.L
J01XX08 ZERSA G Linezolide - 600mg/300ml 600mg/300ml Injectable solution 3,303,165 L.L
L01BC01 ALEXAN G Cytarabine - 1,000mg/20ml 1,000mg/20ml Injectable solution 2,848,946 L.L
N02BE51 ALGIN ADULTS G Paracetamol - 400mg, Caffeine - 50mg Suppository 195,817 L.L
N05AH03 ZYRWAN OD G Olanzapine - 10mg 10mg Tablet, orodispersible 2,564,819 L.L
N06DA02 ALZEPIL G Donepezil HCl - 5mg 5mg Tablet 1,406,555 L.L
R03DA11 ANSIMAR G Doxofylline - 20mg/ml 20mg/ml Syrup 550,975 L.L
S01EB09 MIOVISIN G Acetylcholine chloride - 20mg/2ml 20mg/2ml Injectable powder for solution+solvent 6,449,100 L.L
A02BX02 SUCRATE GEL G Sucralfate - 1g 1g Gel 636,981 L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 500mg 500mg Tablet, film coated 560,382 L.L
A11DB VITANOR G Vitamin B1 - 250mg, Vitamin B6 - 250mg, Vitamin B12 - 500mcg Tablet, film coated 946,065 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 176,974 L.L
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