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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
L03AB07 CINNOVEX BioTech Interferon beta-1a - 30mcg 30mcg Injectable solution 39,804,728 L.L
L02BA03 FASLODEX B Fulvestrant - 250mg/5ml 250mg/5ml Injectable solution L.L
B05BB02 LO-SODIUM WITH POTASSIUM INJECTION G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate - 0.223g/100ml, Sodium chloride - 0.0585g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
J07AH08 MENQUADFI G Meningococcal (serogroups A, C, W and Y) conjugate vaccine - Injectable solution 4,859,334 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 135mcg/0.5ml 135mcg/0.5ml Injectable solution 15,796,329 L.L
M01AE03 KETOPROFENE MACOPHARMA G Ketoprofen - 100mg/100ml 100mg/100ml Injectable solution 329,241 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution L.L
B05BB02 ELECTROLYE 67 G Calcium gluconate - 0.10g/100ml, Potassium chloride - 0.075g/100ml, Sodium chloride - 0.30g/100ml, Dextrose, H2O - 5.0g/100ml Injectable solution 165,727 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution 18,197,019 L.L
B05BB02 DEXTROSE 5% IN LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,404 L.L
J07AL01 PNEUMOVAX 23 B Polysaccharides from each of 23 capsular types of Streptococcus pneumoniae - 25mcgx23serotypes/0.5ml Injectable solution 2,378,601 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.2% G Sodium chloride - 0.2g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 194,165 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.2% G Sodium chloride - 0.2g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
L03AX13 GLITAXON G Glatiramer acetate - 20mg/ml 20mg/ml Injectable solution 10,146,988 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 188,772 L.L
L03AX16 MOZOBIL B Plerixafor - 20mg/ml 20mg/ml Injectable solution 413,801,327 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 204,554 L.L
L03AX16 REVIXIL 20 G Plerixafor - 20mg/ml 20mg/ml Injectable solution 248,280,900 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 406,810 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
M01AE17 KETESSE B Dexketoprofen (trometamol) - 50mg/2ml 50mg/2ml Injectable solution 435,405 L.L
L01FX04 YERVOY BioTech Ipilimumab - 50mg/10ml 50mg/10ml Injectable solution L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 613,662 L.L
M01AE17 DEXIREN G Dexketoprofen - 50mg/2ml 50mg/2ml Injectable solution 467,657 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 374,633 L.L
M01AE17 NORMODEX G Dexketoprofen (trometamol) - 50mg/2ml 50mg/2ml Injectable solution 329,241 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 613,662 L.L
L01FF02 KEYTRUDA BioTech Pembrolizumab - 100mg/4ml 100mg/4ml Injectable solution L.L
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