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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
L02BG04 APO-LETROZOLE G Letrozole - 2.5mg 2.5mg Tablet 1,962,010 L.L
B01AF01 XARELTO B Rivaroxaban - 2.5mg 2.5mg Tablet, film coated 4,045,168 L.L
L02BG04 FEMAPLEX G Letrozole - 2.5mg 2.5mg Tablet, film coated 1,583,046 L.L
B01AF01 RIBAVAN G Rivaroxaban - 2.5mg 2.5mg Tablet, film coated 3,199,625 L.L
L02BG04 FEMAZOL G Letrozole - 2.5mg 2.5mg Tablet, film coated 1,433,432 L.L
L02BG04 LEFFTARA G Letrozole - 2.5mg 2.5mg Tablet, film coated 2,060,111 L.L
L02BG04 LETROZOLE ARROW G Letrozole - 2.5mg 2.5mg Tablet, film coated 2,402,790 L.L
B01AX05 ARIXTRA B Fondaparinux sodium - 2.5mg/0.5ml 2.5mg/0.5ml Injectable solution 5,341,774 L.L
R03AC02 ASTHALIN G Salbutamol (sulfate) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution 325,210 L.L
R05CB13 PULMOZYME BioTech Dornase alfa (desoxyribonuclease) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution L.L
R05CB13 PULMOZYME BioTech Dornase alfa (desoxyribonuclease) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution 54,658,804 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 2.5mg/dose 2.5mg/dose Injectable solution 39,601,065 L.L
R06AX29 LABIXTEN B Bilastine - 2.5mg/ml 2.5mg/ml Solution 463,626 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (25mg) 2.5mg/ml Injectable powder for concentrate for solution 24,934,922 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (100mg) 2.5mg/ml Injectable powder for concentrate for solution 16,887,989 L.L
J06BA02 HIZENTRA 1G BioHuman Immunoglobulin human - 1g/5ml 20% Injectable solution 9,246,433 L.L
J06BA02 HIZENTRA 2G BioHuman Immunoglobulin human - 2g/10ml 20% Injectable solution 17,658,835 L.L
J06BA02 HIZENTRA 4G BioHuman Immunoglobulin human - 4g/20ml 20% Injectable solution 35,323,423 L.L
B05CX01 DEXTROSE 20% INJECTION USP G Glucose - 20% 20% Injectable solution 316,025 L.L
B05CX01 DEXTROSE 20% INJECTION USP G Glucose - 20% 20% Injectable solution 183,869 L.L
B05AA01 ALBUTEIN BioHuman Human Albumin - 20% 20% Injectable solution 7,154,928 L.L
B05AA01 HUMAN ALBUMIN "OCTAPHARMA" 20% BioHuman Albumin human - 20% 20% Injectable solution 4,863,366 L.L
B05AA01 HUMAN ALBUMIN 20% SOLUTION BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
B05BA02 SMOFLIPID G Soya oil - 6%, Olive oil - 5%, Fish oil - 3%, Medium chain triglycerides - 6% 20% Injectable emulsion 1,424,473 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 5,675,800 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 784,890 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 374,633 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 613,662 L.L
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