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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
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
A11CC05 BIO-D3 25000IU G Vitamin D3 - 25000IU 25000IU Capsule 2,147,588 L.L
C10AX06 VASCEPA B Eicosapentaenoic acid (Ethyl ester) - 1g 1g Capsule 21,464,912 L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 1,130,108 L.L
L04AD02 TACROGRAF 5 G Tacrolimus - 5mg 5mg Capsule 67,507,154 L.L
N02BE51 HUMEXLIB PARACETAMOL CHLORPHENAMINE B Paracetamol - 500mg, Chlorphenamine maleate - 4mg Capsule 598,010 L.L
N06DA03 RIVASTIGMINE ARROW G Rivastigmine - 4.5mg 4.5mg Capsule 842,589 L.L
A02BC05 ESOCAP-UBSA G Esomeprazole - 40mg 40mg Capsule 646,324 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 2,147,588 L.L
J02AC01 DIFLUCAN B Fluconazole - 50mg 50mg Capsule 622,199 L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule 13,942,481 L.L
M03BB53 PARAXONE-JPI G Paracetamol - 300mg, Chlorzoxazone - 250mg Capsule 334,617 L.L
N06DA03 RIVASTIGMINE ARROW G Rivastigmine - 4.5mg 4.5mg Capsule 842,589 L.L
J02AC01 FLUNAZOL G Fluconazole - 50mg 50mg Capsule 534,465 L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule 13,942,481 L.L
M03BB53 RELAXON G Paracetamol - 300mg, Chlorzoxazone - 250mg Capsule 296,989 L.L
N06DA52 EXENTAZIL G Donepezil - 10mg, Memantine - 28mg Capsule 4,363,009 L.L
L04AD02 TACROGRAF 0.5 G Tacrolimus - 0.5mg 0.5mg Capsule 7,004,024 L.L
N06DA52 MEXAZIL XR 28/10 G Memantine HCl - 28mg, Donepezil HCl - 10mg Capsule 4,333,444 L.L
J02AC01 FUNZOL 50 G Fluconazole - 50mg 50mg Capsule 373,588 L.L
N06DA52 EXENTAZIL G Donepezil - 10mg, Memantine - 14mg Capsule 3,117,715 L.L
N06DA52 MEXAZIL XR 14/10 G Memantine HCl - 14mg, Donepezil HCl - 10mg Capsule 3,432,174 L.L
J02AC01 STABILANOL G Fluconazole - 100mg 100mg Capsule 1,377,771 L.L
J02AC01 DIFLUCAN B Fluconazole - 150mg 150mg Capsule 286,238 L.L
J02AC01 CANDIZOL G Fluconazole - 150mg 150mg Capsule 385,235 L.L
L04AX02 THALIDOMIDE BMS B Thalidomide - 50mg 50mg Capsule 27,387,764 L.L
J02AC01 FLOCAZOLE G Fluconazole - 150mg 150mg Capsule 172,012 L.L
L04AX02 THALIDOMIDE CELGENE B Thalidomide - 50mg 50mg Capsule 27,387,764 L.L
J02AC01 FLUCOKEY G Fluconazole - 150mg 150mg Capsule 81,974 L.L
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