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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
L01EG02 AFINITOR B Everolimus - 10mg 10mg Tablet 205,782,764 L.L
M01AE03 BI-PROFENID LP B Ketoprofen - 100mg 100mg Tablet, prolonged release 392,402 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 100mg 100mg Tablet, modified release 236,516 L.L
N03AX22 FYCOMPA B Perampanel - 2mg 2mg Tablet, film coated 1,138,235 L.L
R03AC02 VENTOLIN EVOHALER B Salbutamol (sulfate) - 100mcg/dose 100mcg/dose Inhalation aerosol metered dose 260,705 L.L
L04AX06 IMNOVID B Pomalidomide - 4mg 4mg Capsule, hard L.L
A07EC02 PENTASA B Mesalazine - 1g 1g Tablet, controlled release 4,945,340 L.L
C03CA01 LASIX B Furosemide - 500mg 500mg Tablet 1,454,038 L.L
D07XC04 TRAVOCORT B Diflucortolone valerate - 0.1%, Isoconazole nitrate - 1% Cream 435,405 L.L
L04AA06 MYFORTIC B Mycophenolic acid (sodium) - 360mg 360mg Tablet, gastroresistant 19,462,901 L.L
M01AE03 PROFENID B Ketoprofen - 100mg 100mg Suppository 321,178 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 150mg 150mg Tablet, modified release 356,118 L.L
N03AX22 FYCOMPA B Perampanel - 4mg 4mg Tablet, film coated 8,751,127 L.L
A10BK03 JARDIANCE B Empagliflozin - 10mg 10mg Tablet, film coated 3,081,923 L.L
C03CA02 BURINEX B Bumetanide - 1mg 1mg Tablet 335,961 L.L
J07BC02 HAVRIX '1440' B Hepatitis A, inactivated, whole virus - 1,440 ELISA units/ml 1,440 ELISA units/ml Injectable suspension 2,215,996 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 250mg 250mg Capsule 6,083,575 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 200mg 200mg Tablet, modified release 474,376 L.L
N03AX22 FYCOMPA B Perampanel - 6mg 6mg Tablet, film coated 8,751,127 L.L
A07EC02 SALOFALK B Mesalazine - 1000mg 1000mg Granules, gastro-resistant, prolonged release 3,874,298 L.L
C03CA02 BURINEX B Bumetanide - 5mg 5mg Tablet 1,054,916 L.L
G04BE08 CIALIS B Tadalafil - 5mg 5mg Tablet, film coated 6,512,261 L.L
J01MA06 NOROXIN B Norfloxacin - 400mg 400mg Tablet, film-scored 574,653 L.L
J07BC02 HAVRIX JUNIOR 720 B Hepatitis A, inactivated, whole virus - 720 ELISA units/0.5ml 720 ELISA units/0.5ml Injectable suspension 1,491,665 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 500mg 500mg Tablet 6,083,575 L.L
N02AX02 TRAMAL RAPIDE B Tramadol HCl - 50mg 50mg Tablet 388,370 L.L
N03AX22 FYCOMPA B Perampanel - 8mg 8mg Tablet, film coated 10,180,812 L.L
R03AC02 VENTOLIN B Salbutamol (sulfate) - 5mg/ml 5mg/ml Solution 403,153 L.L
A07EC02 PENTASA XTEND B Mesalazine - 2g 2g Granules for suspension 8,550,789 L.L
C03DA01 ALDACTONE B Spironolactone - 100mg 100mg Tablet 458,250 L.L
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