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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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L01EH01 TYKERB B Lapatinib ditosylate - 250mg 250mg Tablet, film coated 101,971,611 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 - 2mg 2mg Tablet, film coated 1,138,235 L.L
A07EC02 PENTASA B Mesalazine - 1g 1g Enema 2,791,161 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 7.5mg/dose 7.5mg/dose Injectable solution 39,601,065 L.L
L01EJ01 JAKAVI B Ruxolitinib - 5mg 5mg Tablet 165,514,059 L.L
N03AX22 FYCOMPA B Perampanel - 4mg 4mg Tablet, film coated 8,751,127 L.L
R03AC02 VENTOLIN B Salbutamol (sulfate) - 5mg/ml 5mg/ml Solution 403,153 L.L
A07EC02 SALOFALK B Mesalazine - 1.5g 1.5g Granules, gastro-resistant, prolonged release 6,150,767 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 10mg/dose 10mg/dose Injectable solution 39,601,065 L.L
M01AE11 SURGAM B Tiaprofenic acid - 300mg 300mg Tablet 849,308 L.L
N02BA01 ASPIRINE B Acetylsalicylic acid - 300mg 0.3g Tablet 80,631 L.L
N03AX22 FYCOMPA B Perampanel - 6mg 6mg Tablet, film coated 8,751,127 L.L
A07EC02 SALOFALK B Mesalazine - 3g 3g Granules, gastro-resistant, prolonged release 11,256,652 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 12.5mg/dose 12.5mg/dose Injectable solution 39,601,065 L.L
J07BD52 PRIORIX B Rubella virus live attenuated - ?10³ CCID50, Mumps virus live attenuated - ?103.7 CCID50, Measles virus live attenuated - ?10³ CCID50 Injectable lyophilised powder for solution+diluent 1,142,266 L.L
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A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 8,454,523 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 15mg/dose 15mg/dose Injectable solution 39,601,065 L.L
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L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 12,310,378 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 500mg 500mg Capsule 659,123 L.L
    ...
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