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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 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution 15,147,973 L.L
L03AB07 BLASTOFERON BioTech Interferon beta-1a - 22mcg 22mcg Injectable solution 40,725,735 L.L
L03AB07 AVONEX BioTech Interferon beta-1a - 30mcg/0.5ml 30mcg/0.5ml Injectable solution 70,488,764 L.L
L03AB07 CINNOVEX BioTech Interferon beta-1a - 30mcg 30mcg Injectable solution 39,804,728 L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 135mcg/0.5ml 135mcg/0.5ml Injectable solution 15,796,329 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution 18,197,019 L.L
L03AX03 SII-ONCO-BCG G Bacillus Calmette- Guerin Strain - 40mg/ml (1-8x10?CFU) 40mg/ml Injectable dry powder 6,987,981 L.L
L03AX03 BCG-MEDAC G BCG seed RIVM derived from seed 1173-P2 - 2x10? to 3x10? viable units Injectable powder for suspension+diluent 13,873,850 L.L
L03AX13 GLITAXON G Glatiramer acetate - 20mg/ml 20mg/ml Injectable solution 10,146,988 L.L
L03AX16 MOZOBIL B Plerixafor - 20mg/ml 20mg/ml Injectable solution 413,801,327 L.L
L03AX16 REVIXIL 20 G Plerixafor - 20mg/ml 20mg/ml Injectable solution 248,280,900 L.L
L04AA04 THYMOGLOBULINE 5mg/ml BioTech Rabbit anti-human thymocyte immunoglobulin - 25mg/5ml 25mg/5ml Injectable powder for solution 21,092,764 L.L
L04AA06 MYFORTIC B Mycophenolic acid (sodium) - 360mg 360mg Tablet, gastroresistant 19,462,901 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 250mg 250mg Capsule 6,083,575 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 500mg 500mg Tablet 6,083,575 L.L
L04AA06 IMUNOCELL G Mycophenolate mofetil - 500mg 500mg Tablet, film coated 3,791,428 L.L
L04AA06 MMF G Mycophenolate mofetil - 500mg 500mg Tablet, coated 4,087,969 L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet 12,907,489 L.L
L04AA10 SIROMUNE G Sirolimus - 1mg 1mg Tablet, film coated 18,729,193 L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
L04AA13 ARAVA B Leflunomide - 10mg 10mg Tablet, film coated 2,230,779 L.L
L04AA13 AROTAN G Leflunomide - 10mg 10mg Tablet, film coated 1,527,949 L.L
L04AA13 ARAVA B Leflunomide - 20mg 20mg Tablet, film coated 3,346,168 L.L
L04AA13 AROTAN G Leflunomide - 20mg 20mg Tablet, film coated 2,014,420 L.L
L04AA18 CERTICAN B Everolimus - 0.75mg 0.75mg Tablet L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet 29,146,785 L.L
L04AA18 CERTICAN B Everolimus - 0.75mg 0.75mg Tablet 39,404,119 L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet L.L
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