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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
L04AX07 MAROVAREX G Dimethyl Fumarate - 240mg Capsule, hard, gastro-resistant 60,848,734 L.L
L04AX03 METOJECT G Methotrexate disodium - 10mg/0.2ml 10mg/0.2ml Injectable solution 1,553,482 L.L
L04AX03 METOJECT G Methotrexate disodium - 15mg/0.3ml 15mg/0.3ml Injectable solution 1,968,729 L.L
L04AX03 METOJECT G Methotrexate disodium - 20mg/0.4ml 20mg/0.4ml Injectable solution 2,134,022 L.L
L04AX03 METOJECT G Methotrexate disodium - 25mg/0.5ml 25mg/0.5ml Injectable solution 2,582,865 L.L
L04AA42 MAYZENT B Siponimod - 0.25mg 0.25mg Tablet, film coated 15,102,158 L.L
L04AA42 MAYZENT B Siponimod - 0.25mg 0.25mg Tablet, film coated 124,258,444 L.L
L04AA42 MAYZENT B Siponimod - 2mg 2mg Tablet, film coated 124,258,444 L.L
L04AA06 MYFORTIC B Mycophenolic acid (sodium) - 360mg 360mg Tablet, gastroresistant 19,462,901 L.L
L04AA06 MMF G Mycophenolate mofetil - 500mg 500mg Tablet, coated 4,087,969 L.L
L03AX16 MOZOBIL B Plerixafor - 20mg/ml 20mg/ml Injectable solution 413,801,327 L.L
L01FX02 MYLOTARG BioTech Gemtuzumab Ozogamicin - 4.5mg 4.5mg Injectable powder 748,160,090 L.L
L01FG01 MVASI BioTech Bevacizumab - 400mg/16ml 400mg/16ml Injectable concentrate for solution 58,035,926 L.L
L01FG01 MVASI BioTech Bevacizumab - 100mg/4ml 100mg/4ml Injectable concentrate for solution 17,173,671 L.L
L01FD01 MABTIN 440 BioTech Trastuzumab (r-DNA origin) - 440mg 440mg Injectable powder for solution 70,042,700 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 22,183,393 L.L
L01FA01 MABIXEN 100 BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 11,091,696 L.L
L01FA01 MABTHERA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution 35,722,424 L.L
L01FA01 MABIXEN 500 BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 136,761,210 L.L
L01FA01 MABIXEN 500 BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 74,718,320 L.L
L01FA01 MABTHERA BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrated solution 80,211,932 L.L
L01EB02 MIRATA G Erlotinib (HCl) - 100mg 100mg Tablet, film coated 77,379,009 L.L
L01EB02 MIRATA G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 88,599,923 L.L
L01DB07 MITOXANTRON EBEWE G Mitoxantrone - 20mg/10ml 20mg/10ml Injectable concentrated solution 11,064,120 L.L
L01BB04 MAVENCLAD B Cladribine - 10mg 10mg Tablet 192,617,092 L.L
L01BA01 METHOTREXAT EBEWE G Methotrexate - 500mg 500mg Injectable solution 1,842,408 L.L
J07BD52 M-M-R II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE) B Rubella virus live attenuated - , Mumps virus live attenuated - , Measles virus live attenuated - Injectable solution+diluent 12,924,401 L.L
J07BD52 MEASLES, MUMPS AND RUBELLA VACCINE LIVE ATTENUATED (FREEZE-DRIED) MMR G Rubella virus live attenuated - ?1000CCID50 /0.5ml, Mumps virus live attenuated - ?5000CCID50 /0.5ml, Measles virus live attenuated - ?1000CCID50 /0.5ml Injectable freeze dried powder + diluent 739,113 L.L
J07AH08 MENACTRA MENINGOCOCCAL POLYSACCHARIDE DIPHTERIA TOXOID CONJUGATE VACCINE B Meningococcal Polysaccharides (serogroups A, C, Y and W-135) - 4mcg/0.5ml each, Diphteria Toxoid Protein - 48mcg/0.5ml Injectable solution 6,144,048 L.L
J07AH08 MENQUADFI G Meningococcal (serogroups A, C, W and Y) conjugate vaccine - Injectable solution 4,859,334 L.L
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