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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
M01AB05 EMIFENAC 50 G Diclofenac sodium - 50mg 50mg Tablet, dispersible 387,027 L.L
L04AX04 ERVALI G Lenalidomide - 15mg 15mg Capsule, hard 74,977,720 L.L
L04AX04 ERVALI G Lenalidomide - 25mg 25mg Capsule, hard 81,147,769 L.L
L04AX04 ERVALI G Lenalidomide - 5mg 5mg Capsule, hard 37,370,561 L.L
L04AX04 ERVALI G Lenalidomide - 10mg 10mg Capsule, hard 71,493,520 L.L
L04AX03 EBETREXAT G Methotrexate - 5mg 5mg Tablet, scored 2,488,796 L.L
L04AX03 EBETREXAT G Methotrexate - 15mg/1.5ml 15mg/1.5ml Injectable solution 2,135,366 L.L
L04AB01 ETANERREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 59,029,176 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 40,824,526 L.L
L04AB01 ENBREL BioTech Etanercept - 25mg 25mg Injectable solution 28,768,353 L.L
L04AB01 ERELZI BioTech Etanercept - 25mg 25mg Injectable solution 25,751,867 L.L
L04AB01 ETANERREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 5,085,100 L.L
L04AB01 ETANERREL BioTech Etanercept - 50mg/ml 50mg/ml Injectable solution 9,756,719 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 300mg 300mg Injectable powder for concentrate for solution 152,492,033 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 92,478,560 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 92,478,560 L.L
L02BG06 EXEMESTANE G Exemestane - 25mg 25mg Tablet, film coated 1,222,897 L.L
L02BG06 EXEMESTANE ARROW G Exemestane - 25mg 25mg Tablet, film coated 3,386,483 L.L
L02BG06 EXEMESTANE BGR G Exemestane - 25mg 25mg Tablet, coated 4,479,027 L.L
L02BG06 EXEMESTANE GENEPHARM G Exemestane - 25mg 25mg Tablet, film coated 1,286,662 L.L
L02BG06 EXEMESTANE PHARMINICIO G Exemestane - 25mg 25mg Tablet, film coated 1,158,392 L.L
L02BB05 ERLEADA B Apalutamide - 60mg 60mg Tablet, film coated 264,151,186 L.L
L02BB04 ENZASTIK 40 G Enzalutamide - 40mg 40mg Capsule 82,838,963 L.L
L02BB04 ENZASTIK 40 G Enzalutamide - 40mg 40mg Capsule L.L
L01XX02 ERWINASE BioTech Erwinia L-asparaginase - 10,000IU 10,000IU Injectable lyophilised powder for solution 444,434,845 L.L
L01XJ01 ERIVEDGE B Vismodegib - 150mg 150mg Capsule 465,368,012 L.L
L01XA03 ELOXATIN B Oxaliplatin - 50mg/10ml 50mg/10ml Injectable concentrated solution 4,930,558 L.L
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