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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
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
N02CD02 EMGALITY BioTech Galcanezumab - 120mg/ml 120mg/ml Injectable suspension 37,250,732 L.L
L01FE01 ERBITUX BioTech Cetuximab - 100mg/20ml 100mg/20ml Injectable solution L.L
J01MA02 ESTECINA 200MG G Ciprofloxacine (lactate) - 200mg/100ml 200mg/100ml Injectable solution 32,190,251 L.L
J01MA12 EVOXIL HELLAS G Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 959,504 L.L
B02AA02 EXACYL B Tranexamic acid - 500mg/5ml 500mg/5ml Injectable solution 748,520 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 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 56,780,638 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 39,269,439 L.L
L04AB01 ENBREL BioTech Etanercept - 25mg 25mg Injectable solution 28,768,353 L.L
L04AB01 ERELZI BioTech Etanercept - 25mg 25mg Injectable solution 24,770,928 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
L01BA01 EBETREXAT G Methotrexate - 50mg/5ml 50mg/5ml Injectable solution 1,507,821 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) TWIN BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) SINGLE BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
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B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 2000UI/ml 2000UI/ml Injectable solution 7,849,606 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000UI/ml 4000UI/ml Injectable solution 1,243,054 L.L
B03XA01 EPOTEX 4000 BENTA BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable solution 1,209,458 L.L
B03XA01 EPOTEX 4000 BENTA BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable solution 5,488,046 L.L
B03XA01 EPREX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU/0.4ml 4,000IU/0.4ml Injectable solution 15,187,737 L.L
L04AX03 EBETREXAT G Methotrexate - 15mg/1.5ml 15mg/1.5ml Injectable solution 2,135,366 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10000UI/ml 10000UI/ml Injectable solution 2,486,109 L.L
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