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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
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release 68,645,618 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release 25,729,044 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 5mg 5mg Capsule, prolonged release 85,485,667 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 0.5mg 0.5mg Capsule, prolonged release 13,297,758 L.L
L04AC07 ACTEMRA BioTech Tocilizumab - 80mg/4ml 80mg/4ml Injectable concentrated solution 11,127,864 L.L
L04AC07 ACTEMRA BioTech Tocilizumab - 162mg/0.9ml 162mg/0.9ml Injectable solution 79,959,812 L.L
L04AC07 ACTEMRA BioTech Tocilizumab - 200mg/10ml 200mg/10ml Injectable concentrated solution 25,485,937 L.L
L04AC07 ACTEMRA BioTech Tocilizumab - 400mg/20ml 400mg/20ml Injectable concentrated solution 47,925,322 L.L
L04AB04 ABRILADA BioTech Adalimumab - 40mg 40mg Injectable solution 40,259,574 L.L
L04AB04 ABRILADA BioTech Adalimumab - 40mg 40mg Injectable solution 40,259,574 L.L
L04AB04 ADALIREL BioTech Adalimumab - 40mg 40mg Injectable solution 15,102,158 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 14,833,767 L.L
L04AB01 ALTEBREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 27,383,989 L.L
L04AA32 APRIVA STARTER PACK G Apremilast - 10mg, Apremilast - 20mg, Apremilast - 30mg Tablet, film coated 22,154,866 L.L
L04AA32 APRIVA G Apremilast - 30mg 30mg Tablet, film coated 41,455,526 L.L
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 L.L
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 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
L03AB07 AVONEX BioTech Interferon beta-1a - 30mcg/0.5ml 30mcg/0.5ml Injectable solution 70,488,764 L.L
L02BX03 ABIRATERONE ACETATE NEAPOLIS G Abiraterone acetate - 250mg 250mg Tablet 75,418,662 L.L
L02BX03 ABIRATERONE ACETATE SPC G Abiraterone acetate - 250mg 250mg Tablet, film coated 92,278,660 L.L
L02BX03 ABLAX 250 G Abiraterone acetate - 250mg 250mg Tablet 45,056,853 L.L
L02BX03 ABREMIA G Abiraterone acetate - 250mg 250mg Tablet 77,478,802 L.L
L02BX03 ABLAX 500 G Abiraterone acetate - 500mg 500mg Tablet 45,056,853 L.L
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