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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 ↓
L01EF01 PALBRANCE 125 G Palbociclib - 125mg 125mg Capsule L.L
L02BX03 ABLAX 250 G Abiraterone acetate - 250mg 250mg Tablet L.L
L01EX08 LENVIMA B Lenvatinib - 4mg 4mg Capsule, hard L.L
L01EX08 LENVIMA B Lenvatinib - 10mg 10mg Capsule, hard L.L
L01EF01 PAPILLIO G Palbociclib - 100mg 100mg Capsule, hard L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated L.L
L04AX04 REVLIMID B Lenalidomide - 10mg 10mg Capsule L.L
L01EA04 BOSULIF B Bosutinib - 500mg 500mg Tablet, film coated L.L
L01EA04 BOSULIF B Bosutinib - 400mg 400mg Tablet, film coated L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule L.L
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated L.L
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 62.5mg 62.5mg Tablet, film coated L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent L.L
L01FC01 DARZALEX BioTech Daratumumab - 400mg/20ml 400mg/20ml Injectable concentrate for solution L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft L.L
L01XG02 KYPROLIS B Carfilzomib - 60mg 60mg Injectable powder for solution L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution L.L
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