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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
L01DB01 CAELYX B Doxorubicin HCl pegylated liposomes - 20mg/10ml 20mg/10ml Injectable concentrated solution L.L
L01EG02 EVEROLIMUS BIOGARAN G Everolimus - 5mg 5mg Tablet L.L
L01EG02 EVEROLIMUS BIOGARAN G Everolimus - 10mg 10mg Tablet L.L
L01EF01 PAPILLIO G Palbociclib - 125mg 125mg Capsule, hard L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution L.L
L01BC07 VIDAZA B Azacitidine - 100mg 100mg Injectable lyophilised powder L.L
L01EJ01 CELEZON G Ruxolitinib - 5mg 5mg Tablet L.L
L01EJ01 CELEZON G Ruxolitinib - 15mg 15mg Tablet L.L
L01EJ01 CELEZON G Ruxolitinib - 20mg 20mg Tablet L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule L.L
L04AX06 IMNOVID B Pomalidomide - 4mg 4mg Capsule, hard L.L
L01FD01 TRASTUREL BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder L.L
L01FG01 BEVACIREL BioTech Bevacizumab - 400mg/16ml 400mg/16ml Injectable solution L.L
L01FG01 BEVACIREL BioTech Bevacizumab - 100mg/4ml 100mg/4ml Injectable solution L.L
L04AB01 ETANERREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution L.L
L01FA01 RITUXIREL BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrated solution L.L
L01EL01 DULLARMA G Ibrutinib - 140mg 140mg Capsule, hard L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet L.L
L04AA18 CERTICAN B Everolimus - 0.75mg 0.75mg Tablet L.L
L01EX02 NEXAVAR B Sorafenib - 200mg 200mg Tablet, film coated L.L
L01FE01 ERBITUX BioTech Cetuximab - 100mg/20ml 100mg/20ml Injectable solution L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
L02AE03 ZOLADEX LA B Goserelin (acetate) - 10.8mg 10.8mg Injectable suspension L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
R05CB13 PULMOZYME BioTech Dornase alfa (desoxyribonuclease) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution L.L
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