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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
L01EA02 APO-DASATINIB G Dasatinib - 20mg 20mg Tablet 57,771,855 L.L
L01EA01 APO-IMATINIB G Imatinib - 100mg 100mg Tablet 38,330,537 L.L
L01CD01 ABRAXANE BioTech Paclitaxel Albumin- bound - 5mg/ml 5mg/ml Injectable powder for dispersion 17,850,751 L.L
L01BC07 AZACITIDINE ARROW G Azacitidine - 25mg/ml 25mg/ml Injectable suspension 10,967,854 L.L
L01BC07 AZACITIDINE EVER PHARMA G Azacitidine - 100mg/100ml 25mg/ml Injectable powder for suspension 10,967,854 L.L
L01BC07 AZACITIDINE NEAPOLIS G Azacitidine - 100mg 100mg Injectable lyophilised powder 9,401,575 L.L
L01BC07 AZACITIDINE SPC G Azacitidine - 100mg 100mg Injectable powder 10,706,993 L.L
L01BC01 ALEXAN G Cytarabine - 100mg/5ml 100mg/5ml Injectable solution 388,370 L.L
L01BC01 ALEXAN G Cytarabine - 1,000mg/20ml 1,000mg/20ml Injectable solution 2,848,946 L.L
L01BA04 ALIMTA B Pemetrexed (disodium) - 500mg 500mg Injectable concentrated powder for solution 75,811,351 L.L
L01BA04 ALIMTA B Pemetrexed (disodium) - 100mg 100mg Injectable concentrated powder for solution 16,854,009 L.L
J07BX05 ABRYSVO B RSV subgroup A stabilized perfusion F antigen 60mcg - 60mcg, RSV subgroup B stabilized perfusion F antigen 60mcg - 60mcg, Glycoprotein F stabilized in the perfusion conformation - Injectable powder + solvent 22,650,721 L.L
J07BC02 AVAXIM PEDIATRIQUE (vaccin inactivé de l'hépatite A adsorbé) B Hepatitis A, inactivated, whole virus - 80 antigen units/0.5ml 80 antigen units/0.5ml Injectable suspension 1,531,980 L.L
J06BA02 ARAGAM BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 38,549,017 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 1mg 1mg Tablet, film coated 31,285,380 L.L
J05AF10 APO-ENTECAVIR G Entecavir - 0.5mg 0.5mg Tablet 28,943,287 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 32,224,230 L.L
J05AB01 ASIMPLEX G Aciclovir - 250mg 250mg Injectable lyophilised powder for solution 278,175 L.L
J05AB01 ACTI-VIR G Aciclovir - 200mg 200mg Tablet, scored 1,039,238 L.L
J02AA01 AMBISOME B Liposomal Amphotericin B - 50mg 50mg Injectable powder for liposomal dispersion 13,126,040 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 1,087,169 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 1,521,230 L.L
J01MA14 AVITAR 400 G Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 913,813 L.L
J01MA14 AVITAR 400 G Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 651,764 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg/250ml 400mg/250ml Injectable solution 9,052,935 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
J01FA10 AZICIN 500 BENTA G Azithromycin - 500mg 500mg Tablet, film coated 573,373 L.L
J01FA10 AZIFAST 500 G Azithromycin - 500mg 500mg Tablet, film coated 573,373 L.L
J01FA10 AZM-500 G Azithromycin - 500mg 500mg Tablet, film coated 448,843 L.L
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