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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
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 9,338,600 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 205,933 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
P01AB01 METRO-SOLUTIONS G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 166,381 L.L
V03AB35 PLIBADEX G Sugammadex - 200mg/2ml 500mg/5ml Injectable solution 46,089,190 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
M05BX04 PROLIA BioTech Denosumab - 60mg/ml 60mg/ml Injectable solution 21,603,638 L.L
P01AB01 POLGYL G Metronidazole - 0.5% 0.5% Injectable solution 134,384 L.L
V03AB37 PRAXBIND BioTech Idarucizumab - 50mg/ml 50mg/ml Injectable solution 287,986,627 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,018,089 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 217,210 L.L
C01CA03 NORADRENALINE RENAUDIN G Norepinephrine tartrate - 8mg/4ml 0.2% Injectable solution 2,000,981 L.L
J01DH51 CELLABAXIN G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable solution 10,699,559 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 10mg/5ml 10mg/5ml Injectable solution 822,636 L.L
M05BX04 XGEVA BioTech Denosumab - 120mg 120mg Injectable solution 33,545,669 L.L
P01AB01 SOLUFLEX METRONIDAZOLE G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,541 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 8mg/4ml 8mg/4ml Injectable solution 1,919,007 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 240,255 L.L
C01CA03 ? NORADRENALINE G Norepinephrine tartrate - 8mg/4ml 8mg/4ml Injectable solution 330,201 L.L
J01DH51 CILANEM G Imipenem anhydrous - 500mg, Cilastatin (sodium) - 500mg Injectable solution 850,652 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 3,765,140 L.L
M05BX06 EVENITY BioTech Romosozumab - 105mg/1.17ml 105mg/1.17ml Injectable solution 56,729,091 L.L
P01AB01 ? METRONIDAZOL G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,541 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,345,987 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 193,062 L.L
C01CA03 NORADRENALINE HIKMA G Noradrenaline bitartrate - 4mg/4ml 4mg/4ml Injectable solution 1,279,338 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 387,027 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 180,421 L.L
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