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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
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 0.5% 0.5% Injectable solution 1,995,158 L.L
N05CD08 MIDAZOLAM PANPHARMA G Midazolam - 5mg/5ml 5mg/5ml Injectable solution 697,454 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 50mg/5ml 10mg/ml Injectable solution 5,305,490 L.L
A04AA05 VONAXI G Palonosetron HCl - 250mcg/5ml 250mcg/5ml Injectable solution 1,490,321 L.L
B05BB02 DEXTROSE 5% IN LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,404 L.L
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 1% 1% Injectable solution 1,995,158 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.2% G Sodium chloride - 0.2g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 194,165 L.L
M01AB15 ALGIKEY G Ketorolac trometamine - 30mg/ml 30mg/ml Injectable solution 873,498 L.L
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 1% 1% Injectable solution 1,995,158 L.L
N05CD08 IPNODIS MEDIS G Midazolam - 5mg/ml 5mg/ml Injectable solution 565,758 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.2% G Sodium chloride - 0.2g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
M01AB15 KETO-AVI G Ketorolac tromethamine - 30mg/ml 30mg/ml Injectable solution 106,164 L.L
N01BB02 ? 1% LIDOCAINE HCL USP G Lidocaine HCl - 1% 1% Injectable solution 76,791 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 561,726 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 188,772 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 30mg/2ml 30mg/2ml Injectable solution 106,164 L.L
N01BB02 CHLORHYDRATE DE LIDOCAINE RENAUDIN G Lidocaine (HCl) - 10mg/ml 1% Injectable solution 591,291 L.L
N05CD08 MIDAZOLAM PANPHARMA G Midazolam - 5mg/ml 5mg/ml Injectable solution 826,463 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 204,554 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 2.5g/50ml 2.5g/50ml Injectable solution 17,011,323 L.L
N01BB02 LIDOCAINE- ORBUCELL G Lidocaine HCl - 1% 1% Injectable solution 1,787,950 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
N01BB02 LIDOCAINE- ORBUCELL G Lidocaine HCl - 2% 2% Injectable solution 1,787,950 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 406,810 L.L
C01EB10 CARDESINE G Adenosine - 6mg/2ml 6mg/2ml Injectable solution 563,070 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 2.5g/25ml 10% Injectable solution 23,611,268 L.L
N01BB02 LIDOCAINE PANPHARMA 2% G Lidocaine (HCl) - 20mg/ml 2% Injectable solution 3,398,578 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
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