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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
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 284,997 L.L
J01FF01 CLINDAMYCIN-HAMELN G Clindamycin (phosphate) - 600mg/4ml 150mg/ml Injectable solution 3,535,650 L.L
J06BA02 HIZENTRA 4G BioHuman Immunoglobulin human - 4g/20ml 20% Injectable solution 35,323,423 L.L
N02AA01 MORPHINE MEDIS G Morphine HCl - 10mg/ml 10mg/ml Injectable solution 1,050,885 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 220,643 L.L
C02CA06 TACHYBEN G Urapidil - 25mg/5ml 25mg/5ml Injectable solution 1,439,255 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 80mg/2ml 80mg/2ml Injectable solution 721,643 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 1g/20ml 1g/20ml Injectable solution 7,474,948 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 252,820 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 80mg/2ml 80mg/2ml Injectable solution 721,643 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 165,482 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
J06BB01 RHOPHYLAC 300 BioHuman Human anti-D (rh) immunoglobulin - 300mcg/2ml 300mcg/2ml Injectable solution 5,939,784 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 170,630 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
J06BB01 RHESONATIV BioHuman Human anti-D (rh) immunoglobulin - 625IU/ml 625IU/ml Injectable solution 12,281,758 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 194,211 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
J06BB02 TETAGAM P BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 2,958,325 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 219,493 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
J06BB02 TETANUS GAMMA BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 3,077,399 L.L
N02AA05 OXYCODONE RENAUDIN G Oxycodone HCl - 10mg/10ml 10mg/10ml Injectable solution 2,432,355 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 170,630 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 100UI/ml 100UI/ml Injectable solution 6,853,730 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 252,820 L.L
J01GB06 MIACIN G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 2,015,764 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 500UI/5ml 500UI/5ml Injectable solution 26,599,935 L.L
    ...
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