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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
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 5mcg/ml 10mcg/2ml Injectable solution 755,239 L.L
V03AF03 BENDAFOLIN G Calcium folinate - 200mg/20ml 200mg/20ml Injectable solution 3,584,028 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 2000IU Anti-XA/0.2ml 2000IU Anti-XA/0.2ml Injectable solution 388,370 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 189,262 L.L
C08CA04 NICARDIPINE ARROW G Nicardipine chlorhydrate - 10mg/10ml 10mg/10ml Injectable solution 2,590,928 L.L
M01AB05 OLFEN 75MG G Diclofenac sodium - 75mg 75mg Injectable solution 334,617 L.L
V03AF03 CALCIUMFOLINAT EBEWE G Calcium folinate - 100mg/10ml 100mg/10ml Injectable solution 1,289,872 L.L
B01AB05 LOVENOX BioTech Enoxaparin sodium - 2,000UI (20mg)/0.2ml 2,000UI (20mg)/0.2ml Injectable solution 467,657 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C08CA04 NICARDIPINE MEDIS G Nicardipine chlorhydrate - 10mg/10ml 10mg/10ml Injectable solution 1,295,464 L.L
M01AB05 VOLDEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 422,351 L.L
R06AA02 DIPHENIST G Diphenhydramine HCl - 50mg/ml 50mg/ml Injectable solution 6,977,230 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 100mg/10ml 10mg/ml Injectable solution 5,872,592 L.L
B01AB05 PARINOX 20 BioTech Enoxaparin sodium - 2000IU (20mg)/0.2ml 2000IU (20mg)/0.2ml Injectable solution 188,138 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,894 L.L
M01AB05 VOTREX G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 345,368 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 50mg/5ml 10mg/ml Injectable solution 5,305,490 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 10000IU Anti-XA/1ml 10000IU Anti-XA/1ml Injectable solution 1,209,458 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 198,578 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 226,036 L.L
N01AX03 KETAMINE PANPHARMA G Ketamine HCl - 250mg/5ml 250mg/5ml Injectable solution 1,534,668 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
L02AE04 GONAPEPTYL B Triptorelin acetate - 0.1mg 0.1mg Injectable solution 4,637,600 L.L
B01AB12 HIBOR G Bemiparin Sodium - 2,500IU 2,500IU Injectable solution 704,173 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 180,421 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 186,167 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/5ml 5mg/5ml Injectable solution 529,474 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
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