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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
J01CA04 AMOXICILLINE PANPHARMA G Amoxicillin (sodium) - 1g 1g Injectable powder for solution 2,734,719 L.L
J01FA10 AZICIN 250 BENTA G Azithromycin - 250mg 250mg Tablet, film coated 423,630 L.L
L02BG04 FEMAZOL G Letrozole - 2.5mg 2.5mg Tablet, film coated 1,433,432 L.L
M01AC02 SORAL G Tenoxicam - 20mg/2ml 20mg/2ml Injectable lyophilised powder for solution+solvent 588,603 L.L
N03AX16 PLENICA G Pregabalin - 150mg 150mg Capsule 997,131 L.L
N06AB03 OXETINE 20 G Fluoxetine (HCl) - 20mg 20mg Tablet, coated 362,837 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 0.5mg/ml 0.5mg/ml Solution 1,158,264 L.L
A04AA01 NAUSETRON G Ondansetron - 4mg/5ml 4mg/5ml Solution 958,608 L.L
B01AC06 ASPICOT G Acetylsalicylic acid - 100mg 100mg Tablet, enteric coated 403,153 L.L
B05BB02 DEXTROSE 2.5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 2.5% Injectable solution 185,018 L.L
C01DA08 ISDN G Isosorbide dinitrate - 10mg 10mg Tablet 311,771 L.L
J01CA04 MOXILEN G Amoxicillin (sodium) - 1g 1g Injectable dry powder for solution 998,475 L.L
J01FA10 AZIFAST 250 G Azithromycin - 250mg 250mg Tablet, film coated 423,630 L.L
L02BG04 LEFFTARA G Letrozole - 2.5mg 2.5mg Tablet, film coated 2,060,111 L.L
M01AC56 MOBITIL G Meloxicam - 15mg, Beta-cyclodextrine - 75mg Tablet, film coated 212,327 L.L
N03AX16 PMS-PREGABALIN G Pregabalin - 150mg 150mg Capsule 2,534,487 L.L
N06AB03 PMS-FLUOXETINE G Fluoxetine (HCl) - 20mg 20mg Capsule 592,635 L.L
R06AE55 VOMINORE-JPM G Meclozine HCl - 25mg, Pyridoxine HCl - 50mg Tablet 259,362 L.L
L01EG02 EVEROLIMUS ARROW G Everolimus - 2.5mg 2.5mg Tablet L.L
A04AA01 NAUSETRON G Ondansetron - 4mg/5ml 4mg/5ml Solution 802,466 L.L
A10BD08 GLUNORM M G Metformin HCl - 1000mg, Vildagliptin - 50mg Tablet, film coated 1,089,856 L.L
B01AC06 ASPICOT G Acetylsalicylic acid - 100mg 100mg Tablet, enteric coated 134,384 L.L
B05BB02 DEXTROSE 2.5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 2.5% Injectable solution 174,675 L.L
C01DA08 ISODEX G Isosorbide dinitrate - 10mg 10mg Tablet 138,224 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 40mg 40mg Tablet, film coated 264,737 L.L
D06BB10 GENIMOD G Imiquimod - 5% 5% Cream 2,268,406 L.L
J01CE01 PENICILLINE G PANPHARMA G Benzylpenicillin (sodium) - 1,000,000IU 1,000,000IU Injectable powder for solution 2,858,353 L.L
J01FA10 AZOMYCIN G Azithromycin (dihydrate) - 250mg 250mg Capsule 361,494 L.L
L02BG04 LETROZOLE ARROW G Letrozole - 2.5mg 2.5mg Tablet, film coated 2,402,790 L.L
N02AA01 MORPHINE (CHLORHYDRATE) RENAUDIN G Morphine HCl - 1mg/ml 1mg/ml Injectable solution 626,231 L.L
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