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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
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 31,085,276 L.L
M01AB05 OLFEN-75 SR G Diclofenac sodium - 75mg 75mg Tablet, prolonged release 326,554 L.L
N03AX12 PMS-GABAPENTIN G Gabapentin - 400mg 400mg Capsule 1,071,042 L.L
N05BA12 ALPROX G Alprazolam - 0.5mg 0.5mg Tablet 383,955 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer carbonate - 800mg 800mg Tablet, film coated 8,645,754 L.L
A04AA01 VOMITRON G Ondansetron - 16mg 16mg Suppository 304,604 L.L
A10BD08 VLUDIN MET G Metformin HCl - 850mg, Vildagliptin - 50mg Tablet, film coated 735,914 L.L
B01AC24 KLOTEGO G Ticagrelor - 90mg 90mg Tablet, film coated 2,598,096 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
C01DA02 NITROJECT INJECTION G Nitroglycerine - 50mg/10ml 50mg/10ml Injectable solution 7,018,889 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 20mg 20mg Tablet, film coated 542,912 L.L
D06BA02 CREM-O-SULFA G Sulfathiazole - 5% 5% Cream 202,216 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 1g 1g Injectable powder for solution 2,857,009 L.L
J01FA09 CLAREM 500 G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
J05AR03 EMZAVIR G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg Tablet, film coated 18,701,506 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 16,360,672 L.L
L02BA03 FLUVESTRANT ARROW G Fulvestrant - 250mg/5ml 250mg/5ml Injectable solution 12,162,315 L.L
N01AX03 KETAMINE PANPHARMA G Ketamine HCl - 250mg/5ml 250mg/5ml Injectable solution 1,534,668 L.L
N03AX12 GABATREX G Gabapentin - 100mg 100mg Capsule 292,958 L.L
N05BA12 PAZOLAM G Alprazolam - 0.5mg 0.5mg Tablet 563,070 L.L
R05X COLDIN-H G Paracetamol - 300mg, Mepyramine maleate - 15mg, Noscapine - 10mg Capsule 386,515 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer - 2.4g 2.4g Powder for suspension 12,969,932 L.L
B01AC24 KLOTEGO G Ticagrelor - 90mg 90mg Tablet, film coated 2,598,096 L.L
B05BB02 DEXTROSE 2.5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 2.5% Injectable solution 148,566 L.L
C01DA02 TRINITRINA G Nitroglycerine - 50mg/50ml 50mg/50ml Injectable concentrate for solution 6,212,584 L.L
C10AA01 STAVINE G Simvastatin - 20mg 20mg Tablet 207,336 L.L
D06BA05 NEO SULFA G Sulfanilamide - 12g 12g Powder 151,022 L.L
J01CA04 AMOXICILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 6,199,145 L.L
J01FA09 ERACID 500 G Clarithromycin - 500mg 500mg Tablet, film coated 628,918 L.L
J05AR06 VITRICOMB G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg, Efavirenz - 600mg Tablet, film coated 22,191,783 L.L
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