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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
S01AA13 OPTIFUCIN VISCOUS G Fusidic acid - 1% 1% Drops 208,296 L.L
A02BC03 JOSWE LANZOTEC 30 G Lansoprazole - 30mg 30mg Capsule 271,456 L.L
A08AB01 LESSFAT G Orlistat - 120mg 120mg Capsule 391,634 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 20g/100ml 20g/100ml Injectable solution 807,874 L.L
C10AA07 APO-ROSUVASTATIN G Rosuvastatin (calcium) - 20mg 20mg Tablet 670,577 L.L
D10AE01 BENZAC AC G Benzoyl peroxide - 5g/100g 5% Gel 388,370 L.L
J01DC02 CEFUZIME G Cefuroxime (axetil) - 500mg 500mg Tablet, film coated 490,503 L.L
J01MA12 MATADOR G Levofloxacin - 750mg 750mg Tablet, film coated 1,126,140 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (25mg) 2.5mg/ml Injectable powder for concentrate for solution 24,934,922 L.L
L04AA32 APRIVA G Apremilast - 30mg 30mg Tablet, film coated 41,455,526 L.L
M01AH01 JOSWE FLAMEX 400 G Celecoxib - 400mg 400mg Capsule 1,659,645 L.L
N02BE01 SICADOL G Paracetamol - 1000mg 1000mg Tablet 423,310 L.L
N04BD02 RAZYLECT 1 G Rasagiline mesylate - 1mg 1mg Tablet 3,532,514 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
A02BC03 JOSWE LANZOTEC 30 G Lansoprazole - 30mg 30mg Capsule 514,692 L.L
A08AB01 ONLEFIT G Orlistat - 120mg 120mg Capsule 1,537,356 L.L
A11CC05 ALTO D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 4 1/4% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 4.25g% Injectable solution 498,744 L.L
C09CA06 ANDESART 16 G Candesartan cilexetil - 16mg 16mg Tablet 665,202 L.L
C10AA07 CONSIVAS 20 G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 450,187 L.L
D10AF01 MEDACIN T G Clindamycin (phosphate) - 10mg/ml 10mg/ml Solution 314,459 L.L
G04BX14 DEPOJOY G Dapoxetine (hydrochloride) - 60mg 60mg Tablet, film coated 1,565,577 L.L
J01DC02 ZINOXIMOR G Cefuroxime (axetil) - 500mg 500mg Tablet, film coated 698,798 L.L
J01MA12 TAVAQUIN G Levofloxacin (hemihydrate) - 750mg 750mg Tablet, film coated 1,389,533 L.L
N04BD02 RAZYLECT 0.5 G Rasagiline mesylate - 0.5mg 0.5mg Tablet 2,036,369 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
A02BC03 LPZ-30 G Lansoprazole - 30mg 30mg Capsule, delayed release 360,150 L.L
A08AB01 ORLISTAT-SIGMA G Orlistat - 120mg 120mg Capsule 847,965 L.L
A11CC05 ALTUM-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 561,342 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 1 1/2% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 1.5g% Injectable solution 490,807 L.L
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