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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
A07FA02 ULTRA LEVURE B Saccharomyces boulardii - 200mg 200mg Capsule 513,348 L.L
C04AX21 NAFTILUX B Naftidrofuryl oxalate acid - 200mg 200mg Capsule 432,717 L.L
A07FA51 INFLORAN B Bifidobacterium infantis - 1milliard, Lactobacillus acidophilus - 1milliard Capsule 647,732 L.L
A11AA VITA-FERIN C G Manganese sulfate - 0.77mg, Copper sulfate - 0.72mg, Iron fumarate - 0.022g, Vitamin C - 0.15g, Vitamin B5 - 0.01g, Vitamin B3 - 0.022g, Vitamin B6 - 0.002g, Vitamin B2 - 0.002g, Vitamin B1 - 0.01g Capsule 1,217,521 L.L
L01EL02 CALQUENCE B Acalabrutinib - 100mg 100mg Capsule 650,653,454 L.L
L04AA27 GILENYA B Fingolimod - 0.5mg 0.5mg Capsule 159,392,560 L.L
A07XA04 RACECADOTRIL ARROW G Racecadotril - 100mg 100mg Capsule 583,228 L.L
J01DB05 BIODROXIL G Cefadroxil (monohydrate) - 500mg 500mg Capsule 477,474 L.L
A07XA04 RACECADOTRIL BGR G Racecadotril - 100mg 100mg Capsule 575,165 L.L
J01DB05 CEFADRIL G Cefadroxil (monohydrate) - 500mg 500mg Capsule 450,187 L.L
L04AA27 PMS-FINGOLIMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 19,351,580 L.L
A07XA04 RACECADOTRIL BIOGARAN CONSEIL G Racecadotril - 100mg 100mg Capsule 287,582 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
J01DB05 ROXIL G Cefadroxil (monohydrate) - 500mg 500mg Capsule 869,466 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 12.5mg 12.5mg Capsule 36,042,560 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 943,377 L.L
A08AB01 ELIZA 120 G Orlistat - 120mg 120mg Capsule 1,711,159 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 942,034 L.L
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
M01AH01 CELECOXIB BIOGARAN G Celecoxib - 100mg 100mg Capsule 318,491 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
L01EX01 SOVIDEX G Sunitinib maleate - 25mg 25mg Capsule 64,804,314 L.L
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