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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
D10BA01 CONTRACNE ISOTRETINOINE G Isotretinoin - 40mg 40mg Capsule, soft 3,043,803 L.L
G04CB02 DUTASTERIDE BIOGARAN G Dutasteride - 0.5mg 0.5mg Capsule, soft 1,112,702 L.L
A11CC06 HIDROFEROL G Calcifediol - 0.266mg 0.266mg Capsule, soft 1,316,966 L.L
B01AB11 ANGIOFLUX G Sulodexide - 250LRU 250LRU Capsule, soft 2,026,514 L.L
L02BB04 XTANDI B Enzalutamide - 40mg 40mg Capsule, soft 267,649,535 L.L
A03AA04 SPASMINE (Mebeverine HCl 200mg SR) G Mebeverine HCl - 200mg 200mg Capsule, slow release 712,876 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 75mg 75mg Capsule, prolonged release 564,414 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 75mg 75mg Capsule, prolonged release 564,414 L.L
N06AX16 VENLAFAXINE BIOGARAN LP G Venlafaxine HCl - 75mg 75mg Capsule, prolonged release 584,571 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
N06AX16 VENLAFAXINE BIOGARAN LP G Venlafaxine HCl - 37.5mg 37.5mg Capsule, prolonged release 538,881 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release 68,645,618 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release 25,729,044 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 5mg 5mg Capsule, prolonged release 85,485,667 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 0.5mg 0.5mg Capsule, prolonged release 13,297,758 L.L
M01AB05 OLFEN-100 SR G Diclofenac sodium - 100mg 100mg Capsule, prolonged release 503,941 L.L
G04CA02 PROSTAFINE G Tamsulosin HCl - 0.4mg 0.4mg Capsule, modified release 761,511 L.L
G04CA02 TALUSIN G Tamsulosin HCl - 0.4mg 0.4mg Capsule, modified release 683,440 L.L
C08DA51 TARKA B Verapamil - 180mg, Trandolapril - 2mg Capsule, modified release 2,422,948 L.L
G04BD06 MICTONORM XL B Propiverine HCl - 30mg 30mg Capsule, modified release 1,648,895 L.L
G04BD06 MICTONORM XL B Propiverine HCl - 45mg 45mg Capsule, modified release 1,877,348 L.L
C10AB05 FENOGAL G Fenofibrate micronised - 200mg 200mg Capsule, micronized 392,402 L.L
A03AX13 OVOL FOR GAZ B Simethicone - 180mg 180mg Capsule, liquid gel 241,892 L.L
R03AC18 ONBREZ BREEZHALER B Indacaterol maleate - 150mcg 150mcg Capsule, inhalation 2,284,532 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 100mcg Capsule, inhalation 1,709,989 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 250mcg Capsule, inhalation 2,393,122 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 500mcg Capsule, inhalation 3,048,930 L.L
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