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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
L01BB06 EVOLTRA B Clofarabine - 1mg/ml 1mg/ml Injectable concentrate for solution 91,416,937 L.L
M03AC09 ESMERON B Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 4,949,372 L.L
M03AC09 ESMERON B Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 4,750,483 L.L
L01BC02 EFUDIX B Fluorouracil - 5% 5% Cream 671,921 L.L
N06DA03 EXELON TRANSDERMAL PATCH 10 B Rivastigmine - 9.5mg/24h 9.5mg/24h Patch 2,457,888 L.L
N06DA03 EXELON TRANSDERMAL PATCH 5 B Rivastigmine - 4.6mg/24h 4.6mg/24h Patch 2,457,888 L.L
N06DA03 EXELON TRANSDERMAL PATCH 15 B Rivastigmine - 13.3mg/24h 13.3mg/24h Patch 7,582,922 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions/5ml Suspension 1,131,515 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions/5ml Suspension 595,322 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions Capsule 831,839 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,493,009 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,343,843 L.L
N06DX01 EBIXA B Memantine HCl - 10mg 10mg Tablet, film coated 2,143,429 L.L
N06DX01 EBIXA B Memantine - 20mg 20mg Tablet, film coated 4,004,651 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 25mg Tablet, film coated 1,846,440 L.L
C09DB01 EXFORGE B Amlodipine - 5mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
N03AB02 EPANUTIN B Phenytoin sodium - 100mg 100mg Capsule 739,113 L.L
C09DB01 EXFORGE B Amlodipine - 10mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
D01AE22 EXODERIL B Naftifine HCl - 10mg/g 1% Cream 345,368 L.L
D01AE22 EXODERIL B Naftifine HCl - 10ml/ml 1% Solution 159,917 L.L
J02AX06 ECALTA B Anidulafungin - 100mg 100mg Injectable concentrated powder for solution 16,977,343 L.L
L01XA03 ELOXATIN B Oxaliplatin - 50mg/10ml 50mg/10ml Injectable concentrated solution 4,930,558 L.L
G03AD02 ELLAONE B Ulipristal acetate - 30mg 30mg Tablet 2,276,469 L.L
R05CB01 EXOMUC B N-acetylcysteine - 200mg 200mg Granules for solution 588,603 L.L
G03CA03 ESTROFEM B Estradiol (hemihydrate) - 2mg 2mg Tablet, film coated 399,121 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 25mcg 25mcg Tablet, scored 256,674 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 50mcg 50mcg Tablet, scored 391,058 L.L
H03AA01 ELTROXIN B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 440,780 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 452,875 L.L
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