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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
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 10mg 10mg Granules, gastroresistant, for suspension 1,721,462 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 10mg 10mg Granules, gastroresistant, for suspension 1,721,462 L.L
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 20mg 20mg Capsule, soft gelatin 4,048,997 L.L
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 30mg 30mg Capsule, soft gelatin 6,072,824 L.L
J02AC04 NOXAFIL B Posaconazole - 100mg 100mg Tablet, gastroresistant 62,027,714 L.L
C07AB12 NEBILET B Nebivolol HCl - 5mg 5mg Tablet, scored 694,767 L.L
G02BA NUVARING B Etonogestrel - 0.12mg/day, Ethinylestradiol - 0.015mg/day Ring 1,052,229 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 716,268 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 716,268 L.L
L01XG03 NINLARO B Ixazomib - 4mg 4mg Capsule, hard 388,991,058 L.L
L01XG03 NINLARO B Ixazomib - 3mg 3mg Capsule, hard 348,420,676 L.L
L01XG03 NINLARO B Ixazomib - 2.3mg 2.3mg Capsule, hard 272,619,919 L.L
R05FA01 NEO-CODION B Codeine Camphosulfonate - 25mg, Sulfogaiacol - 100mg, Grindelia soft extract - 20mg Tablet, coated 286,238 L.L
C08CA06 NIMOTOP B Nimodipine - 30mg 30mg Tablet, film coated 581,884 L.L
L02BB06 NUBEQA B Darolutamide - 300mg Tablet, film coated 452,633,527 L.L
C01DA02 NITRODERM TTS 5 B Glyceryl trinitrate - 5mg/24h 5mg/24h Patch 654,183 L.L
R01AD09 NASONEX B Mometasone furoate (monohydrate) - 50mcg/dose 0.05% Spray, suspension 529,474 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
J07AH08 NIMENRIX B Polysaccharide of Neisseria meningitidis (serogroups A, C, Y and W-135) conjugated - 5mcg/0.5ml, Tetanus toxoid carrier protein - 44mcg/0.5ml Injectable lyophilised powder for solution+diluent 4,483,059 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution L.L
B02BD02 NOVOEIGHT BioTech Turoctocog Alfa - 500IU 500IU Injectable powder for solution+diluent 29,783,973 L.L
B02BD02 NUWIQ BioTech Coagulation Factor VIII recombinant, human (Simoctogog alfa) - 500IU 500IU Injectable powder for solution+diluent 45,612,427 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 2mg 2mg (100KIU) Injectable powder for solution+diluent 105,957,406 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent 57,890,287 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 5mg 5mg (250KIU) Injectable powder for solution+diluent 264,894,762 L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution 67,369,332 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 7,582,922 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
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