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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
N06AB06 SOLOTIK G Sertraline HCl - 100mg 100mg Tablet, film coated 616,824 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
J02AC01 STABILANOL G Fluconazole - 100mg 100mg Capsule 1,432,331 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 100mg 100mg Capsule, soft gelatin 8,264,592 L.L
N05AH04 SEROPINE 100 G Quetiapine fumarate - 100mg 100mg Tablet, film coated 1,996,950 L.L
N05AL05 SOLIAN B Amisulpride - 100mg 100mg Tablet, scored 1,048,197 L.L
N06BX06 SOMAZINA B Citicoline - 1000mg/sachet 1000mg/sachet Solution 974,286 L.L
A07EC02 SALOFALK B Mesalazine - 1000mg 1000mg Granules, gastro-resistant, prolonged release 3,874,298 L.L
A07EC02 SALCROZINE G Mesalazine - 1000mg 1000mg Suppository 2,306,034 L.L
N02BE01 SICADOL G Paracetamol - 1000mg 1000mg Tablet 423,310 L.L
V01AA STALORAL B Allergen extracts - 10-300 IR ou IC/ml 10-300 IR ou IC/ml Solution 7,206,963 L.L
V01AA STALORAL B Allergen extracts - 10-100-100 IR ou IC/ml 10-100-100 IR ou IC/ml Solution 9,129,688 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 10% 10% Injectable solution 4,129,004 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 10% 10% Injectable solution 5,779,226 L.L
N01BB58 SEPTANEST ADRENALINEE B Articaine HCl - 72mg/1.8ml, Adrenaline (tartrate) - 0.033mg/1.8ml 1/100,000 Injectable solution 2,945,703 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 1.5mg 1.5mg Tablet, extended release 1,847,783 L.L
A07EC02 SALOFALK B Mesalazine - 1.5g 1.5g Granules, gastro-resistant, prolonged release 6,150,767 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
N06BX06 SOMAZINA B Citicoline (sodium) - 1,000mg/4ml 1,000mg/4ml Injectable solution 787,492 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.9mg/ml 0.9mg/ml Injectable solution 191,126,390 L.L
B05XA03 SODIUM CHLORIDE INJECTION/ DEMO G Sodium chloride - 0.9% w/v 0.9% w/v Injectable solution 1,182,581 L.L
B05XA03 SODIUM CHLORIDE INJECTION/ DEMO G Sodium chloride - 0.9% w/v 0.9% w/v Injectable solution 1,419,098 L.L
B05XA03 SODIUM CHLORIDE INJECTION/ DEMO G Sodium chloride - 0.9% w/v 0.9% w/v Injectable solution 567,102 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 156,288 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 165,482 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 176,974 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 163,184 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 156,288 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 4,143,943 L.L
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