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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
S01FB01 PHENYLEPHRINE/ COOPER G Phenylephrine HCl - 10% 10% Drops solution 278,175 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 326,367 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 219,493 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 170,079 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 194,211 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 284,997 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 220,643 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 252,820 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 165,482 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 1,198,595 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 10,787,353 L.L
B05CX01 DEXTROSE 10% INJECTION, USP G Glucose - 10% 10% Injectable solution 217,195 L.L
B05CX01 DEXTROSE 10% INJECTION, USP G Glucose - 10% 10% Injectable solution 191,913 L.L
B05CX01 DEXTROSE 10% INJECTION, USP G Glucose - 10% 10% Injectable solution 168,929 L.L
J06BA02 GAMUNEX-C BioHuman Human normal immunoglobulin G - 10% 10% Injectable solution 39,990,287 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 5g/50ml 10% Injectable solution 44,463,925 L.L
D10AE01 BENZAC AC G Benzoyl peroxide - 10g/100g 10% Gel 416,591 L.L
A12AA03 10% W/V CALCIUM GLUCONATE INJECTION BP G Calcium gluconate - 10% 10% Injectable solution 3,952,241 L.L
A12AA03 CALCIUM GLUCONATE S.A.L.F G Calcium gluconate monohydrate - 10% 10% Injectable solution 389,714 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 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
D02AF POMMADE ACIDE SALICYLIQUE G Salicylic acid - 10% 10% Ointment 284,127 L.L
D04AB01 AVOCAINE G Lidocaine - 10% 10% Spray 400,465 L.L
D04AB01 PROCOMIL G Lidocaine - 10% 10% Spray 139,760 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
D05AA VASELINE ICHTYOLEE G Ichthyamol - 10% 10% Ointment 103,668 L.L
L01XX02 ERWINASE BioTech Erwinia L-asparaginase - 10,000IU 10,000IU Injectable lyophilised powder for solution 444,434,845 L.L
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