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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
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 795,555 L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet 3,006,579 L.L
L02BB06 NUBEQA B Darolutamide - 300mg Tablet, film coated 452,633,527 L.L
V07AB01 EAU POUR PREPARATIONS INJECTABLES RENAUDIN G Water for injection - Water for injection, irrigation 266,081 L.L
A10BD15 DIAFLOZIN PLUS G Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet, film coated 2,483,421 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 393,746 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 188,772 L.L
A10BD15 ZYGLOMET XR 10/1000 G Dapagliflozin - 10mg, Metformin HCl XR - 1000mg Tablet, film coated 2,467,295 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 550,821 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 203,481 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 10mg Tablet, film coated 4,162,216 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 50mg, Pridinol mesylate - 4mg Tablet, film coated 575,165 L.L
P03AX01 SPIDOGALE G Benzyl benzoate - 10g/100ml, Sulfur colloïdal - 5g/100ml Lotion 207,336 L.L
R06AD52 CODOPALM G Promethazine HCl - 5mg/5ml, Sodium gentisate - 0.5mg/5ml Syrup 149,742 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for injection - Water for injection, irrigation 264,311 L.L
A06AA01 HUILE DE PARAFFINE G Liquid paraffin - Liquid 207,336 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 10mg Tablet, film coated 4,162,216 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 75mg, Pridinol mesylate - 2.2mg Injectable solution 1,131,515 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 203,405 L.L
A10BD19 EMPAGLINE G Empagliflozin - 10mg, Linagliptin - 5mg Tablet, film coated 2,237,050 L.L
J01CR02 AMOXICLAV-ORBUCELL G Amoxicillin - 1g, Clavulanic Acid (potassium) - 0.2g Injectable powder for solution 7,433,691 L.L
M01AB55 DIFEN PLUS G Diclofenac potassium - 50mg, Betamethasone - 0.3mg Tablet, coated 503,941 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,162,216 L.L
M01AB55 DIFEN B12 G Diclofenac potassium - 50mg, Betamethasone - 0.3mg, Cyanocobalamin - 5mg Tablet 503,941 L.L
V07AB01 STERILE WATER FOR IRRIGATION G Water for Irrigation - Water for injection, irrigation 203,481 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,162,216 L.L
J01CR02 VAAMOX IV G Amoxicillin - 1g, Clavulanic Acid - 200mg Injectable powder 225,766 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,104,639 L.L
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 2,706,319 L.L
    ...
    182
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