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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
R06AB52 HISTAMED-F G Dexchlorpheniramine - 2mg/5ml, Dexamethasone - 0.25mg/5ml Syrup 712,876 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine maleate - 2mg, Dexamethasone - 0.25mg, Fluphenazine HCl - 0.25mg Tablet, coated 579,772 L.L
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
R06AA52 HISTALIX G Diphenhydramine HCl - 14mg/5ml, Ammonium chloride - 135mg/5ml, Menthol - 1.1mg/5ml Syrup 405,840 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract (Hedera Helix) - 99mg/5ml 99mg/5ml Drops solution 384,339 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
R05CA12 HEDECTON COUGH G Ivy leaf soft extract - 40mg/5ml Syrup 467,657 L.L
R02AA20 HEXASPRAY COLLUTOIRE PRESSURISE B Biclotymol - 750mg 750mg Spray 353,431 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
N05AD01 HALDOL B Haloperidol - 5mg 5mg Tablet 231,141 L.L
N05AD01 HALOPERIDOL G Haloperidol - 5mg 5mg Tablet 276,448 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
N05AD01 HALOPERIDOL G Haloperidol - 2mg 2mg Tablet 252,130 L.L
N05AD01 HALOPERIDOL G Haloperidol - 10mg 10mg Tablet 339,160 L.L
N05AD01 HALOPERIDOL G Haloperidol - 20mg 20mg Tablet 339,160 L.L
N02BE51 HUMACE PLUS G Paracetamol - 500mg, Aceclofenac (potassium) - 200mg Tablet 575,165 L.L
N02BE51 HUMEXLIB PARACETAMOL CHLORPHENAMINE B Paracetamol - 500mg, Chlorphenamine maleate - 4mg Capsule 598,010 L.L
N02BE51 HUMEX RHUME B Pseudoephedrine HCl (tablet) - 60mg, Paracetamol (tablet) - 500mg, Paracetamol (capsule) - 500mg, Chlorphenamine maleate (capsule) - 4mg Tablet, capsule 467,657 L.L
M09AX01 HYALGAN B Hyaluronic acid (sodium) - 20mg/2ml 20mg/2ml Injectable solution 3,407,985 L.L
M01AE03 HUMFINE G Ketoprofen - 100mg/2ml 100mg/2ml Injectable solution 3,514,148 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 33,860,031 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution 38,083,434 L.L
L01FD01 HERCEPTIN BioTech Trastuzumab - 440mg 21mg/ml Injectable concentrated powder for solution+diluent 166,423,476 L.L
L01FD01 HERCEPTIN BioTech Trastuzumab - 440mg 21mg/ml Injectable concentrated powder for solution+diluent 166,423,476 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 440mg 440mg Injectable powder for concentrate for solution 89,046,707 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 150mg 150mg Injectable powder for concentrate for solution 36,062,671 L.L
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