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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
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 2400IU, Blood Coagulation Factor VIII - 1000IU Injectable lyophilised powder for solution+diluent 49,643,758 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent 33,698,319 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 60mg/0.4ml 60mg/0.4ml Injectable solution 441,042,377 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution 224,585,721 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 150mg/ml 150mg/ml Injectable solution 716,437,779 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 105mg/0.7ml 105mg/0.7ml Injectable solution 577,741,643 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 940,690 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 33,852,747 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable freeze dried substance+diluent 2,490,140 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 L.L
B05AA01 HUMAN ALBUMIN "OCTAPHARMA" 20% BioHuman Albumin human - 20% 20% Injectable solution 4,863,366 L.L
B05AA01 HUMAN ALBUMIN 20% SOLUTION BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05BB02 HI-SODIUM WITHOUT POTASSIUM INJECTION G Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 166,708 L.L
B05BB02 HI-SODIUM INJECTION G Sodium lactate - 0.223g%, Sodium dihydrogenophosphate - 0.137g%, Potassium chloride - 0.149g%, Sodium chloride - 0.175g%, Dextrose, H2O - 5.0g% Injectable solution 176,024 L.L
B05BB02 HI-SODIUM INJECTION WITH POTASSIUM G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
C03BA04 HYGROTON B Chlortalidone - 50mg 50mg Tablet 422,351 L.L
C03DA04 HEPERONA 25 G Eplerenone - 25mg 25mg Tablet, coated 2,116,552 L.L
C03DA04 HEPERONA 50 G Eplerenone - 50mg 50mg Tablet, coated 2,150,148 L.L
C05AX HEMOCARE G Bismuth subgallate - 100mg, Zinc oxide - 100mg, Lidocaine - 60mg Suppository 588,731 L.L
C08CA01 HYPODIPINE 5 G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 L.L
C09DA01 HYZAAR B Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet 1,523,022 L.L
C09DA01 HYZAAR B Losartan potassium - 100mg, Hydrochlorothiazide - 12.5mg Tablet 1,740,596 L.L
D03AX HEALIN B G ?-sitosterol - 0.25% 0.25% Ointment 849,820 L.L
D04AA32 HISTERGAN G Diphenhydramine HCl - 2% 2% Cream 546,944 L.L
D04AA32 HISTAFEN G Diphenhydramine HCl - 2% 2% Solution 362,837 L.L
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