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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
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
H02AB09 HYDROCORTISON VUAB G Hydrocortisone hydrogenosuccinate - 100mg 100mg Injectable dry powder for solution 147,823 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
B01AB01 HEPARINE MEDIS G Heparin sodium - 25,000UI/5ml 25,000UI/5ml Injectable solution 6,853,597 L.L
B01AB01 HEPARINE SODIQUE PANPHARMA G Heparin sodium - 25,000IU/5ml 25,000IU/5ml Injectable solution 6,134,641 L.L
D03AX HEALIN B G ?-sitosterol - 0.25% 0.25% Ointment 849,820 L.L
C08CA01 HYPODIPINE 5 G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 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
J05AF10 HEPCAVIR 1 G Entecavir monohydrate - 1mg 1mg Tablet, film coated 18,998,515 L.L
J05AF10 HEPCAVIR 0.5 G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 18,998,515 L.L
R06AA52 HISTALIX G Diphenhydramine HCl - 14mg/5ml, Ammonium chloride - 135mg/5ml, Menthol - 1.1mg/5ml Syrup 405,840 L.L
B01AB12 HIBOR G Bemiparin Sodium - 2,500IU 2,500IU Injectable solution 704,173 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine - 2mg/5ml, Dexamethasone - 0.25mg/5ml Syrup 712,876 L.L
B01AB12 HIBOR G Bemiparin Sodium - 7,500IU 7,500IU Injectable solution 2,198,526 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine maleate - 2mg, Dexamethasone - 0.25mg, Fluphenazine HCl - 0.25mg Tablet, coated 579,772 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
D06BA51 HYALO4 PLUS G Hyaluronic acid (sodium) - 0.2%, Silver sulfadiazine - 1% Cream 466,313 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
D07AA02 HYDROCORTISONE ACETATE G Hydrocortisone acetate - 1% 1% Cream 215,015 L.L
A06AA01 HUILE DE PARAFFINE G Liquid paraffin - Liquid 207,336 L.L
A06AB05 HUILE DE RICIN G Castor oil - Liquid 163,821 L.L
M01AE03 HUMFINE G Ketoprofen - 100mg/2ml 100mg/2ml Injectable solution 3,514,148 L.L
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