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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
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 561,726 L.L
P02CF01 IVERMECTIN BENTA G Ivermectin - 6mg 6mg Tablet 470,985 L.L
R06AB54 DRAUDEX G Chlorphenamine maleate - 4mg, Phenylephrine - 5mg Tablet, sugar coated 166,381 L.L
V07AB01 EAU POUR PREPARATION INJ. G Water for injection - Water for injection, irrigation 3,385,139 L.L
A10BD15 DIAFLOZIN PLUS G Metformin HCl XR - 1000mg, Dapagliflozin - 5mg Tablet, film coated 1,241,710 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 188,772 L.L
C01DX16 NICORANDIL BIOGARAN G Nicorandil - 20mg 20mg Tablet 822,432 L.L
C09AA05 ACURIL G Ramipril - 5mg 5mg Tablet 614,136 L.L
C10AA03 APO-PRAVASTATIN G Pravastatin Sodium - 20mg 20mg Tablet 775,397 L.L
D06BB53 ACTI-VIR H G Aciclovir - 5%, Hydrocortisone acetate - 1% Cream 833,182 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 500mg/5ml 500mg/5ml Powder for suspension 218,854 L.L
J01FA10 AZOMYNE G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension 237,860 L.L
L01EA02 ELPIDA G Dasatinib - 50mg 50mg Tablet, film coated 127,364,905 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 30mg/2ml 30mg/2ml Injectable solution 106,164 L.L
N01BB02 CHLORHYDRATE DE LIDOCAINE RENAUDIN G Lidocaine (HCl) - 10mg/ml 1% Injectable solution 591,291 L.L
N03AX14 LEVIPHAR G Levetiracetam - 500mg 500mg Tablet, film coated 1,451,350 L.L
N05CD08 MIDAZOLAM PANPHARMA G Midazolam - 5mg/ml 5mg/ml Injectable solution 826,463 L.L
P02DA01 TAENIASAN G Niclosamide - 500mg 500mg Tablet 94,709 L.L
R06AD02 PROMETHAZINE HYDROCHLORIDE G Promethazine HCl - 5mg/5ml 5mg/5ml Syrup 204,776 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
A10BD15 DIVINUSMET XR G Dapagliflozin - 5mg, Metformin HCl XR - 1000mg Tablet, extended release 2,900,012 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 204,554 L.L
C01DX16 NICORANDIL BIOGARAN G Nicorandil - 20mg 20mg Tablet 822,432 L.L
C09AA05 APO-RAMIPRIL G Ramipril - 5mg 5mg Capsule 794,211 L.L
C10AA03 PRAVASTATINE ARROW G Pravastatin - 20mg 20mg Tablet, breakable 526,786 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 1g 1g Tablet, dispersible 940,690 L.L
J01FA10 ZOMAX G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension 258,018 L.L
L01EA02 APO-DASATINIB G Dasatinib - 20mg 20mg Tablet 57,771,855 L.L
N01BB02 LIDOCAINE- ORBUCELL G Lidocaine HCl - 1% 1% Injectable solution 1,787,950 L.L
N03AX14 LEVIPRAM 500 G Levetiracetam - 500mg 500mg Tablet, film coated 1,663,805 L.L
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