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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
M01AB05 EMIFENAC 50 G Diclofenac sodium - 50mg 50mg Tablet, dispersible 387,027 L.L
N03AX12 APO-GABAPENTIN G Gabapentin - 300mg 300mg Capsule 2,527,768 L.L
P01AB01 RAMAZOL G Metronidazole - 500mg 500mg Tablet 216,359 L.L
V03AC03 DEFERASIROX ARROW G Deferasirox - 360mg 360mg Tablet 18,379,327 L.L
A03FA01 ELITAN G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 252,642 L.L
A10BB12 DIAMERIL G Glimepiride - 2mg 2mg Tablet 199,657 L.L
B05BB01 LR G Sodium lactate - 0.3g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE E G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 7.00g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 205.49g/l Injectable solution L.L
C08CA01 AMOPRO G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable sterile lyophilised powder for solution 19,022,727 L.L
L01CE02 IRNOCAM 100 G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable solution 7,320,947 L.L
L01XX05 UNIDREA G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule, hard 2,539,862 L.L
M01AB05 ROFENAC D G Diclofenac free acid - 50mg 50mg Tablet, dispersible 408,528 L.L
N03AX12 GABAMOX G Gabapentin - 300mg 300mg Capsule, hard 1,108,670 L.L
V03AC03 DEFEROXAL 360 G Deferasirox - 360mg 360mg Tablet, film coated 24,918,561 L.L
A03FA01 METOCLOPRAMIDE S.A.L.F. G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 255,330 L.L
A10BB12 GLIM G Glimepiride - 2mg 2mg Tablet 401,809 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 232,134 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE F G Potassium chloride - 3.914g/l, Magnesium chloride, 6H2O - 3.558g/l, Calcium chloride, 2H2O - 7.719g/l, Acetic acid 100% - 6.010ml/l, Sodium chloride - 208.631g/l Injectable solution L.L
C08CA01 HYPODIPINE 5 G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 L.L
C09DB04 TWINCARD 80/5 G Telmisartan - 80mg, Amlodipine - 5mg Tablet 1,372,511 L.L
D03BA SERODASE G Serratiopeptidase - 5mg 5mg Tablet, enteric coated 460,938 L.L
J01DH02 MEROLIN G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 2,311,146 L.L
J05AF07 TENOFOVIR DISOPROXIL ARROW G Tenofovir disoproxil - 245mg 245mg Tablet, film coated 9,747,613 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable concentrated solution 2,123,271 L.L
M01AB05 DICLO-DENK 100 RETARD G Diclofenac sodium - 100mg 100mg Tablet, sustained release 1,756,402 L.L
M09AX NUCLEO C.M.P. FORTE G UTP+UDP+UMP - 3mg, CMP - 5mg Capsule 448,843 L.L
N03AX12 GABANET 300 G Gabapentin - 300mg 300mg Capsule 1,380,126 L.L
P01AB01 METROLAG G Metronidazole - 250mg 250mg Tablet 130,353 L.L
R05X BROMEX G Pyrilamine Maleate (Mepyramine) - 12.5mg/5ml, Bromhexine HCl - 4mg/5ml Elixir 250,851 L.L
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