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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
B01AB05 ENOMEX BioTech Enoxaparin sodium - 8000U Anti-Xa/0.8ml 8000U Anti-Xa/0.8ml Injectable solution 1,025,160 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 8000IU Anti-XA/0.8ml 8000IU Anti-XA/0.8ml Injectable solution 963,535 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 8000IU Anti-XA/0.8ml 8000IU Anti-XA/0.8ml Injectable solution 4,575,784 L.L
B01AB05 PARINOX 80 BioTech Enoxaparin sodium - 8000IU (80mg)/0.8ml 8000IU (80mg)/0.8ml Injectable solution 494,022 L.L
J07BC02 AVAXIM PEDIATRIQUE (vaccin inactivé de l'hépatite A adsorbé) B Hepatitis A, inactivated, whole virus - 80 antigen units/0.5ml 80 antigen units/0.5ml Injectable suspension 1,531,980 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
B01AB05 ENOXA MEDIS BioTech Enoxaparin sodium - 8,000U Anti-Xa/0.8ml 8,000U Anti-Xa/0.8ml Injectable solution 963,535 L.L
D11AX18 DILO G Diclofenac sodium - 8% 8% Spray 502,981 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
G03DA04 CRINONE B Progesterone - 8% 8% Gel 4,734,357 L.L
M01AB05 ALMIRAL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 415,247 L.L
M01AB05 CLOFEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 299,677 L.L
M01AB05 DICLOCELL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 945,809 L.L
M01AB05 DICLO-DENK 75 INJECTION G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 716,268 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 337,880 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 3,801,155 L.L
M01AB05 VOLDEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 422,351 L.L
M01AB05 VOTREX G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 345,368 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 75mg 75mg Capsule, sustained release 732,394 L.L
N06AX16 DEFAXINE G Venlafaxine (HCl) - 75mg 75mg Capsule, extended release 724,395 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 75mg 75mg Capsule, prolonged release 564,414 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 75mg 75mg Capsule, prolonged release 564,414 L.L
N06AX16 VENLAFAXINE ARROW GENERIQUES LP G Venlafaxine - 75mg 75mg Tablet, prolonged release 1,075,074 L.L
N06AX16 VENLAFAXINE BIOGARAN LP G Venlafaxine HCl - 75mg 75mg Capsule, prolonged release 584,571 L.L
N06AX16 VENLAX XR 75 G Venlafaxine HCl - 75mg 75mg Capsule, extended release 895,895 L.L
N06AX16 VENLAX XR 75 G Venlafaxine HCl - 75mg 75mg Capsule, extended release 1,343,843 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 75mg 75mg Injectable solution 194,911,251 L.L
B03XA06 REBLOZYL BioTech Luspatercept - 75mg 75mg Injectable powder for solution 377,881,318 L.L
N07CA02 CINARIN G Cinnarizine - 75mg 75mg Capsule 490,183 L.L
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