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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
A02BC04 RAMEP G Rabeprazole (sodium) - 20mg 20mg Tablet, gastroresistant 499,046 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 20mg 20mg Tablet, gastroresistant 1,005,194 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 20mg 20mg Tablet, gastroresistant 1,005,194 L.L
A02BC05 ESOMEP G Esomeprazole - 20mg 20mg Tablet, gastroresistant 415,632 L.L
A02BC05 ESOMEP G Esomeprazole - 40mg 40mg Tablet, gastroresistant 474,598 L.L
A02BC05 METAPRO G Esomeprazole - 40mg 40mg Tablet, gastroresistant 639,669 L.L
N07BB03 ACAMPROSATE BIOGARAN G Acamprosate - 333mg 333mg Tablet, gastroresistant 3,641,813 L.L
J02AC04 NOXAFIL B Posaconazole - 100mg 100mg Tablet, gastroresistant 62,027,714 L.L
A16AX BICANORM G Sodium bicarbonate - 1000mg 1000mg Tablet, gastroresistant 2,623,181 L.L
M01AB05 OLFEN-50 G Diclofenac sodium - 50mg 50mg Tablet, gastroresistant 248,611 L.L
V01AA ACARIZAX 12 SQ-HDM ORAL LYOPHILISATE B Allergen extracts - 12 SQ-HDM Tablet, lyophilised 9,366,451 L.L
J01AA02 TOLEXINE G Doxycycline (monohydrate) - 100mg 100mg Tablet, microgranules 589,947 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 200mg 200mg Tablet, modified release 474,376 L.L
A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 8,454,523 L.L
G04CA01 PROSTETROL G Alfuzosin HCl - 10mg 10mg Tablet, modified release 360,150 L.L
A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 12,310,378 L.L
G04CA01 PROSTETROL G Alfuzosin HCl - 10mg 10mg Tablet, modified release 682,672 L.L
G04CA53 VESOMNI B Tamsulosin HCl - 0.4mg, Solifenacin succinate - 6mg Tablet, modified release 4,491,122 L.L
A10BB09 DIAMICRON MR B Gliclazide - 60mg 60mg Tablet, modified release 382,995 L.L
C08DA51 TARKA B Verapamil - 240mg, Trandolapril - 4mg Tablet, modified release 3,797,532 L.L
J01FA09 KLACID RM B Clarithromycin - 500mg 500mg Tablet, modified release 1,173,175 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 100mg 100mg Tablet, modified release 236,516 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 150mg 150mg Tablet, modified release 356,118 L.L
N05AH03 OLANZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,316,966 L.L
N05AH03 OLIZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,466,580 L.L
N05AH03 OLANZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,329,327 L.L
N05AH03 OLIZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,598,096 L.L
R03DC03 ROMILAST G Montelukast (sodium) - 5mg 5mg Tablet, mouth dissolving 518,723 L.L
R03DC03 ROMILAST G Montelukast (sodium) - 4mg 4mg Tablet, mouth dissolving 405,840 L.L
H01BA02 MINIRIN MELT B Desmopressin - 120mcg 120mcg Tablet, Oral lyophilisate 4,970,873 L.L
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