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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
D10AD01 KETREL G Tretinoin - 0.05% 0.05% Cream 397,777 L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 160mg 160mg Injectable powder for concentrate for solution L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 160mg 160mg Injectable powder for concentrate for solution 216,872,714 L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 100mg 100mg Injectable powder for concentrate for solution L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 100mg 100mg Injectable powder for concentrate for solution 135,545,977 L.L
L01FD01 KANJINTI BioTech Trastuzumab - 420mg 420mg Injectable powder for concentrate for solution 79,305,881 L.L
B01AC24 KLOTEGO G Ticagrelor - 90mg 90mg Tablet, film coated 2,598,096 L.L
B01AC24 KLOTEGO G Ticagrelor - 90mg 90mg Tablet, film coated 2,598,096 L.L
B01AC24 KLOTEGO G Ticagrelor - 60mg 60mg Tablet, film coated 2,598,096 L.L
B01AC24 KLOTEGO G Ticagrelor - 60mg 60mg Tablet, film coated 2,598,096 L.L
A10BD10 KOMBIGLYZE XR B Saxagliptin HCl - 5mg, Metformin HCl - 1000mg Tablet, extended release 3,979,118 L.L
A10BD10 KOMBIGLYZE XR B Saxagliptin HCl - 2.5mg, Metformin HCl - 1000mg Tablet, extended release 4,059,748 L.L
L01EF02 KISQALI B Ribociclib - 200mg 200mg Tablet, film coated 200,752,977 L.L
J01MA17 KINODROX B Prulifloxacin - 600mg 600mg Tablet, film coated 1,407,835 L.L
B02BA01 KONAKION MM PEDIATRIC B Phytomenadione - 2mg/0.2ml 2mg/0.2ml Solution 442,124 L.L
L01FF02 KEYTRUDA BioTech Pembrolizumab - 100mg/4ml 100mg/4ml Injectable solution L.L
L01FF02 KEYTRUDA BioTech Pembrolizumab - 100mg/4ml 100mg/4ml Injectable solution 241,744,802 L.L
N02BE01 KIDOL-OR G Paracetamol - 240mg/5ml 240mg/5ml Elixir 314,843 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
D07AC13 KONEX G Mometasone furoate - 0.1% 0.1% Solution 385,683 L.L
J05AR10 KALUVIA G Lopinavir - 200mg, Ritonavir - 50mg Tablet, film coated 7,632,790 L.L
N03AX14 KEPAM MS G Levetiracetam - 500mg/5ml 500mg/5ml Injectable solution 9,170,015 L.L
N03AX14 KEPPRA B Levetiracetam - 500mg 500mg Tablet, film coated 6,478,288 L.L
N03AX14 KEPCITAM G Levetiracetam - 500mg 500mg Tablet, film coated 2,933,608 L.L
N03AX14 KEPPRA B Levetiracetam - 250mg 250mg Tablet, film coated 3,240,855 L.L
N03AX14 KEPPRA B Levetiracetam - 1000mg 1,000mg Tablet, film coated 12,202,941 L.L
N03AX14 KEPCITAM G Levetiracetam - 1000mg 1000mg Tablet, film coated 3,119,058 L.L
M01AB15 KETO-AVI G Ketorolac tromethamine - 30mg/ml 30mg/ml Injectable solution 106,164 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 30mg/2ml 30mg/2ml Injectable solution 106,164 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 10mg 10mg Tablet 106,164 L.L
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