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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
A04AA02 KYTRIL B Granisetron (HCl) - 1mg 1mg Tablet, film coated 2,765,628 L.L
A04AA02 KYTRIL B Granisetron (HCl) - 3mg/3ml 3mg/3ml Injectable solution 3,711,693 L.L
A10BD10 KOMBIGLYZE XR B Saxagliptin HCl - 2.5mg, Metformin HCl - 1000mg Tablet, extended release 4,059,748 L.L
A10BD10 KOMBIGLYZE XR B Saxagliptin HCl - 5mg, Metformin HCl - 1000mg Tablet, extended release 3,979,118 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
B02BA01 KONAKION MM PEDIATRIC B Phytomenadione - 2mg/0.2ml 2mg/0.2ml Solution 442,124 L.L
C07AB05 KERLONE B Betaxolol HCl - 20mg 20mg Tablet, film coated, scored 575,165 L.L
D01AC08 KETOCONAZOLE KORHISPANA G Ketoconazole - 2% 2% Gel 599,354 L.L
D07AC13 KONEX G Mometasone furoate - 0.1% 0.1% Solution 385,683 L.L
D10AD01 KETREL G Tretinoin - 0.05% 0.05% Cream 397,777 L.L
J01CR02 KLAVOX G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
J01CR02 KLAVOX G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet, film coated 338,648 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 250mg/5ml 250mg/5ml Granules for suspension 477,384 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 500mg 500mg Capsule 659,123 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Tablet, film coated 1,329,060 L.L
J01FA09 KLERIMED G Clarithromycin - 500mg 500mg Tablet 686,704 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Injectable powder for solution 1,428,505 L.L
J01FA09 KLACID B Clarithromycin - 125mg/5ml 125mg/5ml Granules for suspension 575,165 L.L
J01FA09 KLACID B Clarithromycin - 250mg/5ml 250mg/5ml Granules for suspension 1,698,617 L.L
J01FA09 KLACID RM B Clarithromycin - 500mg 500mg Tablet, modified release 1,173,175 L.L
J01MA17 KINODROX B Prulifloxacin - 600mg 600mg Tablet, film coated 1,407,835 L.L
J05AR10 KALUVIA G Lopinavir - 200mg, Ritonavir - 50mg Tablet, film coated 7,632,790 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution 35,639,835 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 10g/100ml 10g/100ml Injectable solution 54,343,313 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution L.L
L01EF02 KISQALI B Ribociclib - 200mg 200mg Tablet, film coated 200,752,977 L.L
L01FD01 KANJINTI BioTech Trastuzumab - 420mg 420mg Injectable powder for concentrate for solution 79,305,881 L.L
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