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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
L02AE04 DECAPEPTYL SR B Triptorelin (pamoate) - 11.25mg 11.25mg Injectable powder for suspension+diluent 31,761,098 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 2,576,338 L.L
M01AB05 DICLOGESIC 12.5 CHILDREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 83,318 L.L
M01AX DORIXINA B Lysine clonixinate - 125mg 125mg Tablet 326,554 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 254,729,810 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 127,364,905 L.L
L01EL01 DULLARMA G Ibrutinib - 140mg 140mg Capsule, hard 422,860,803 L.L
L01EL01 DULLARMA G Ibrutinib - 140mg 140mg Capsule, hard L.L
M01AX05 DONA G Glucosamine hemisulfate - 1500mg 1500mg Powder for solution 1,615,299 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 2,576,338 L.L
J01FF01 DALACIN-C B Clindamycin HCl - 150mg 150mg Capsule 287,582 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
N06AX16 DEPREVIX HELLAS G Venlafaxine - 150mg 150mg Capsule, prolonged release 968,910 L.L
J02AC01 DIFLUCAN B Fluconazole - 150mg 150mg Capsule 286,238 L.L
A11CC06 DEDROGYL G Calcifediol - 15mg/100ml 15mg/100ml Drops solution 827,807 L.L
C09CA03 DIOVAN B Valsartan - 160mg 160mg Tablet, film coated 846,621 L.L
L01FC01 DARZALEX BioTech Daratumumab - 1800mg 1800mg Injectable solution 514,508,612 L.L
V03AC03 DEFERASIROX ARROW G Deferasirox - 180mg 180mg Tablet, coated 9,056,837 L.L
V03AC03 DEFEROXAL 180 G Deferasirox - 180mg 180mg Tablet, film coated 13,424,141 L.L
A10BA02 DIAPHAGE G Metformin HCl - 1g 1g Tablet, extended release 150,510 L.L
A11CC03 DERIL G Alfacalcidol - 1mcg 1mcg Capsule, soft 783,460 L.L
A10BB12 DIAMERIL G Glimepiride - 1mg 1mg Tablet 130,545 L.L
N05AX08 DEPIA ORAL SOLUTION G Risperidone - 1mg/ml 1mg/ml Solution 1,510,223 L.L
S01BA01 DEXAFREE G Dexamethasone Phosphate - 1mg/ml 1mg/ml Drops solution 563,070 L.L
S01BA01 DEXAFREE G Dexamethasone Phosphate - 1mg/ml 1mg/ml Drops solution 563,070 L.L
C05AE03 DILTIGEL G Diltiazem HCl - 2% 2% Gel 632,950 L.L
D01AC14 DERMOFIX B Sertaconazole nitrate - 20mg/g 2% Cream 382,995 L.L
M02AA15 DILO G Diclofenac sodium - 2% 2% Gel 267,489 L.L
D06AX01 DERMOFUCIN G Fusidic acid - 2% 2% Cream 290,270 L.L
B05CX01 DEXTROSE 20% INJECTION USP G Glucose - 20% 20% Injectable solution 316,025 L.L
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