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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
A10BD15 DIAFLOZIN PLUS G Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet, film coated 2,483,421 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 20mg 20mg Tablet, film coated 103,165,573 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 75mg 75mg Capsule, hard 2,576,338 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 9,340,433 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 254,729,810 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 50mg, Pridinol mesylate - 4mg Tablet, film coated 575,165 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 140mg 140mg Tablet, film coated 127,364,905 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 75mg, Pridinol mesylate - 2.2mg Injectable solution 1,131,515 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 400mcg/4ml 400mcg/4ml Injectable concentrate for solution 15,543,897 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 2,576,338 L.L
M01AB55 DIFEN PLUS G Diclofenac potassium - 50mg, Betamethasone - 0.3mg Tablet, coated 503,941 L.L
N06AA01 DESIPRAMINE G Desipramine (HCl) - 50mg 50mg Tablet, scored 656,563 L.L
M01AB55 DIFEN B12 G Diclofenac potassium - 50mg, Betamethasone - 0.3mg, Cyanocobalamin - 5mg Tablet 503,941 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Metered dose spray 147,823 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 2,576,338 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,104,639 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Drops 145,135 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 620,855 L.L
N01BB52 DILOCAIN 2% G Lidocaine HCl - 20mg/1.7ml, Epinephrine (bitartrate) - 0.0125mg/1.7ml Injectable solution 2,768,316 L.L
M01AB55 DIFEN B12 G Diclofenac sodium - 75mg, Prednisolone sodium phosphate - 10.08mg, Hydroxocobalamin acetate - 10.44mg Injectable solution 978,317 L.L
N06AA12 DOXEPIN HCl G Doxepin (HCl) - 10mg 10mg Capsule 712,876 L.L
N06AA12 DOXEPIN HCl G Doxepin (HCl) - 50mg 50mg Capsule 965,007 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.05% 0.05% Metered dose spray 155,886 L.L
L01FC01 DARZALEX BioTech Daratumumab - 400mg/20ml 400mg/20ml Injectable concentrate for solution L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 200mg 200mg Injectable solution 123,001,362 L.L
L01FC01 DARZALEX BioTech Daratumumab - 400mg/20ml 400mg/20ml Injectable concentrate for solution 164,970,376 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 200mg 200mg Injectable solution 123,001,362 L.L
L01FC01 DARZALEX BioTech Daratumumab - 1800mg 1800mg Injectable solution 494,909,963 L.L
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