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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
B05CX01 DEXTROSE G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 195,361 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 224,565 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 185,340 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
B05CX01 DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 158,587 L.L
B05CX01 DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 193,062 L.L
B05CX01 DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 158,587 L.L
B05CX01 DEXTROSE INJECTION 5% G Dextrose, H2O - 5g/100ml Injectable solution 212,797 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 158,587 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 171,228 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 14,833,767 L.L
N05AF05 CLOPIXOL DEPOT B Zuclopenthixol decanoate - 200mg/ml 200mg/ml Injectable solution 512,004 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 2.5mg/dose 2.5mg/dose Injectable solution 39,601,065 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 193,062 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
N05AF05 CLOPIXOL ACUPHASE B Zuclopenthixol acetate - 100mg/2ml 100mg/2ml Injectable solution 857,372 L.L
A02BC01 OMEPRAZOLE-ORBUCELL G Omeprazole (sodium) - 40mg 40mg Injectable solution 3,839,550 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 5mg/dose 5mg/dose Injectable solution 39,601,065 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 186,167 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 7.5mg/dose 7.5mg/dose Injectable solution 39,601,065 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 186,167 L.L
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