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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
A10AB06 APIDRA BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 2,221,372 L.L
B05XA01 CHLORURE DE POTASSIUM RENAUDIN G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 360,150 L.L
L04AB01 ETANERREL BioTech Etanercept - 50mg/ml 50mg/ml Injectable solution 9,756,719 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 3,023,493 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 15g/100ml 15g/100ml Injectable solution 5,688,441 L.L
L01BA01 METHOTREXAT EBEWE G Methotrexate - 500mg 500mg Injectable solution 1,842,408 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
L01BA01 EBETREXAT G Methotrexate - 50mg/5ml 50mg/5ml Injectable solution 1,507,821 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 4.2g/100ml 4.2g/100ml Injectable solution 742,370 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 91,457,321 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 179,063,666 L.L
N02BE01 PARACETAMOL PANPHARMA G Paracetamol - 10mg/ml 10mg/ml Injectable solution 1,959,322 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 52,597,003 L.L
N02BE01 MAKOACHE G Paracetamol - 1000mg/100ml 10mg/ml Injectable solution 1,403,867 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 145,946 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 179,063,666 L.L
N02BE01 PARACETAMOL S.A.L.F G Paracetamol - 1000mg/100ml 10mg/ml Injectable solution 5,542,006 L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 151,692 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 200mg 200mg Injectable solution 123,001,362 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 91,457,321 L.L
N02BE01 STOPALGIC G Paracetamol - 1g/100ml 1g/100ml Injectable solution 1,536,012 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 164,333 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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