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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
H02AB09 SOLU CORTEF ACT-O-VIAL B Hydrocortisone (sodium succinate) - 250mg 250mg Injectable lyophilised powder for solution+diluent 421,967 L.L
M01AC02 SORAL G Tenoxicam - 20mg/2ml 20mg/2ml Injectable lyophilised powder for solution+solvent 588,603 L.L
J01DH51 SYNERGIC G Imipenem - 500mg, Cilastatin - 500mg Injectable powder 1,142,266 L.L
L04AC02 SIMULECT BioTech Basiliximab - 20mg 20mg Injectable powder + solvent 131,822,828 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
A02BC05 SOLEZOL G Esomeprazole - 40mg 40mg Injectable powder for solution 301,021 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 500mg 500mg Injectable powder for solution 718,956 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 1g 1g Injectable powder for solution 1,444,631 L.L
J01DE01 SALAPIME G Cefepime - 1g 1g Injectable powder for solution 618,168 L.L
H02AB04 SOLU MEDROL Act-O-Vial B Methylprednisolone sodium succinate - 40mg 40mg Injectable powder for solution+diluent 313,115 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent 36,504,302 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent 54,757,132 L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 158,587 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 193,062 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 186,167 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 186,167 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 205,703 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 221,792 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 268,908 L.L
N02BE01 STOPALGIC G Paracetamol - 1g/100ml 1g/100ml Injectable solution 1,536,012 L.L
N02BE01 SOLUFLEX PARACETAMOL G Paracetamol - 1g/100ml 1g/100ml Injectable solution 211,175 L.L
N02BE01 SUPOFEN G Paracetamol - 10mg/ml 10mg/ml Injectable solution 7,675,286 L.L
N06BX06 SOMAZINA B Citicoline (sodium) - 1,000mg/4ml 1,000mg/4ml Injectable solution 787,492 L.L
L04AB06 SIMPONI BioTech Golimumab - 50mg/0.5ml 50mg/0.5ml Injectable solution 72,719,241 L.L
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