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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 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
L04AB06 SIMPONI BioTech Golimumab - 100mg/1ml 100mg/1ml Injectable solution 72,719,241 L.L
L04AC05 STELARA BioTech Ustekinumab - 45mg 45mg Injectable solution 151,777,679 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution 151,777,679 L.L
M03AC11 SISACURE G Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 1,408,347 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 4.2g/100ml 4.2g/100ml Injectable solution 742,370 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 75mg 75mg Injectable solution 194,911,251 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 150mg 150mg Injectable solution 194,911,251 L.L
H01CB02 SANDOSTATIN B Octreotide - 0.1mg/ml 0.1mg/ml Injectable solution 1,038,790 L.L
J02AC01 STABILANOL G Fluconazole - 2mg/ml 2mg/ml Injectable solution 1,242,583 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 90mg 90mg Injectable solution 48,383,450 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 120mg 120mg Injectable solution 57,492,826 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.3mg/ml 0.3mg/ml Injectable solution 168,719,438 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.6mg/ml 0.6mg/ml Injectable solution 180,355,261 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.9mg/ml 0.9mg/ml Injectable solution 183,846,008 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 156,288 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 165,482 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 176,974 L.L
B05XA03 SERUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 163,184 L.L
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