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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
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
A10AB06 APIDRA SOLOSTAR BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 3,942,834 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 14,833,767 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
A10AB06 APIDRA BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 2,221,372 L.L
B05XA01 CHLORURE DE POTASSIUM RENAUDIN G Potassium chloride - 7.46g/100ml 7.46% Injectable solution 385,683 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 7.46g/100ml 7.46g/100ml Injectable solution 2,822,386 L.L
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 7.46g/100ml 7.46g/100ml Injectable solution 663,077 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 56,780,638 L.L
B05XA01 CHLORURE DE POTASSIUM RENAUDIN G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 360,150 L.L
L04AB01 ERELZI BioTech Etanercept - 50mg 50mg Injectable solution 39,269,439 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 3,023,493 L.L
L04AB01 ALTEBREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 27,383,989 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 15g/100ml 15g/100ml Injectable solution 5,688,441 L.L
L04AB01 ENBREL BioTech Etanercept - 25mg 25mg Injectable solution 28,768,353 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
L04AB01 ERELZI BioTech Etanercept - 25mg 25mg Injectable solution 24,770,928 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 4.2g/100ml 4.2g/100ml Injectable solution 742,370 L.L
L04AB01 ETANERREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 5,085,100 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
L04AB01 ETANERREL BioTech Etanercept - 50mg/ml 50mg/ml Injectable solution 9,756,719 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
L01BA01 METHOTREXAT EBEWE G Methotrexate - 500mg 500mg Injectable solution 1,842,408 L.L
N05AF05 CLOPIXOL DEPOT B Zuclopenthixol decanoate - 200mg/ml 200mg/ml Injectable solution 512,004 L.L
A10AD06 RYZODEG BioTech Insulin degludec - 70%, Insulin aspart - 30% 100IU/ml Injectable solution 7,058,661 L.L
    ...
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