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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
B03AC FERINJECT B Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable solution 10,212,033 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 7,582,922 L.L
L01BB05 FLUDARABIN EBEWE G Fludarabine Dihydrogenophosphate - 50mg/2ml 50mg/2ml Injectable solution 3,567,902 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 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
H01AC01 OMNITROPE BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 26,295,375 L.L
L01BB05 FLUDARABINE PHOSPHATE NEAPOLIS G Fludarabine Dihydrogenophosphate - 50mg/2ml 50mg/2ml Injectable solution 4,031,528 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
H01AC01 CINNATROPIN BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 9,012,607 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 75mg 75mg Injectable solution 194,911,251 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 14,532,052 L.L
J01XX08 ZYVOX IV B Linezolide - 600mg/300ml 600mg/300ml Injectable solution 4,414,523 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 150mg 150mg Injectable solution 194,911,251 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 145,946 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 45,388,478 L.L
J01XX08 LINEDOR G Linezolide - 600mg/300ml 600mg/300ml Injectable solution 2,045,328 L.L
L01BC01 ALEXAN G Cytarabine - 100mg/5ml 100mg/5ml Injectable solution 388,370 L.L
L01FE01 ERBITUX BioTech Cetuximab - 100mg/20ml 100mg/20ml Injectable solution 24,001,769 L.L
L04AC19 ENSPRYNG BioTech Satralizumab - 120mg/ml 120mg/ml Injectable solution 857,061,795 L.L
A10AB06 APIDRA SOLOSTAR BioTech Insulin glulisine - 100IU/ml 100IU/ml Injectable solution 3,942,834 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 151,692 L.L
J01XX08 LINEZOLID ARROW G Linezolide - 600mg/300ml 2mg/ml Injectable solution 13,282,147 L.L
L01BC01 ALEXAN G Cytarabine - 1,000mg/20ml 1,000mg/20ml Injectable solution 2,848,946 L.L
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