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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
N02AX02 TRAMAL B Tramadol HCl - 50mg 50mg Capsule 349,399 L.L
N02AX02 TRAMAL 100MG B Tramadol HCl - 100mg/2ml 100mg/2ml Injectable solution 243,235 L.L
C02KX01 TRACLEER B Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 79,583,961 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 100mg 100mg Tablet, modified release 236,516 L.L
C02KX01 TRACLEER B Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 79,583,961 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 150mg 150mg Tablet, modified release 356,118 L.L
H01AB01 THYROGEN BioHuman Thyrotropin alfa - 0.9mg 0.9mg Injectable lyophilised powder for solution+diluent 65,558,997 L.L
J06BB02 TETAGAM P BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 2,958,325 L.L
J06BB02 TETANUS GAMMA BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 3,077,399 L.L
L04AA04 THYMOGLOBULINE 5mg/ml BioTech Rabbit anti-human thymocyte immunoglobulin - 25mg/5ml 25mg/5ml Injectable powder for solution 21,092,764 L.L
L04AA23 TYSABRI BioTech Natalizumab - 300mg/15ml 300mg/15ml Injectable concentrated solution 126,830,594 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 0.75mg/0.5ml 0.75mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 1.5mg/0.5ml 1.5mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 3mg/0.5ml 3mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 4.5mg 4.5mg/0.5ml Injectable solution 10,165,201 L.L
L01FA01 TRUXIMA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 31,060,158 L.L
L01FA01 TRUXIMA BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 69,144,591 L.L
L01FD01 TRASTUREL BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder 52,047,114 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 440mg 440mg Injectable powder for solution+solvent 75,295,202 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 150mg 150mg Injectable powder for solution 28,550,630 L.L
L04AC13 TALTZ BioTech Ixekizumab - 80mg/ml 80mg/ml Injectable solution 85,080,792 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution 375,054,619 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution 375,054,619 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1875mg/15ml 1875mg/15ml Injectable solution 375,054,619 L.L
A10AE04 TOUJEO BioTech Insulin glargine - 300Units/ml 300Units/ml Injectable solution 4,559,658 L.L
A10AE06 TRESIBA BioTech Insulin degludec - 100IU/ml 100IU/ml Injectable solution 6,857,628 L.L
B06AC05 TAKHZYRO BioTech Lanadelumab - 300mg/2ml Injectable solution 1,204,227,927 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution L.L
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