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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
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 830,623 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 7,236,698 L.L
B02BD01 OCTAPLEX BioHuman Prothrombin complex, human (PPSB) - 500IU 500IU Injectable powder for solution+diluent 37,682,862 L.L
B02BD02 NOVOEIGHT BioTech Turoctocog Alfa - 500IU 500IU Injectable powder for solution+diluent 29,783,973 L.L
B02BD02 NUWIQ BioTech Coagulation Factor VIII recombinant, human (Simoctogog alfa) - 500IU 500IU Injectable powder for solution+diluent 45,612,427 L.L
B02BD02 RECOFACT VIII BioTech Moroctocog alfa - 500IU 500IU Injectable powder for solution+diluent 12,049,005 L.L
B02BD02 ESPEROCT BioTech Turoctocog Alfa pegol (recombinant coagulation factor VIII) - 500IU/Vial 500IU/Vial Injectable powder for solution+diluent 38,126,657 L.L
B02BD02 ESPEROCT BioTech Turoctocog Alfa pegol (recombinant coagulation factor VIII) - 1000IU/Vial 1000IU/Vial Injectable powder for solution+diluent 72,849,268 L.L
A02BC01 OMEPRAZOLE VIANEX G Omeprazole (sodium) - 40mg 40mg Injectable powder for solution+diluent 467,657 L.L
B02BD04 BENEFIX BioTech Nonacog alfa (recombinant coagulation factor IX) - 500IU 500IU Injectable powder for solution+diluent 27,390,281 L.L
B02BD06 WILATE 500 BioHuman Von Willebrand Factor - 500IU, Blood Coagulation Factor VIII - 500IU Injectable powder for solution+diluent 32,399,164 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 2mg 2mg (100KIU) Injectable powder for solution+diluent 105,957,406 L.L
B02BD08 ARYOSEVEN RT BioTech Eptacog alfa - 1mg 1mg Injectable powder for solution+diluent 16,902,713 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent 57,890,287 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 5mg 5mg (250KIU) Injectable powder for solution+diluent 264,894,762 L.L
B02BD08 RECOFACT VII BioTech Eptacog alfa (activated) recombinant - 1.2mg 1.2mg Injectable powder for solution+diluent 47,533,131 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g, Lidocaine (ampoule) - 0.5g Injectable powder for solution+diluent 511,940 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g 0.5g Injectable powder for solution+diluent 511,940 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g 0.5g Injectable powder for solution+diluent 433,869 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g, Lidocaine (ampoule) - 0.5g Injectable powder for solution+diluent 403,153 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g, Lidocaine (ampoule) - 0.5g Injectable powder for solution+diluent 403,153 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g 0.5g Injectable powder for solution+diluent 511,940 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g 0.5g Injectable powder for solution+diluent 511,940 L.L
J01DD04 MEDAXONUM G Ceftriaxone (disodium) (Vial) - 500mg, Lidocaine (ampoule) - 500mg Injectable powder for solution+diluent 307,740 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 500mg 500mg Injectable powder for solution+diluent 356,118 L.L
J01DD04 AXONE 1G IM G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution+diluent 438,093 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution+diluent 643,765 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 1g, Lidocaine (ampoule) - 1g Injectable powder for solution+diluent 568,253 L.L
H01AC01 GENOTROPIN BioTech Somatropin recombinant - 5.3mg/1.15ml 5.3mg/1.15ml Injectable powder for solution+diluent 4,724,854 L.L
    ...
    129
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