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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
B01AF01 RIBAVAN G Rivaroxaban - 2.5mg 2.5mg Tablet, film coated 3,199,625 L.L
B01AF01 RIBAVAN G Rivaroxaban - 15mg 15mg Tablet, film coated 1,343,843 L.L
B01AF01 RIXALTA 15 G Rivaroxaban - 15mg 15mg Tablet, film coated 1,164,664 L.L
B02BD02 RECOFACT VIII BioTech Moroctocog alfa - 500IU 500IU Injectable powder for solution+diluent 12,049,005 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 500IU 500IU Injectable powder for solution+solvent 76,080,435 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 1000IU 1000IU Injectable powder for solution+solvent 143,279,414 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 2000IU 2000IU Injectable powder for solution+solvent 286,711,575 L.L
B02BD08 RECOFACT VII BioTech Eptacog alfa (activated) recombinant - 1.2mg 1.2mg Injectable powder for solution+diluent 47,533,131 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 25mg 25mg Tablet, film coated 75,701,015 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated 69,643,660 L.L
B03XA06 REBLOZYL BioTech Luspatarcept - 25mg 25mg Injectable powder for solution 125,960,784 L.L
B03XA06 REBLOZYL BioTech Luspatercept - 75mg 75mg Injectable powder for solution 377,881,318 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 199,957 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 189,615 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 129,934 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 224,565 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 154,450 L.L
B05BB01 R-SOL G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
C01BC03 RYTMONORM B Propafenone HCl - 150mg 150mg Tablet, film coated 1,077,193 L.L
C01BC03 RYTMONORM B Propafenone HCl - 300mg 300mg Tablet, film coated 1,812,100 L.L
C01EB18 RANEXA B Ranolazine - 375mg 375mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
C01EB18 RANEXA B Ranolazine - 750mg 750mg Tablet, prolonged release 3,985,837 L.L
C03BA11 RAWEL SR G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 362,837 L.L
C05AE01 RECTOGESIC G Glyceryl trinitrate - 0.2% w/w 0.2% w/w Ointment 2,553,301 L.L
C05CX REPARIL B Aescine - 20mg 20mg Tablet, sugar coated 510,660 L.L
C09AA02 RENITEC B Enalapril maleate - 20mg 20mg Tablet 405,840 L.L
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