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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
C10AA07 ROXARDIO G Rosuvastatin (calcium) - 40mg 40mg Tablet, film coated 720,525 L.L
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution L.L
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution 15,147,973 L.L
C10AC01 RESINCOLESTIRAMINA G Cholestyramine - 4g 4g Powder for suspension 2,998,113 L.L
R03DC03 RELIEFAST G Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,034,119 L.L
R03DC03 ROMILAST G Montelukast (sodium) - 4mg 4mg Tablet, mouth dissolving 405,840 L.L
N05AX08 RISPERDAL B Risperidone - 4mg 4mg Tablet, film coated 498,566 L.L
N05AX08 RISPERDAL B Risperidone - 4mg 4mg Tablet, film coated 498,566 L.L
N05AX08 RESPAL 4 G Risperidone - 4mg 4mg Caplet, film coated 557,695 L.L
N05AX08 RISPERIDONE BIOGARAN G Risperidone - 4mg 4mg Tablet, coated, scored 1,105,982 L.L
N05AX08 RISCHOTIC OD 4 G Risperidone - 4mg 4mg Tablet, orally disintegrating 605,369 L.L
N05AX16 REXULTI B Brexpiprazole - 4mg 4mg Tablet, film coated 13,433,051 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
J01DB05 ROXIL G Cefadroxil (monohydrate) - 500mg 500mg Capsule 869,466 L.L
P01AB01 RAMAZOL G Metronidazole - 500mg 500mg Tablet 216,359 L.L
J01FA09 RITHROCID G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg 500mg/10ml Injectable concentrated solution L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg 500mg/50ml Injectable concentrated solution 45,258,360 L.L
L01FA01 RIXATHON BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 64,401,569 L.L
L01FA01 RIXATHON BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 111,983,163 L.L
L01FA01 RUXIENCE BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 59,148,151 L.L
R01AD08 RINISONA G Fluticasone propionate - 50mcg/actuation 50mcg/dose Spray, suspension 556,351 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated 69,643,660 L.L
M02AA31 ROXONIN TAPE B Loxoprofen Sodium Hydrate - 50mg 50mg Patch 710,893 L.L
N05AH04 REZAL XR G Quetiapine fumarate - 50mg 50mg Tablet, extended release 533,505 L.L
N07XX02 RILUTEK B Riluzole - 50mg 50mg Tablet, film coated 15,886,212 L.L
N07XX02 RILUTEK B Riluzole - 50mg 50mg Tablet, film coated 15,886,212 L.L
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