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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
L01FA01 RIXATHON BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 111,983,163 L.L
L04AB02 REMSIMA SC BioTech Infliximab - 120mg/ml 120mg/ml Injectable solution 52,597,003 L.L
L01FA01 RUXIENCE BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 59,148,151 L.L
A10AD06 RYZODEG BioTech Insulin degludec - 70%, Insulin aspart - 30% 100IU/ml Injectable solution 7,058,661 L.L
C10AX13 REPATHA BioTech Evolocumab - 140mg/1ml Injectable solution 44,151,793 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
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution 79,337,698 L.L
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution 15,147,973 L.L
L01FA01 RITUXIREL BioTech Rituximab - 100mg 100mg/10ml Injectable concentrated solution L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg 500mg/10ml Injectable concentrated solution L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 2.5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
B01AF01 RIBAVAN G Rivaroxaban - 20mg 20mg Tablet, film coated 1,343,843 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
R06AX27 RINA 5 G Desloratadine - 5mg 0.5mg/ml Tablet, film coated 134,384 L.L
B01AF01 RIXALTA 20 G Rivaroxaban - 20mg 20mg Tablet, film coated 1,164,664 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 10mg Capsule, hard 1,358,625 L.L
L03AX16 REVIXIL 20 G Plerixafor - 20mg/ml 20mg/ml Injectable solution 248,280,900 L.L
B01AF01 RIBAVAN G Rivaroxaban - 10mg 10mg Tablet, film coated 959,888 L.L
B01AF01 RIXALTA 10 G Rivaroxaban - 10mg 10mg Tablet, film coated 671,921 L.L
G04BE08 RAVANA G Tadalafil - 20mg 20mg Tablet 500,421 L.L
R06AX27 RINA G Desloratadine - 0.5mg/ml 0.5mg/ml Syrup 159,917 L.L
C03BA11 RAWEL SR G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 362,837 L.L
R06AX28 RUPATADINE BIOGARAN G Rupatadine - 10mg 10mg Tablet 341,336 L.L
M01AE51 RELI-FLU G Ibuprofen - 200mg, Pseudoephedrine HCl - 30mg Tablet, film coated 139,504 L.L
G04BE08 RAVANA G Tadalafil - 5mg 5mg Tablet 1,501,264 L.L
J01DB05 ROXIL G Cefadroxil (monohydrate) - 250mg/5ml 250mg/5ml Powder for suspension 459,594 L.L
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