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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
N05AX08 RISPERDAL B Risperidone - 1mg 1mg Tablet, film coated 323,866 L.L
N05AX08 RISPERDAL B Risperidone - 1mg 1mg Tablet, film coated 323,866 L.L
J06BB01 RHOPHYLAC 300 BioHuman Human anti-D (rh) immunoglobulin - 300mcg/2ml 300mcg/2ml Injectable solution 5,939,784 L.L
J06BB01 RHESONATIV BioHuman Human anti-D (rh) immunoglobulin - 625IU/ml 625IU/ml Injectable solution 12,281,758 L.L
J06BB05 RABISHIELD-100 (RABIES HUMAN MONOCLONAL ANTIBODY rDNA) BioHuman Rabies, Human IgG1 Monoclonal Antibody - 100IU/2.5ml 100IU/2.5ml 8,455,824 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 149,006,584 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 2000IU 2000IU Injectable powder for solution+solvent 298,171,597 L.L
B02BD08 RECOFACT VII BioTech Eptacog alfa (activated) recombinant - 1.2mg 1.2mg Injectable powder for solution+diluent 47,533,131 L.L
J07BG01 RABIVAX-S (RABIES VACCINE INACTIVATED) BioTech Freeze dried inactivated purified rabies antigen (Pitman Moore PM3218 as virus strain) - Injectable freeze dried material 1,552,138 L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution 82,479,505 L.L
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution 15,147,973 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL FREEZE-DRIED) BioTech Rotavirus bovine-human , live attenuated - Suspension 2,822,069 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL LIQUID) BioTech Rotavirus bovine-human , live attenuated - Liquid 2,822,069 L.L
A10AD06 RYZODEG BioTech Insulin degludec - 70%, Insulin aspart - 30% 100IU/ml Injectable solution 7,058,661 L.L
L03AB07 RECIGEN 44 BioTech Interferon beta-1a - 44mcg/0.5ml 44mcg/0.5ml Injectable solution 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
L01FA01 RITUXIREL BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution 11,708,063 L.L
L01FA01 RIXATHON BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 28,438,096 L.L
L01FA01 RUXIENCE BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 13,157,756 L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrated solution 45,258,360 L.L
L01FA01 RIXATHON BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 66,951,899 L.L
L01FA01 RIXATHON BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 116,417,745 L.L
L01FA01 RUXIENCE BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 59,148,151 L.L
L01FA01 RITUXIREL BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrated solution L.L
L01FA01 RITUXIREL BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrated solution L.L
L03AB07 REBIF BioTech Interferon beta-1a - 44mcg/0.5ml 12MIU Injectable solution L.L
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    ...
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