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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
L01EK01 INLYTA B Axitinib - 1mg 1mg Tablet, film coated 57,595,789 L.L
L01EK01 INLYTA B Axitinib - 5mg 5mg Tablet, film coated 184,486,511 L.L
L04AX01 IMURAN B Azathioprine - 50mg 50mg Tablet 2,030,546 L.L
A07FA51 INFLORAN B Bifidobacterium infantis - 1milliard, Lactobacillus acidophilus - 1milliard Capsule 647,732 L.L
R07AA INFASURF B Calfactant - 105mg/3ml 35mg/ml Injectable suspension 23,344,161 L.L
R07AA INFASURF B Calfactant - 210mg/6ml 35mg/ml Injectable suspension 40,596,749 L.L
J07CA09 INFANRIX HEXA B Diphteria toxoid purified (Prefilled syringe) - ?30IU/0.5ml, Tetanus toxoid purified (prefilled syringe) - ?40IU/0.5ml, Bordetella pertussis antigen (Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg+pertactin 8mcg/0.5ml, Poliomyelitis virus type 1 antigen (prefilled syringe) - 40D.U./0.5ml, Poliomyelitis virus type 2 antigen(prefilled syringe) - 8D.U./0.5ml, Poliomyelitis virus type 3 antigen (prefilled syringe) - 32D.U./0.5ml, HBs Antigen (prefilled syringe) - 10mcg/0.5ml, H. Influenza type b polysaccharide (Vial) - 10mcg/0.5ml Injectable suspension 4,230,416 L.L
R05CA12 IVYMUC G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
R05CA12 IVY-CALM G Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Syrup 251,299 L.L
L01FF03 IMFINZI BioTech Durvalumab - 120mg/2.4ml 120mg/2.4ml Injectable solution 59,776,110 L.L
L01FF03 IMFINZI BioTech Durvalumab - 120mg/2.4ml 120mg/2.4ml Injectable solution 59,776,110 L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution 227,939,689 L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution 227,939,689 L.L
G01AF05 IFENEC G Econazole nitrate - 150mg 150mg Ovule 546,944 L.L
J01DH03 INVANZ B Ertapenem - 1g 1g Injectable concentrated powder for solution 3,785,604 L.L
N05CF04 INDUCTAL G Eszopiclone - 2mg 2mg Tablet, film coated 1,411,035 L.L
N05CF04 INDUCTAL G Eszopiclone - 3mg 3mg Tablet, film coated 1,693,242 L.L
G03AC08 IMPLANON NXT B Etonogestrel - 68mg 68mg Implant 12,299,971 L.L
S01BA15 ILUVIEN B Fluocinolone acetonide - 0.19mg 0.19mg Implant 629,182,630 L.L
R03AK08 INUVER B Formoterol fumarate - 6mcg/dose, Beclometasone dipropionate - 100mcg/dose Inhalation solution 3,493,991 L.L
R03AK08 INUVER NEXTHALER B Formoterol fumarate dihydrate - 6mcg/dose, Beclometasone dipropionate - 100mcg/dose Inhalation powder 4,380,927 L.L
L01EB01 IRESSA B Gefitinib - 250mg 250mg Tablet, fim coated 135,027,509 L.L
J07BB02 INFLUVAC B Grippal virus surface antigen 3strains - 15mcgx3strains/0.5ml Injectable suspension 573,821 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 100UI/ml 100UI/ml Injectable solution 6,853,730 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 500UI/5ml 500UI/5ml Injectable solution 26,599,935 L.L
J06BB01 IMMUNORHO BioHuman Human anti-D (rh) immunoglobulin - 300mcg 300mcg Injectable dry powder+diluent 5,794,649 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 10g/200ml 10g/200ml Injectable solution 53,767,929 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 1g/20ml 1g/20ml Injectable solution 7,474,948 L.L
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