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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
J07BK01 VARICELLA VACCINE LIVE BioTech Varicella-herpes zoster virus (Oka strain), grown in human diploid cells (SV-cell line), live attenuated - Injectable suspension 3,104,276 L.L
J07BM03 GARDASIL 9 HUMAN PAPILLOMAVIRUS 9- VALENT VACCINE RECOMBINANT B Papillomavirus (human type 6) - 30mcg/0.5ml, Papillomavirus (human type 11) - 40mcg/0.5ml, Papillomavirus (human type 16) - 60mcg/0.5ml, Papillomavirus (human type 18) - 40mcg/0.5ml, Papillomavirus (human type 31) - 20mcg/0.5ml, Papillomavirus (human type 33) - 20mcg/0.5ml, Papillomavirus (human type 45) - 20mcg/0.5ml, Papillomavirus (human type 52) - 20mcg/0.5ml, Papillomavirus (human type 58) - 20mcg/0.5ml Injectable suspension 14,139,396 L.L
J07BX05 ABRYSVO B RSV subgroup A stabilized perfusion F antigen 60mcg - 60mcg, RSV subgroup B stabilized perfusion F antigen 60mcg - 60mcg, Glycoprotein F stabilized in the perfusion conformation - Injectable powder + solvent 22,650,721 L.L
J07CA LANTIGEN B B Streptococcus pneumoniae type 3 (antigenic extracts) - 63.2A.U./ml, Streptococcus pyogenes group A (antigenic extracts) - 126.2A.U./ml, Branhamella catarrhalis (antigenic extracts) - 39.9A.U./ml, Staphylococcus aureus (antigenic extracts) - 79.6A.U./ml, Haemophilus influenzae type b (antigenic extracts) - 50.2A.U./ml, Klebsiella pneumoniae (antigenic extracts) - 39.8A.U./ml Drops suspension 916,501 L.L
J07CA02 TETRAXIM (Vaccin Diphterique, tetanique, coquelucheux acellulaire et Poliomyelitique inactivé adsorbé) B Diphteria toxoid purified - ?30IU, Tetanus toxoid purified - ?40IU, Poliomyelitis virus type 1 inactivated - 40D.U., Poliomyelitis virus type 2 inactivated - 8D.U., Poliomyelitis virus type 3 inactivated - 32D.U., Bordetella Pertussis Antigens: toxoid - 25mcg, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg Injectable suspension 1,628,737 L.L
J07CA06 INFANRIX IPV + HIB B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen(Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg+pertactin 8mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 3,014,239 L.L
J07CA06 PENTAXIM B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen (Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 2,558,676 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
J07CA09 HEXAXIM BioTech Diphteria Toxoid - ?20IU/0.5ml, Tetanus toxoid - ?40IU/0.5ml, Bordetella Pertussis Antigens: toxoid - 25mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg/0.5ml, Polio virus inactivated type 1 (Mahoney strain) - 40D antigen units/0.5ml, Polio virus inactivated type 2 (MEF-I strain) - 8D antigen units/0.5ml, Polio virus inactivated type 3 (Saukett strain) - 32D antigen units/0.5ml, Hepatitis B, surface antigen - 10mcg/0.5ml, H. Influenza type b polysaccharide1 ,2 - 12mcg/0.5ml, 1 conjugated to tetanus protein - 22-36mcg, 2 adsorbed on aluminium hydroxide hydrated, Al+++ - 0.6mg Injectable suspension 4,462,901 L.L
J07CA11 DIPHTHERIA, TETANUS,PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE B Diphteria Toxoid1 - ?25Lf (?30IU)/0.5ml, Tetanus toxoid1 - ?2.5Lf (?40IU)/0.5ml, Bordetella pertussis (Whole cell) - ?16OU (?4.0IU)/0.5ml, HBs Antigen (r DNA)1 - ?10mcg/0.5ml, H. Influenza type b, purified capsular polysaccharide2 - 10mcg/0.5ml, 1 adsorbed on aluminium phosphate, Al+++ - ?1.25mg , 2 conjugated to tetanos toxoid carrier protein - Injectable suspension 1,515,854 L.L
L01AA01 ENDOXAN B Cyclophosphamide (monohydrate) - 500mg 500mg Injectable powder for solution 764,646 L.L
L01AA06 HOLOXAN B Ifosfamide - 1g 1g Injectable powder for solution 3,586,850 L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE G Bendamustine HCl - 25mg/10ml 25mg/10ml Injectable powder for concentrate for solution 19,610,153 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (25mg) 2.5mg/ml Injectable powder for concentrate for solution 24,934,922 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE G Bendamustine HCl - 100mg/50ml 100mg/50ml Injectable powder for concentrate for solution 78,439,178 L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE GP PHARM G Bendamustine HCl - 100mg/50ml 100mg/50ml Injectable powder for concentrate for solution 78,439,178 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (100mg) 2.5mg/ml Injectable powder for concentrate for solution 16,887,989 L.L
L01AA09 BENDAVIVAL G Bendamustine HCl - 100mg 100mg Injectable concentrated powder for solution 26,072,618 L.L
L01AC01 TEPADINA G Thiotepa - 100mg 100mg Injectable powder for concentrate for solution 98,197,306 L.L
L01AX03 TEMODAL B Temozolomide - 250mg 250mg Capsule 18,516,505 L.L
L01AX03 TEGOZOL G Temozolomide - 250mg 250mg Capsule 24,856,894 L.L
L01AX03 TEMOZOLOMIDE ACCORD G Temozolomide - 250mg 250mg Capsule, hard 13,397,927 L.L
L01AX03 TEMOZOLOMIDE GP PHARM G Temozolomide - 250mg 250mg Capsule, hard 12,058,004 L.L
L01AX03 TEMODAL B Temozolomide - 100mg 100mg Capsule 7,731,224 L.L
L01AX03 TEGOZOL G Temozolomide - 100mg 100mg Capsule 5,012,533 L.L
L01AX03 TEMOZOLOMIDE ACCORD G Temozolomide - 100mg 100mg Capsule, hard 5,590,385 L.L
L01AX03 TEMOZOLOMIDE GP PHARM G Temozolomide - 100mg 100mg Capsule, hard 4,511,279 L.L
L01AX03 TEMODAL B Temozolomide - 20mg 20mg Capsule 1,612,611 L.L
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