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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
N05AX13 TREVICTA B Paliperidone - 525mg 525mg Injectable suspension, prolonged release 72,306,028 L.L
N05AX13 BYANNLI B Paliperidone - 1000mg 1000mg Injectable suspension, prolonged release 135,844,746 L.L
N05AX13 BYANNLI B Paliperidone - 700mg 700mg Injectable suspension, prolonged release 93,221,562 L.L
J07AJ51 BOOSTRIX B Diphteria toxoid purified - ?2.5Lf/0.5ml, Tetanus toxoid purified - ?5Lf/0.5ml, Bordetella Pertussis Antigens: toxoid - 8mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 8mcg/0.5ml, Pertactine - 2.5mcg Al3+/0.5ml, Aluminium hydroxide - 0.3mg Al3+/0.5ml, Aluminium Phosphate - 0.2mg/0.5ml Injectable suspension 1,394,909 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
L03AB03 IMUKIN BioTech Interferon gamma - 100mcg/0.5ml 100mcg/0.5ml Injectable suspension 6,348,312 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
J07AL02 PNEUMOSIL (10-VALENT) G Pneumococcal polysaccharide conjugate vaccine (adsorbed) - Injectable suspension 3,386,483 L.L
J07AL02 PREVENAR 20 B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F,8, 9V,10A, 11A, 12F, 14, 15B, 18C, 19A, 19F,22F, 23F, 33F (2.2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein (approximately 51mcg) adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 7,415,107 L.L
J07AL02 VAXNEUVANCE B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 22F, 23F,33F (2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg) Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate adjuvant - Injectable suspension 6,988,413 L.L
J07AP03 TYPHIBEV TYPHOID CONJUGATED VACCINE (MONOVALENT) B Salmonella typhi polysaccharides Vi purified - 25mcg of Vi-PS2/0.5ml Injectable suspension 4,020,777 L.L
J07BB01 INFLUVAC TETRA B Influenza virus surface antigens inactivated (haemagglutinin and neuraminidase) - 15mcg/4strains/0.5ml Injectable suspension 970,254 L.L
J07BB01 VAXIGRIPTETRA, VACCIN GRIPPAL QUADRIVALENT (INACTIVE A VIRION FRAGMENTE) B Influenza vaccine virus (inactivated, split) - 15mcg/4strains/0.5ml Injectable suspension 970,254 L.L
J07BB02 INFLUVAC B Grippal virus surface antigen 3strains - 15mcgx3strains/0.5ml Injectable suspension 573,821 L.L
J07BC01 ENGERIX-B 20 B Hepatitis B, purified antigen - 20mcg/ml 20mcg/ml Injectable suspension 1,652,926 L.L
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
J07BC01 HEPATITIS-B VACCINE (r DNA) PAEDIATRIC G Hepatitis B, purified surface antigen adsorbed on aluminium hydroxide (Al+++) (0.25mg to 0.40mg) - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 323,866 L.L
J07BC02 HAVRIX '1440' B Hepatitis A, inactivated, whole virus - 1,440 ELISA units/ml 1,440 ELISA units/ml Injectable suspension 2,215,996 L.L
J07BC02 HAVRIX JUNIOR 720 B Hepatitis A, inactivated, whole virus - 720 ELISA units/0.5ml 720 ELISA units/0.5ml Injectable suspension 1,491,665 L.L
J07BC02 AVAXIM PEDIATRIQUE (vaccin inactivé de l'hépatite A adsorbé) B Hepatitis A, inactivated, whole virus - 80 antigen units/0.5ml 80 antigen units/0.5ml Injectable suspension 1,531,980 L.L
J07BC02 VAQTA B Hepatitis A, inactivated, whole virus - 25U/0.5ml 25U/0.5ml Injectable suspension 2,539,862 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 0.5ml/dose 0.5ml/dose Injectable suspension 1,777,904 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 1ml/dose 0.5ml/dose Injectable suspension 2,257,655 L.L
J07BF03 POLIOMYELITIS VACCINE INACTIVATED B Poliomyelitis virus type 1 inactivated - 40D.U, Poliomyelitis virus type 2 inactivated - 8D.U, Poliomyelitis virus type 3 inactivated - 32D.U Injectable suspension 1,206,771 L.L
L02AE03 ZOLADEX LA B Goserelin (acetate) - 10.8mg 10.8mg Injectable suspension L.L
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
R07AA INFASURF B Calfactant - 210mg/6ml 35mg/ml Injectable suspension 40,596,749 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
R07AA INFASURF B Calfactant - 105mg/3ml 35mg/ml Injectable suspension 23,344,161 L.L
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