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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
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 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 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
J07AX URO-VAXOM B Lyophilized bacterial lysates of E-Coli - 6mg 6mg Capsule 2,689,029 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 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
J07BD52 PRIORIX B Rubella virus live attenuated - ?10³ CCID50, Mumps virus live attenuated - ?103.7 CCID50, Measles virus live attenuated - ?10³ CCID50 Injectable lyophilised powder for solution+diluent 1,142,266 L.L
J07BD52 M-M-R II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE) B Rubella virus live attenuated - , Mumps virus live attenuated - , Measles virus live attenuated - Injectable solution+diluent 12,924,401 L.L
J07BD52 MEASLES, MUMPS AND RUBELLA VACCINE LIVE ATTENUATED (FREEZE-DRIED) MMR G Rubella virus live attenuated - ?1000CCID50 /0.5ml, Mumps virus live attenuated - ?5000CCID50 /0.5ml, Measles virus live attenuated - ?1000CCID50 /0.5ml Injectable freeze dried powder + diluent 739,113 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
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
J07BH01 ROTATEQ ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT B Rotavirus G1, live attenuated - ?2.2x106 IU, Rotavirus G2, live attenuated - ?2.8x106 IU, Rotavirus G3, live attenuated - ?2.2x106 IU, Rotavirus G4, live attenuated - ?2.0x106 IU, Rotavirus P1, live attenuated - ?2.3x106 IU Suspension 4,508,592 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 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
J07BK01 VARILRIX + SOLVENT IN SYRINGE B Varicella virus, live attenuated - ?1033 PFU ?1033 PFU Injectable lyophilised powder for solution+diluent 3,473,833 L.L
J07BK01 VARIVAX B Varicella virus, live attenuated - 1350PFU Injectable powder for suspension+diluent 4,102,751 L.L
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