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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
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
A10AB04 HUMALOG BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable suspension 1,988,887 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable suspension 1,503,312 L.L
A10AD01 HUMULIN 70/30 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A10AD01 JUSLINE BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 401,809 L.L
A10AD01 MIXTARD 30 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 752,552 L.L
A10AD01 MIXTARD 30 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 752,552 L.L
A10AD04 HUMALOG MIX 50 KWIKPEN BioTech Insulin lispro solution - 50%, Insulin lispro protamine suspension - 50% 100IU/ml Injectable suspension 3,950,897 L.L
A10AD04 HUMALOG MIX 25 KWIKPEN BioTech Insulin lispro solution - 25%, Insulin lispro protamine suspension - 75% 100IU/ml Injectable suspension 3,950,897 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AE01 HUMULIN N U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A10AE01 INSULATARD BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 752,552 L.L
A10AE01 INSULATARD BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 752,552 L.L
A10AE01 JUSLINE N BioTech Insulin human isophane - 100IU/ml 100IU/ml Injectable suspension 401,809 L.L
H02AB01 DIPROFOS B Betamethasone (dipropionate) - 5mg/ml, Betamethasone (sodium phosphate) - 2mg/ml Injectable suspension 446,156 L.L
L01BC07 AZACITIDINE ARROW G Azacitidine - 25mg/ml 25mg/ml Injectable suspension 10,967,854 L.L
H02AB04 DEPO MEDROL B Methylprednisolone acetate - 40mg/ml 40mg/ml Injectable suspension 182,763 L.L
N02CD02 EMGALITY BioTech Galcanezumab - 120mg/ml 120mg/ml Injectable suspension 37,250,732 L.L
H02AB04 DEPO MEDROL B Methylprednisolone acetate - 80mg/2ml 80mg/2ml Injectable suspension 365,525 L.L
H02AB08 TRIACORT G Triamcinolone acetonide - 40mg/ml 40mg/ml Injectable suspension 745,833 L.L
L02AE03 ZOLADEX DEPOT B Goserelin (acetate) - 3.6mg 3.6mg Injectable suspension 8,820,074 L.L
L02AE03 ZOLADEX LA B Goserelin (acetate) - 10.8mg 10.8mg Injectable suspension 35,121,328 L.L
J01DD04 LEBACEF G Ceftriaxone - 1g 1g Injectable sterile powder for solution + lidocaine solvent 508,100 L.L
J01DD04 LEBACEF G Ceftriaxone - 1g 1g Injectable sterile powder for solution + lidocaine solvent 508,100 L.L
A02BC01 ULCAZAL G Omeprazole (sodium) - 40mg 40mg Injectable sterile lyophilised powder for solution 895,895 L.L
A02BC01 ULCAZAL G Omeprazole (sodium) - 40mg 40mg Injectable sterile lyophilised powder for solution 5,916,747 L.L
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