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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
L01CE02 IRNOCAM 100 G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable solution 7,320,947 L.L
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
N05CD08 IPNODIS MEDIS G Midazolam - 5mg/ml 5mg/ml Injectable solution 565,758 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 2.5g/50ml 2.5g/50ml Injectable solution 17,011,323 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 28,622,366 L.L
J06BA02 IMMUNOREL BioHuman Human normal immunoglobulin - 5g/100ml 5% Injectable solution 29,700,912 L.L
J06BA02 IMMUNOREL BioHuman Human normal immunoglobulin - 2.5g/50ml 5% Injectable solution 14,850,456 L.L
M01AC01 INFLACAM G Piroxicam - 20mg/ml 20mg/ml Injectable solution 190,826 L.L
L03AB03 IMUKIN BioTech Interferon gamma - 100mcg/0.5ml 100mcg/0.5ml Injectable suspension 6,348,312 L.L
J07BB01 INFLUVAC TETRA B Influenza virus surface antigens inactivated (haemagglutinin and neuraminidase) - 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
R07AA INFASURF B Calfactant - 210mg/6ml 35mg/ml Injectable suspension 40,596,749 L.L
R07AA INFASURF B Calfactant - 105mg/3ml 35mg/ml Injectable suspension 23,344,161 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
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
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 100mg 100mg Injectable suspension, prolonged release 18,342,148 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 75mg 75mg Injectable suspension, prolonged release 14,659,577 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 50mg 50mg Injectable suspension, prolonged release 9,661,754 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 150mg 150mg Injectable suspension, prolonged release 26,434,190 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
G01AF05 IFENEC G Econazole nitrate - 150mg 150mg Ovule 546,944 L.L
R01AX ISOTONIC SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Solution 153,582 L.L
M01AB01 INDOCID B Indometacin - 100mg 100mg Suppository 424,910 L.L
M01AB01 INDOMEL G Indometacin - 100mg 100mg Suppository 222,694 L.L
M01AE01 IBUSOL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 309,724 L.L
R05CA12 IVY-CALM G Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Syrup 251,299 L.L
R05CA12 IVYMUC G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
C09CA04 IRBESARTAN ARROW G Irbesartan - 150mg 150mg Tablet 470,345 L.L
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