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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
L04AX04 LEDOBOOK 10 G Lenalidomide - 10mg 10mg Capsule 62,230,245 L.L
M04AA03 FEBUXOSTAT BIOGARAN G Febuxostat - 120mg 120mg Tablet, film coated 1,402,972 L.L
N03AB02 PHENTOLEP INJECTION G Phenytoin (sodium) - 250mg/5ml 250mg/5ml Injectable solution 1,447,318 L.L
N07BC01 BUPENSAN G Buprenorphine - 8mg 8mg Tablet 1,259,180 L.L
R05CA12 LIBLAB COUGH SUPPOSITORIES G Dried Ivy leaf extract - 80mg 80mg Suppository 142,447 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 1,198,595 L.L
A03FA01 ? METOCLOPRAMIDE INJECTION USP G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 84,470 L.L
A10BB12 GLYPRIDE G Glimepiride - 2mg 2mg Tablet 403,153 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 216,046 L.L
B05XA05 SULFATE DE MAGNESIUM RENAUDIN G Magnesium sulfate - 1.5g/10ml 15% Injectable solution 434,061 L.L
D01BA02 LAMINOX G Terbinafine HCl - 250mg 250mg Tablet 725,675 L.L
H02AB07 PREDICOR G Prednisone - 5mg 5mg Tablet, scored 174,060 L.L
J02AX04 CANDIGARD G Caspofungin (acetate) - 50mg 50mg Injectable powder for concentrate for solution 22,127,179 L.L
L01CD01 PANATAXEL G Paclitaxel - 30mg/5ml 30mg/5ml Injectable concentrated solution 3,563,870 L.L
L01XA02 CARBOPLATINE VIATRIS 10MG/ML G Carboplatin - 50mg/5ml 50mg/5ml Injectable solution 906,050 L.L
L04AX04 LENALIDOMIDE NEAPOLIS G Lenalidomide - 10mg 10mg Capsule 72,248,183 L.L
M04AA03 OXUBAT 120 G Febuxostat - 120mg 120mg Tablet, film coated 1,549,002 L.L
N03AB02 ? PHENYTOIN SODIUM 5% USP G Phenytoin (sodium) - 250mg/5ml 5ml Injectable solution 276,448 L.L
N05AX08 DEPIA G Risperidone - 2mg 2mg Tablet, scored 307,164 L.L
N07BC01 BUPRENORPHINE ARROW G Buprenorphine - 8mg 8mg Tablet 1,671,740 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 10,787,353 L.L
A10BB12 JOSWE GLEMAX 2 G Glimepiride - 2mg 2mg Caplet 326,554 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 50g/100ml 50g/100ml Injectable solution 897,510 L.L
C08CA01 AMLINE G Amlodipine - 5mg 5mg Tablet, scored 358,358 L.L
D01BA02 TERAFAN G Terbinafine HCl - 250mg 250mg Tablet, scored 725,675 L.L
H02AB07 PREDNISONE G Prednisone - 5mg 5mg Tablet, scored 176,619 L.L
J02AX04 CASPOFUNGINE STRAGEN G Caspofungin (acetate) - 50mg 50mg Injectable concentrated powder for solution 18,712,833 L.L
L01CD01 PATAXEL G Paclitaxel - 30mg/5ml 30mg/5ml Injectable concentrate for solution 2,447,137 L.L
L01XA03 OXALIPLATIN HOSPIRA G Oxaliplatin - 100mg/20ml 5mg/ml Injectable concentrated solution 8,471,583 L.L
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