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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
M04AA03 OXUBAT 80 G Febuxostat - 80mg 80mg Tablet, film coated 1,549,002 L.L
N03AF01 NEUROTOP RETARD G Carbamazepine - 300mg 300mg Tablet, prolonged release 931,283 L.L
R05CA12 TOUCALM G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
A03FA03 NAUZEX G Domperidone - 10mg 10mg Tablet 258,530 L.L
A10BB12 GLIM G Glimepiride - 3mg 3mg Tablet 533,505 L.L
B05BB01 SOLUFLEX 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 264,311 L.L
C08CA01 AMLODIPINE ARROW G Amlodipine (besylate) - 5mg 5mg Capsule 462,282 L.L
D02AF POMMADE ACIDE SALICYLIQUE G Salicylic acid - 10% 10% Ointment 284,127 L.L
H02AB07 PREDICOR G Prednisone - 50mg 50mg Tablet, scored 712,876 L.L
L01CD01 PACLITAXEL NEAPOLIS G Paclitaxel - 150mg/25ml 150mg/25ml Injectable concentrate for solution 15,665,972 L.L
L04AX04 SOTIRA G Lenalidomide - 10mg 10mg Capsule 72,248,183 L.L
M04AA03 STABURIC G Febuxostat - 80mg 80mg Tablet, film coated 1,355,489 L.L
N05AX08 DEPIA G Risperidone - 4mg 4mg Tablet, scored 499,142 L.L
R05CA12 JOS-PAN G Dried Ivy leaf extract (Hederacoside C) - 75mg/100ml Syrup 306,396 L.L
A03FA03 NOVADOM G Domperidone - 10mg 10mg Tablet 278,175 L.L
A10BB12 GLUMYL 3 G Glimepiride - 3mg 3mg Tablet 511,940 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 129,934 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE C G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.33g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 204.54g/l Injectable solution L.L
C08CA01 AMLODIPINE BIOGARAN G Amlodipine (besylate) - 5mg 5mg Capsule 462,282 L.L
D02AF VERRUFILM G Lactic acid - 16.7%, Salicylic acid - 16.7% Solution 861,403 L.L
G03AD01 PURPLE LINE G Levonorgestrel - 1.5mg 1.5mg Tablet, film coated 1,071,570 L.L
H02AB07 PREDNISONE G Prednisone - 50mg 50mg Tablet, scored 742,313 L.L
J05AB01 ASIMPLEX G Aciclovir - 250mg 250mg Injectable lyophilised powder for solution 278,175 L.L
L01CD01 PANATAXEL G Paclitaxel - 150mg/25ml 150mg/25ml Injectable concentrated solution 16,521,761 L.L
L01XA03 OXALIPLATIN EBEWE G Oxaliplatin - 50mg/10ml 50mg/10ml Injectable concentrated solution 3,405,297 L.L
N05AX08 PMS-RISPERIDONE G Risperidone - 4mg 4mg Tablet 1,276,650 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
A03FA03 PROKININ G Domperidone - 10mg 10mg Tablet, film coated 221,734 L.L
A10BB12 GLYPRIDE G Glimepiride - 3mg 3mg Tablet 571,133 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
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