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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
A03BB01 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 692,079 L.L
A03BB01 BUSCOPAN B Butylscopolamine bromide - 10mg 10mg Tablet, sugar coated 291,614 L.L
N06AA02 TOFRANIL 10 B Imipramine HCl - 10mg 10mg Tablet, sugar coated 579,772 L.L
A03CA02 LIBRAX DRAGEES B Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 435,405 L.L
N06AA02 TOFRANIL 25 B Imipramine HCl - 25mg 25mg Tablet, sugar coated 1,002,123 L.L
A03CA02 BIPAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 363,477 L.L
N06AA21 LUDIOMIL B Maprotiline - 10mg 10mg Tablet, sugar coated 867,738 L.L
N06AA21 MEFIDIOMIL B Maprotiline - 25mg 25mg Tablet, sugar coated 909,973 L.L
N06AA21 MEFIDIOMIL B Maprotiline - 75mg 75mg Tablet, sugar coated 958,608 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 520,067 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 219,046 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 2mg, Naloxone HCl - 0.5mg Tablet, sublingual 1,473,590 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 8mg, Naloxone HCl - 2mg Tablet, sublingual 7,382,584 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 16mg, Naloxone HCl - 4mg Tablet, sublingual 14,284,125 L.L
N05BA12 TRANQUINAL 0.5 SUBLINGUAL G Alprazolam - 0.5mg 0.5mg Tablet, sublingual 459,594 L.L
R03DA05 AMINOPHYLLINE G Aminophylline - 100mg 100mg Tablet, scored 445,388 L.L
J01RA MEDSPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
J01RA SPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
J01RA SPIRAGYL FORTE G Metronidazole - 250mg, Spiramycin - 1,500,000IU Tablet, scored 474,824 L.L
C09CA06 CANDESARTAN BIOGARAN G Candesartan cilexetil - 8mg 8mg Tablet, scored 434,061 L.L
C09CA06 CANDESARTAN BIOGARAN G Candesartan cilexetil - 16mg 16mg Tablet, scored 434,061 L.L
C09CA06 CANDESARTAN BIOGARAN G Candesartan cilexetil - 32mg 32mg Tablet, scored 434,061 L.L
N02BE51 MAXIFEN G Paracetamol - 325mg, Ibuprofen - 400mg Tablet, scored 225,254 L.L
C07AA05 APO-PROPRANOLOL G Propranolol HCl - 10mg 10mg Tablet, scored 280,863 L.L
N05AL05 SOLIAN B Amisulpride - 100mg 100mg Tablet, scored 1,048,197 L.L
C07AA05 APO-PROPRANOLOL G Propranolol HCl - 40mg 40mg Tablet, scored 356,118 L.L
M03BC51 MUSCEROL 2 G Paracetamol - 450mg, Orphenadrine (citrate) - 35mg Tablet, scored 177,899 L.L
M03BC51 MUSCEROL EXTRA G Caffeine - 15mg, Paracetamol - 450mg, Orphenadrine citrate - 35mg Tablet, scored 267,489 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 160mg 160mg Tablet, scored 357,462 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 80mg 80mg Tablet, scored 288,926 L.L
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