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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
J01DD08 SUPRAX B Cefixime (trihydrate) - 400mg 400mg Capsule 2,053,391 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 5mg Tablet, film coated 1,158,392 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 10mg Tablet, film coated 1,245,742 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
N06AX27 SPRAVATO B Esketamine - 28mg/device 28mg/device Solution 25,122,440 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 66,978,978 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 44,561,381 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 25,122,440 L.L
H02AB09 SOLU CORTEF ACT-O-VIAL B Hydrocortisone (sodium succinate) - 250mg 250mg Injectable lyophilised powder for solution+diluent 421,967 L.L
L04AD01 SANDIMMUN B Ciclosporin - 50mg/ml 250mg/5ml Injectable concentrated solution 6,992,013 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 50mg 50mg Capsule, soft gelatin 4,309,703 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 25mg 25mg Capsule, soft gelatin 2,385,320 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 100mg 100mg Capsule, soft gelatin 8,264,592 L.L
L04AD01 SANDIMMUN NEORAL B Ciclosporin - 100mg/ml 100mg/ml Solution 8,264,592 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
N06BX06 SOMAZINA B Citicoline - 1000mg/sachet 1000mg/sachet Solution 974,286 L.L
R03BB06 SEEBRI BREEZHALER B Glycopyronium Bromide - 50mcg 50mcg Capsule, inhalation 2,687,685 L.L
N06BX06 SOMAZINA B Citicoline (sodium) - 1,000mg/4ml 1,000mg/4ml Injectable solution 787,492 L.L
N02BE51 SOLPADEINE B Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet 319,835 L.L
N02BE51 SOLPADEINE SOLUBLE B Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet, effervescent 326,554 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 120mg 120mg Injectable solution L.L
R03DC03 SINGULAIR (PEDIATRIC) B Montelukast (sodium) - 5mg 5mg Tablet, chewable 1,217,521 L.L
S01EC54 SIMBRINZA B Brinzolamide - 1%, Brimonidine tartrate - 0.2% Drops suspension 1,706,680 L.L
R03DC03 SINGULAIR B Montelukast (sodium) - 10mg 10mg Tablet, film coated 1,248,430 L.L
M03BX02 SIRDALUD B Tizanidine HCl - 2mg 2mg Tablet 659,104 L.L
M03BX02 SIRDALUD B Tizanidine HCl - 4mg 4mg Tablet 862,769 L.L
R03DC03 SINGULAIR PEDIATRIC B Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,217,521 L.L
N05AL05 SOLIAN B Amisulpride - 100mg 100mg Tablet, scored 1,048,197 L.L
N05AL05 SOLIAN B Amisulpride - 400mg 400mg Tablet, film-scored 1,764,465 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
    4
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