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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
N02BE51 HUMEX RHUME B Pseudoephedrine HCl (tablet) - 60mg, Paracetamol (tablet) - 500mg, Paracetamol (capsule) - 500mg, Chlorphenamine maleate (capsule) - 4mg Tablet, capsule 467,657 L.L
R03DC03 SINGULAIR PEDIATRIC B Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,217,521 L.L
A05AA02 URSOFALK B Ursodeoxycholic acid - 250mg 250mg Capsule 2,823,413 L.L
J01DI01 ZEVTERA B Ceftobiprole medocaril Sodium - 500mg 500mg Injectable powder for concentrate for solution 47,129,773 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 10mg Tablet, film coated 4,482,387 L.L
L01XG01 VELCADE B Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution 23,616,000 L.L
N02BF02 LYRICA B Pregabalin - 150mg 150mg Capsule 3,041,116 L.L
N05AL05 SOLIAN B Amisulpride - 100mg 100mg Tablet, scored 1,048,197 L.L
L01EA03 TASIGNA B Nilotinib - 200mg 200mg Capsule L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 10mg Tablet, film coated 4,482,387 L.L
D06BX01 ROZEX B Metronidazole - 0.75g/100g 0.75% Gel 584,571 L.L
J01DI54 ZERBAXA B Ceftolozane Sulfate - 1g, Tazobactam (sodium) - 0.5g Injectable powder for concentrate for solution 74,780,802 L.L
N02BF02 LYRICA B Pregabalin - 150mg 150mg Capsule 3,041,116 L.L
N05AL05 SOLIAN B Amisulpride - 400mg 400mg Tablet, film-scored 1,764,465 L.L
S01EE01 XALATAN B Latanoprost - 50mcg/ml 50mcg/ml Drops solution 704,173 L.L
C01EA01 PROSTIN VR B Alprostadil - 500mcg/ml 500mcg/ml Injectable concentrated solution 19,894,577 L.L
N06DX01 EBIXA B Memantine HCl - 10mg 10mg Tablet, film coated 2,143,429 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 520,067 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,482,387 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 1,603,204 L.L
J01EE01 BACTRIM FORTE B Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 344,024 L.L
M04AA03 ADENURIC B Febuxostat - 120mg 120mg Tablet, film coated 2,184,704 L.L
A06AB02 DULCOLAX B Bisacodyl - 5mg 5mg Tablet, sugar coated 219,046 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,482,387 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 3,205,064 L.L
C01EB15 VASTAREL B Trimetazidine - 35mg 35mg Tablet, film coated, modified release 1,053,573 L.L
C09AA05 TRITACE B Ramipril - 10mg 10mg Tablet 689,391 L.L
D07AB02 LOCOID B Hydrocortisone butyrate - 1mg/g 0.1% Cream 215,015 L.L
    ...
    189
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