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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
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,228,091 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
B01AC04 CERUVIN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 240,548 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,894 L.L
C01BC04 FLECAINIDE ARROW LAB G Flecainide acetate - 100mg 100mg Tablet, scored 588,603 L.L
C08CA05 NIFELAT 30 LA G Nifedipine - 30mg 30mg Tablet, prolonged release 1,007,882 L.L
C09DX01 VIOSTAN AM PLUS 160/10/12.5 G Valsartan - 160mg, Amlodipine - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,196,020 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
G03DA04 PROGEST 200 G Progesterone micronised - 200mg 200mg Capsule, soft gelatin 411,216 L.L
J01DH02 AROPEM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 995,723 L.L
J05AF05 LAMIVUDINE ARROW G Lamivudine - 150mg 150mg Tablet, coated, scored 7,850,907 L.L
L01CE02 IRINOGEN G Irinotecan HCl - 100mg 100mg Injectable solution 5,239,642 L.L
L04AX07 MAROVAREX G Dimethyl Fumarate - 120mg 120mg Capsule, hard, gastro-resistant 9,838,676 L.L
M05BA07 PMS-RISEDRONATE G Risedronate sodium - 35mg 35mg Tablet 674,609 L.L
N03AX09 LAMOTRIGINE ARROW LAB G Lamotrigine - 25mg 25mg Tablet, dispersible/ chewable 556,351 L.L
N05AX12 JOSWE ARIPAL 5 G Aripiprazole - 5mg 5mg Tablet 1,389,533 L.L
R05CB06 SOLVAMUC SR G Ambroxol - 75mg 75mg Capsule 276,448 L.L
S03CA04 MYCICORT G Hydrocortisone acetate - 5mg, Neomycin sulfate - 5mg Drops suspension 166,381 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
B01AC04 CLODOR G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 1,148,025 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 100mg 100mg Capsule, extended release 1,154,361 L.L
C08CA05 NIFELAT 60 LA G Nifedipine - 60mg 60mg Tablet, prolonged release 1,290,089 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable powder for solution 995,723 L.L
J05AF05 VICONDINE G Lamivudine - 150mg 150mg Tablet, film coated 3,573,725 L.L
L01CE02 IRINOTECAN GP PHARM G Irinotecan HCl trihydrate - 100mg/5ml 100mg/5ml Injectable concentrated solution 5,239,642 L.L
L04AX07 MAROVAREX G Dimethyl Fumarate - 240mg Capsule, hard, gastro-resistant 60,848,734 L.L
M05BA07 RISEDRONATE ARROW G Risedronate sodium - 35mg 35mg Tablet, film coated 671,921 L.L
N03AX09 LAMOTRIGINE BIOGARAN G Lamotrigine - 25mg 25mg Tablet, dispersible 595,322 L.L
    ...
    159
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