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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
C08DA01 ISOPTIN SR B Verapamil (HCl) - 240mg 240mg Tablet, film coated, prolonged release 1,085,822 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 491,846 L.L
J01FA02 ROVAMYCINE B Spiramycin - 3MIU 3MIU Tablet, film coated 649,076 L.L
J05AP55 EPCLUSA B Sofosbuvir - 400mg, Velpatasvir - 100mg Tablet, film coated 954,137,511 L.L
C08DA51 TARKA B Verapamil - 180mg, Trandolapril - 2mg Capsule, modified release 2,422,948 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,523,917 L.L
D06AX01 FUCIDIN CREAM B Fusidic acid - 2% 2% Cream 345,368 L.L
J01FA02 ROVAMYCINE B Spiramycin - 1.5MIU 1.5MIU Tablet, film coated 256,674 L.L
J05AP56 VOSEVI B Sofosbuvir - 400mg, Velpatasvir - 100mg, Voxilaprevir - 100mg Tablet, film coated 857,670,718 L.L
C08DA51 TARKA B Verapamil - 240mg, Trandolapril - 4mg Tablet, modified release 3,797,532 L.L
L02BB03 CASODEX B Bicalutamide - 50mg 50mg Tablet, film coated 3,777,541 L.L
A10BD02 GLUCOVANCE B Metformin HCl - 1000mg, Glibenclamide - 5mg Tablet, film coated 967,891 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,523,917 L.L
N05CF02 STILNOX B Zolpidem (tartrate) - 10mg 10mg Tablet, film coated, scored 96,757 L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 6,971,989 L.L
A10BD02 GLIBOMET B Metformin HCl - 400mg, Glibenclamide - 5mg Tablet, film coated 462,282 L.L
J05AR03 TRUVADA B Emtricitabine - 200mg, Tenofovir disoproxil - 245mg Tablet, film coated 20,507,286 L.L
R06AD08 TOPLEXIL B Oxomemazine HCl - 0.33mg/ml 0.33mg/ml Syrup 615,480 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 20mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,482,258 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Tablet, film coated 1,329,060 L.L
N03AX14 KEPPRA B Levetiracetam - 1000mg 1,000mg Tablet, film coated 12,202,941 L.L
A10BD05 ACTOSMET B Metformin - 850mg, Pioglitazone - 15mg Tablet, film coated 3,101,588 L.L
M01AB16 AIRTAL 100MG 20 B Aceclofenac - 100mg 100mg Tablet, film coated 471,689 L.L
N05CM18 PRECEDEX (DEXMEDETOMIDINE) B Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable solution 19,441,512 L.L
A10BD06 DUETACT B Glimepiride - 2mg, Pioglitazone - 30mg Tablet 2,803,255 L.L
C08DB01 MONO-TILDIEM LP/SR B Diltiazem HCl - 200mg 200mg Capsule, sustained release 658,483 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,523,917 L.L
D06AX01 FUCIDIN B Fusidic acid (sodium salt) - 20mg/g 2% Ointment 259,362 L.L
L01EA02 SPRYCEL B Dasatinib - 70mg 70mg Tablet 212,274,841 L.L
A10BD06 DUETACT B Glimepiride - 4mg, Pioglitazone - 30mg Tablet 3,287,039 L.L
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