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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
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 0.5% 0.5% Injectable solution 1,995,158 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 500mg 500mg Tablet, coated, scored 2,651,401 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 561,726 L.L
P02DA01 TAENIASAN G Niclosamide - 500mg 500mg Tablet 94,709 L.L
R06AD02 PROMETHAZINE HYDROCHLORIDE G Promethazine HCl - 5mg/5ml 5mg/5ml Syrup 204,776 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for injection - Water for injection, irrigation 264,311 L.L
A04AA01 ONDANSETRON BIOGARAN G Ondansetron - 8mg 8mg Tablet, coated 1,307,559 L.L
A10BD02 DIAMET 500/5 G Metformin HCl XR - 500mg, Glibenclamide - 5mg Tablet, film coated 639,925 L.L
B01AC04 ANTIPLEX G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,295,464 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 158,587 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
D06AX01 ACIDE FUSIDIQUE BGR G Fusidic acid - 2% 2% Cream 202,920 L.L
J01CA01 AMPICILLIN G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
J01FA09 CLAMYCIN G Clarithromycin - 250mg 250mg Tablet, film coated 641,205 L.L
J05AR01 CONDINE G Lamivudine - 150mg, Zidovudine - 300mg Tablet, film coated 5,818,474 L.L
L01EA01 IMATINIB GP PHARM G Imatinib - 100mg 100mg Tablet, coated 26,083,945 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 10mg 10mg Tablet 106,164 L.L
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 1% 1% Injectable solution 1,995,158 L.L
N03AX14 LEVIPHAR G Levetiracetam - 500mg 500mg Tablet, film coated 1,451,350 L.L
N05CD08 MIDAZOLAM PANPHARMA G Midazolam - 5mg/ml 5mg/ml Injectable solution 826,463 L.L
P02DA01 TENIADEX G Niclosamide - 500mg 500mg Tablet 70,392 L.L
R06AD02 PROMETAL G Promethazine - 25mg 25mg Tablet 194,537 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 203,405 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, film coated 748,520 L.L
B01AC04 APO-CLOPIDOGREL G Clopidogrel (Bisulfate), - 75mg 75mg Tablet 911,125 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 179,272 L.L
C01CA03 NORADRENALINE RENAUDIN G Norepinephrine tartrate - 8mg/4ml 0.2% Injectable solution 2,000,981 L.L
C08DB01 APO-DILTIAZ G Diltiazem HCl - 60mg 60mg Tablet 545,600 L.L
D06AX01 DERMICIN G Fusidic acid - 20mg/g 20mg/g Cream 175,339 L.L
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