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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
B05BB02 HI-SODIUM INJECTION WITH POTASSIUM G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
C09AA05 NORMOPRIL G Ramipril - 2.5mg 2.5mg Tablet 229,797 L.L
C10AA03 APO-PRAVASTATIN G Pravastatin Sodium - 40mg 40mg Tablet 958,160 L.L
D07AA02 HYDROCORTISONE ACETATE G Hydrocortisone acetate - 1% 1% Cream 215,015 L.L
J01CR02 VAAMOX IV G Amoxicillin - 1g, Clavulanic Acid - 200mg Injectable powder 2,150,148 L.L
J01FA10 ZEVLEN G Azithromycin (dihydrate) - 250mg 250mg Tablet, film coated 409,552 L.L
L02BG06 EXEMESTANE ARROW G Exemestane - 25mg 25mg Tablet, film coated 3,386,483 L.L
N03AX16 GALICA 75 G Pregabalin - 75mg 75mg Capsule 338,648 L.L
R01AD09 AVOCOM G Mometasone furoate - 0.05% 0.05% Spray 419,279 L.L
R06AX DESLOCORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 673,201 L.L
A04AA01 VOMITRON G Ondansetron - 16mg 16mg Suppository 578,492 L.L
A10BD08 VLUDIN MET G Metformin HCl - 850mg, Vildagliptin - 50mg Tablet, film coated 735,914 L.L
B01AC24 KLOTEGO G Ticagrelor - 90mg 90mg Tablet, film coated 2,598,096 L.L
B05BB02 LO-SODIUM INJECTION G Sodium lactate - 0.223g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Potassium chloride - 0.149g/100ml, Sodium chloride - 0.0585g/100ml, Dextrose, H2O - 5.0g/100ml Injectable solution 179,456 L.L
C01DX12 MOLSIDOMINE BIOGARAN G Molsidomine - 4mg 4mg Tablet 344,024 L.L
C09AA05 TRILTEC G Ramipril - 2.5mg 2.5mg Capsule 255,970 L.L
C10AA03 PRAVASTATINE ARROW G Pravastatin - 40mg 40mg Tablet, breakable 526,786 L.L
G04BD07 TOREDA G Tolterodine (tartrate) - 2mg 2mg Tablet, film coated 2,311,409 L.L
J01FA10 ZIMAX G Azithromycin (dihydrate) - 250mg 250mg Capsule 360,150 L.L
L01EB01 APO-GEFITINIB G Gefitinib - 250mg 250mg Tablet 87,345,820 L.L
L02BG06 EXEMESTANE BGR G Exemestane - 25mg 25mg Tablet, coated 4,479,027 L.L
M01AE01 CAPTAIN G Ibuprofen - 200mg 200mg Capsule, soft gelatin 383,955 L.L
N03AX16 NERVAX G Pregabalin - 75mg 75mg Capsule 513,348 L.L
N06AB05 APO-PAROXETINE G Paroxetine (HCl) - 20mg 20mg Tablet 1,099,263 L.L
R01AD09 METASONE G Mometasone furoate - 50mcg/actuation 50mcg/actuation Spray 419,791 L.L
R06AX FRENALER CORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 741,801 L.L
L01XG01 BORTEZOMIB NEAPOLIS G Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution L.L
A04AA01 VOMITRON G Ondansetron - 16mg 16mg Suppository 304,604 L.L
B01AC24 KLOTEGO G Ticagrelor - 60mg 60mg Tablet, film coated 2,598,096 L.L
B05BB02 LO-SODIUM WITH POTASSIUM INJECTION G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate - 0.223g/100ml, Sodium chloride - 0.0585g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
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