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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
J05AB01 VICLORIX 800 G Aciclovir - 800mg 800mg Tablet 4,321,797 L.L
L01CD02 DOCETAXEL SPC G Docetaxel - 80mg/4ml 80mg/4ml Injectable concentrate for solution 16,906,027 L.L
L04AX04 SOTIRA G Lenalidomide - 15mg 15mg Capsule 76,208,289 L.L
M05BA04 MARVIL 70 G Alendronate (monosodium trihydrate) - 70mg 70mg Tablet, coated 1,173,175 L.L
N05AX12 ABIPREX 10 G Aripiprazole - 10mg 10mg Tablet 1,075,074 L.L
N07CA01 BETAHISTINE ARROW G Betahistine dihydrochloride - 16mg 16mg Tablet 362,837 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
A03FA07 GAROPRIDE G Itopride Hydrochloride - 50mg 50mg Tablet, film coated 213,671 L.L
A10BB12 GLUMYL 4 G Glimepiride - 4mg 4mg Tablet 317,403 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 180,421 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 TORANS G Amlodipine (besylate) - 5mg 5mg Tablet 518,339 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 5mg Capsule, hard 1,368,032 L.L
G03CA03 VAGIFEM G Estradiol (hemihydrate) - 10mcg 10mcg Tablet 2,254,968 L.L
H02B PREDALONE PLUS G Prednisolone sodium phosphate - 10mg/5ml, Dexchlorpheniramine maleate - 2mg/5ml Syrup 890,776 L.L
J01DE01 CEFEPIME PANPHARMA G Cefepime - 1g 1g Injectable powder for solution 5,933,065 L.L
L01XG01 ALVOCADE G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 14,169,600 L.L
M05BA04 OREK G Alendronate - 70mg 70mg Tablet, coated 2,404,838 L.L
N05AX12 ATYPRAL G Aripiprazole - 10mg 10mg Tablet 712,237 L.L
N07CA01 VASOSERC FORTE G Betahistine dihydrochloride - 16mg 16mg Tablet 944,529 L.L
R05CB02 BROMHEXINE G Bromhexine - 4mg/5ml 4mg/5ml Elixir 176,619 L.L
A03FA08 CINITREX G Cinitapride - 1mg 1mg Tablet 636,981 L.L
A10BB12 GLYPRIDE G Glimepiride - 4mg 4mg Tablet 657,139 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 226,388 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 AMLINE G Amlodipine - 10mg 10mg Tablet 662,962 L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
D03BA SERODASE G Serratiopeptidase - 5mg 5mg Tablet, enteric coated 460,938 L.L
G03CA03 MONTADIOL G Estradiol - 0.01% 0.01% Cream 1,105,982 L.L
J01DE01 CEFIPEX 1000 BENTA G Cefepime - 1,000mg 1,000mg Injectable dry powder+diluent 703,918 L.L
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