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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
A11GA01 VITAMIN C S.A.L.F. G Ascorbic acid (vit C) - 500mg/5ml 500mg/5ml Injectable solution 498,566 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
C10BA05 OTOREZA 10/10 G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 454,219 L.L
G01AF DERMOFIX GYNO OVULE G Sertaconazole nitrate - 300mg 300mg Ovule 790,996 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 438,093 L.L
J02AC01 FLUNAZOL G Fluconazole - 50mg/5ml 50mg/5ml Powder for suspension 756,391 L.L
L01BC05 GEMNIL G Gemcitabine (HCl) - 200mg 200mg Injectable powder for solution 1,128,828 L.L
N02BE51 GENTLE RELIEF G Paracetamol - 325mg, Ibuprofen - 400mg, Famotidine - 20mg Tablet 184,106 L.L
N05AH04 JOSWE QUZAL 25 G Quetiapine - 25mg 25mg Tablet 490,503 L.L
N06DA02 ARIPEZIL 10 G Donepezil HCl - 10mg 10mg Tablet, film coated 2,292,595 L.L
R03DC03 LUKAST G Montelukast (sodium) - 5mg 5mg Tablet, chewable 783,460 L.L
S01ED51 EPISOPT G Timolol - 5mg, Dorzolamide HCl - 20mg Drops 575,165 L.L
A10BA02 GLUCOBAS G Metformin - 850mg 850mg Tablet 217,575 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
C07AB07 B-COR 10 G Bisoprolol fumarate - 10mg 10mg Tablet, film coated 595,322 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 4,542,188 L.L
J02AC01 MYXEN G Fluconazole - 50mg/5ml 50mg/5ml Granules for suspension 793,507 L.L
L01BC05 GEMTABINE 200 G Gemcitabine HCl - 200mg 200mg Injectable lyophilised powder for solution 1,343,843 L.L
N05AH04 PMS-QUETIAPINE G Quetiapine fumarate - 25mg 25mg Tablet 814,369 L.L
N06DA02 DONECEPT 10 G Donepezil HCl - 10mg 10mg Tablet, film coated 2,292,595 L.L
R03DC03 MONTELUKAST ARROW LAB G Montelukast (sodium) - 5mg 5mg Tablet, chewable 851,996 L.L
S01ED51 TWINZOL G Dorzolamide HCl - 2%, Timolol - 0.5% Drops solution 632,950 L.L
A03AA04 SPASMINE (Mebeverine HCl 200mg SR) G Mebeverine HCl - 200mg 200mg Capsule, slow release 712,876 L.L
A10BA02 GLUFORIN 850 G Metformin HCl - 850mg 850mg Tablet, film coated 316,123 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 166,708 L.L
C07AB07 BISCORDEX G Bisoprolol fumarate - 10mg 10mg Tablet 789,667 L.L
C09DA04 ANDARAN PLUS G Irbesartan - 300mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 575,270 L.L
G01AF02 CANAGYN G Clotrimazole - 100mg 100mg Tablet 229,797 L.L
J01DD04 VERACOL G Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 454,219 L.L
L01BC05 HAXANIT G Gemcitabine (HCl) - 200mg 200mg Injectable lyophilised powder 1,411,035 L.L
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