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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
L01FG01 MVASI BioTech Bevacizumab - 400mg/16ml 400mg/16ml Injectable concentrate for solution 58,035,926 L.L
L01FG01 MVASI BioTech Bevacizumab - 100mg/4ml 100mg/4ml Injectable concentrate for solution 17,173,671 L.L
L01FX02 MYLOTARG BioTech Gemtuzumab Ozogamicin - 4.5mg 4.5mg Injectable powder 748,160,090 L.L
B01AD11 METALYSE BioTech Tenecteplase - 10,000IU 10,000IU Injectable powder for solution+diluent 77,815,572 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 613,662 L.L
N06DX01 MEMORA G Memantine HCl - 10mg 10mg Tablet, film coated 849,820 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 344,754 L.L
A01AB09 MICONAZ G Miconazole nitrate - 20mg/g 20mg/g Gel 229,093 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
J01CA04 MOXILEN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 3,717,068 L.L
N06DX01 MEMANTINE ARROW LAB G Memantine HCl - 20mg 20mg Tablet, film coated 1,342,499 L.L
A01AB09 MICOZOLE G Miconazole - 20mg/g 20mg/g Gel 104,820 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
N06DX01 MEMANTINE BIOGARAN G Memantine HCl - 20mg 20mg Tablet, coated 2,444,450 L.L
A01AB09 MYCOHEAL G Miconazole nitrate - 20mg/g 20mg/g Gel 210,983 L.L
N06DX01 MEMORA G Memantine HCl - 20mg 20mg Tablet, film coated 1,593,413 L.L
N07AA01 METHYL SULFATE DE NEOSTIGMINE RENAUDIN G Neostigmine methyl sulfate - 0.5mg/ml 0.5mg/ml Injectable solution 467,657 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 329,815 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 494,147 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 430,943 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 326,367 L.L
L01DB07 MITOXANTRON EBEWE G Mitoxantrone - 20mg/10ml 20mg/10ml Injectable concentrated solution 11,064,120 L.L
R05CA03 MUCINEX G Guaifenesin - 600mg 600mg Tablet, extended release 749,864 L.L
A06AG11 MINILAX G Sodium citrate (dihydrate) - 900mg/10ml, Sodium lauryl sulfate - 150mg/10ml, Glycerol - 1200mg/10ml, Sorbic acid - 10mg/10ml, Sorbitol - 9.96mg/10ml Solution 474,824 L.L
J01CA04 MOXILEN G Amoxicillin (sodium) - 1g 1g Injectable dry powder for solution 998,475 L.L
M05BA04 MARVIL 70 G Alendronate (monosodium trihydrate) - 70mg 70mg Tablet, coated 1,173,175 L.L
D07AC13 METASONE G Mometasone furoate - 0.1% 0.1% Cream 335,321 L.L
A02BB01 MISOFAR G Misoprostol - 200mcg 200mcg Tablet 1,546,763 L.L
A02BB01 MISOFAR G Misoprostol - 25mcg 25mcg Tablet 1,855,846 L.L
J01CR02 MOXICLAV G Amoxicillin - 1g, Clavulanic Acid - 200mg 1.2g Injectable powder for solution 169,324 L.L
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