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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
R03DC03 MONTELUKAST ARROW LAB G Montelukast (sodium) - 4mg 4mg Tablet, chewable 851,996 L.L
R03DC03 MONTELUKAST-SANDOZ G Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,139,034 L.L
R03DC03 RELIEFAST G Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,034,119 L.L
R03DC03 ROMILAST G Montelukast (sodium) - 4mg 4mg Tablet, mouth dissolving 405,840 L.L
R03DC03 UNICAST G Montelukast (sodium) - 4mg 4mg Tablet, chewable 783,460 L.L
R03DC03 SINGULAIR PAEDIATRIC B Montelukast (sodium) - 4mg 4mg Granules 1,248,430 L.L
R03DC03 AIRFAST PEDIATRICS G Montelukast (sodium) - 4mg 4mg Granules for solution 880,217 L.L
R03DC03 LEUKOTRIS G Montelukast - 5mg 5mg Tablet 979,085 L.L
R03DC03 LEUKOTRIS G Montelukast - 4mg 4mg Tablet 783,268 L.L
R03DX05 XOLAIR BioTech Omalizumab - 150mg 150mg Injectable lyophilised powder for solution+diluent 52,297,174 L.L
R03DX05 XOLAIR BioTech Omalizumab - 150mg 150mg Injectable solution 37,110,724 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
R05 COQUELUSEDAL NOURRISSON G Grindelia extract - 10mg, Gelsenium extract - 5mg Suppository 496,170 L.L
R05 EXALL FORTE G Chlorpheniramine maleate - 2.5mg, Guaifenesin - 100mg, Acetaminophen - 100mg, Diprophylline - 25mg Syrup 501,701 L.L
R05 COQUELUSEDAL ENFANT G Grindelia extract - 20mg, Gelsenium extract - 10mg Suppository 575,270 L.L
R05C PULMONAL SIROP G Belladona tincture - 0.5g/5ml, Drosera tincture - 2g/5ml, Ammonium bromide - 2g/5ml, Sodium benzoate - 2g/5ml Syrup 148,463 L.L
R05C SULDEX G Caffein anyhdrous - 0.216g, Antipyrine - 0.972g, Potassium sulfaguaiacolate - 1.44g Syrup 152,302 L.L
R05CA ASPECTON COUGH SYRUP G Thyme soft extract - 6.69g/100ml Syrup 588,603 L.L
R05CA03 MUCINEX G Guaifenesin - 600mg 600mg Tablet, extended release 749,864 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract (Hedera Helix) - 99mg/5ml 99mg/5ml Drops solution 384,339 L.L
R05CA12 LIBLAB COUGH SUPPOSITORIES G Dried Ivy leaf extract - 80mg 80mg Suppository 142,447 L.L
R05CA12 PROSPAN ACUTE EFFERVESCENT COUGH TABLETS B Dried Ivy leaf extract - 65mg Tablet, effervescent 479,752 L.L
R05CA12 PROSPAN COUGH LIQUID B Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Liquid 353,431 L.L
R05CA12 PROSPAN COUGH SYRUP B Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Solution 353,431 L.L
R05CA12 IVY-CALM G Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Syrup 251,299 L.L
R05CA12 IVYMUC G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
R05CA12 TOUCALM G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
R05CA12 JOS-PAN G Dried Ivy leaf extract (Hederacoside C) - 75mg/100ml Syrup 306,396 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
R05CA12 LIBLAB COUGH SYRUP G Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Syrup 237,860 L.L
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