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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
N01AB07 SUPRANE (DESFLURANE, USP) B Desflurane - Inhalation 9,371,654 L.L
A03AX13 SIMETHICONE G Dimethicone - 2g/100ml 2g/100ml Emulsion 212,327 L.L
A07BC05 SMECTALIA B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
A07BC05 SMECTALIA STRAWBERRY B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
J05AG03 STOVIRENZ G Efavirenz - 600mg 600mg Tablet, film coated 6,857,456 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,399,653 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,399,653 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,287,711 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 1000mg 5mg/1000mg Tablet, film coated 3,399,653 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 850mg 5mg/850mg Tablet, film coated 3,287,711 L.L
D10AF02 SPOTEX G Erythromycin - 4% 4% Gel 854,684 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 66,978,978 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 44,561,381 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 25,122,440 L.L
N06AX27 SPRAVATO B Esketamine - 28mg/device 28mg/device Solution 25,122,440 L.L
A02BC05 SOLEZOL G Esomeprazole - 40mg 40mg Injectable powder for solution 301,021 L.L
M04AA03 STABURIC G Febuxostat - 120mg 120mg Tablet, film coated 1,420,889 L.L
M04AA03 STABURIC G Febuxostat - 40mg 40mg Tablet, film coated 1,081,345 L.L
M04AA03 STABURIC G Febuxostat - 80mg 80mg Tablet, film coated 1,355,489 L.L
G04CB01 STERIBO G Finasteride - 1mg 1mg Tablet, film coated 2,636,619 L.L
G04CB01 STERIFINE 5 G Finasteride - 5mg 5mg Tablet, film coated 733,354 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule L.L
J02AC01 STABILANOL G Fluconazole - 100mg 100mg Capsule 1,432,331 L.L
J02AC01 STABILANOL G Fluconazole - 150mg 150mg Capsule 264,637 L.L
J02AC01 STABILANOL G Fluconazole - 2mg/ml 2mg/ml Injectable solution 1,291,789 L.L
N06CA02 SERNIL G Flupentixol - 0.5mg, Melitracen - 10mg Tablet 1,003,402 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
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