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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
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
L02BA01 TAMOXIFEN SANDOZ G Tamoxifen (citrate) - 20mg 20mg Tablet, film coated 497,222 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 20mg 20mg Tablet 858,715 L.L
L01XK04 TALZENNA B Talazoparib - 1mg 1mg Capsule 401,512,167 L.L
L01XK04 TALZENNA B Talazoparib - 0.25mg 0.25mg Capsule 133,836,699 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution 375,054,619 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution 375,054,619 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1875mg/15ml 1875mg/15ml Injectable solution 375,054,619 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution L.L
L01FD01 TRASTUREL BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder 52,047,114 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 440mg 440mg Injectable powder for solution+solvent 75,295,202 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 150mg 150mg Injectable powder for solution 28,550,630 L.L
L01FD01 TRASTUREL BioTech Trastuzumab - 440mg L.L
L01FA01 TRUXIMA BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 31,060,158 L.L
L01FA01 TRUXIMA BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 69,144,591 L.L
L01EH01 TYKERB B Lapatinib ditosylate - 250mg 250mg Tablet, film coated 101,971,611 L.L
L01EB04 TAGRISSO B Osimertinib - 80mg 80mg Tablet, film coated 603,192,941 L.L
L01EB02 TARESSA 100 G Erlotinib (HCl) - 100mg 100mg Tablet, film coated 82,247,256 L.L
L01EB02 TARESSA 150 G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 98,617,813 L.L
L01EA03 TASIGNA B Nilotinib - 200mg 200mg Capsule 395,037,357 L.L
L01EA03 TASIGNA B Nilotinib - 150mg 150mg Capsule 310,220,984 L.L
L01CE01 TOPOTU G Topotecan HCl - 4mg/4ml 4mg/4ml Injectable concentrated solution 7,253,796 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 20mg/ml 20mg/ml Injectable concentrated solution+diluent 6,574,078 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 20mg/ml 20mg/ml Injectable concentrated solution+diluent 6,574,078 L.L
L01AX03 TEMODAL B Temozolomide - 250mg 250mg Capsule 18,516,505 L.L
L01AX03 TEGOZOL G Temozolomide - 250mg 250mg Capsule 24,856,894 L.L
L01AX03 TEMOZOLOMIDE ACCORD G Temozolomide - 250mg 250mg Capsule, hard 13,397,927 L.L
L01AX03 TEMOZOLOMIDE GP PHARM G Temozolomide - 250mg 250mg Capsule, hard 12,058,004 L.L
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