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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
J05AR01 LAMIVUDINE/ ZIDOVUDINE ARROW G Lamivudine - 150mg, Zidovudine - 300mg Tablet, coated, scored 15,643,319 L.L
J05AR03 TRUVADA B Emtricitabine - 200mg, Tenofovir disoproxil - 245mg Tablet, film coated 20,507,286 L.L
J05AR03 EMZAVIR G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg Tablet, film coated 18,701,506 L.L
J05AR06 VITRICOMB G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg, Efavirenz - 600mg Tablet, film coated 22,191,783 L.L
J05AR10 KALUVIA G Lopinavir - 200mg, Ritonavir - 50mg Tablet, film coated 7,632,790 L.L
J05AR12 TELADINE G Lamivudine - 300mg, Tenofovir disoproxil fumarate - 300mg Tablet 17,454,739 L.L
J05AR13 TRIUMEQ B Dolutegravir - 50mg, Abacavir sulfate - 600mg, Lamivudine - 300mg Tablet, film coated 74,756,237 L.L
J05AR18 GENVOYA B Emtricitabine - 200mg, Tenofovir alafenamide - 10mg, Elvitegravir - 150mg, Cobicistat - 150mg Tablet, film coated 74,826,489 L.L
J05AR20 BIKTARVY B Bictegravir - 50mg, Emtricitabine - 200mg, Tenofovir alafenamide - 25mg Tablet, film coated 73,652,468 L.L
J05AR24 DELSTRIGO B Lamivudine - 300mg, Tenofovir disoproxil - 300mg, Doravirine - 100mg Tablet, film coated 48,879,793 L.L
J05AR27 DOLUTEGRAVIR/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE G Lamivudine - 300mg, Tenofovir disoproxil fumarate - 300mg, Dolutegravir - 50mg Tablet 54,836,160 L.L
J05AX12 TIVICAY B Dolutegravir - 50mg 50mg Tablet, film coated 54,508,037 L.L
J05AX18 PREVYMIS B Letermovir - 240mg 240mg Tablet, film coated 460,943,945 L.L
J05AX18 PREVYMIS B Letermovir - 480mg 480mg Tablet, film coated 961,233,292 L.L
J05AX18 PREVYMIS B Letermovir - 240mg/12ml 240mg/12ml Injectable concentrate for solution 25,111,114 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 10g/200ml 10g/200ml Injectable solution 53,767,929 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 10g/100ml 10g/100ml Injectable solution 54,343,313 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 71,676,672 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 10% 10% Injectable solution 76,970,900 L.L
J06BA02 HIZENTRA 1G BioHuman Immunoglobulin human - 1g/5ml 20% Injectable solution 9,246,433 L.L
J06BA02 HIZENTRA 2G BioHuman Immunoglobulin human - 2g/10ml 20% Injectable solution 17,658,835 L.L
J06BA02 CUVITRU BioHuman Human normal immunoglobulin - 4g/20ml 200mg/ml Injectable solution 29,806,627 L.L
J06BA02 CUVITRU BioHuman Human normal immunoglobulin - 8g/40ml 200mg/ml Injectable solution 53,593,818 L.L
J06BA02 HIZENTRA 4G BioHuman Immunoglobulin human - 4g/20ml 20% Injectable solution 35,323,423 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 1g/20ml 1g/20ml Injectable solution 7,474,948 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 2.5g/50ml 2.5g/50ml Injectable solution 17,011,323 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 2.5g/25ml 10% Injectable solution 23,611,268 L.L
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