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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
N01BB54 EMLA B Prilocaine - 25mg/g, Lidocaine - 25mg/g 5% Cream 1,763,121 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
D06AX PENICILLIN DERMIC OINTMENT G Penicillin - 5,000IU 5,000IU Ointment 80,631 L.L
G03GA01 CHORIOMON BioHuman Human Chorionic Gonadotrophin - 5,000IU 5,000IU Injectable lyophilised powder for solution+diluent 4,031,528 L.L
M03AX01 XEOMIN BioTech Clostridium botulinum type A neurotoxin complex - 50 units LD50 50 units LD50 Injectable powder for solution 11,920,109 L.L
B05CX01 GLUCOSE INJ. G Glucose - 10g/20ml 50% Injectable solution 5,038,066 L.L
A11CC05 ALTUM G Vitamin D3 - 50,000IU 50,000IU Capsule, hard 712,620 L.L
A11CC05 BIODAL G Vitamin D3 - 50,000IU 50,000IU Tablet, film coated 1,110,014 L.L
A11CC05 D-VITAL G Vitamin D3 - 50,000IU 50,000IU Capsule, hard 712,620 L.L
A11CC05 EURO D HP 50.000 IU G Vitamin D3 - 50,000IU 50,000IU Capsule 1,432,536 L.L
A11CC05 DIBASE G Vitamin D3 - 50000IU/2.5ml 50,000IU/2.5ml Solution 755,239 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU 500,000IU Capsule 417,231 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU/5ml 500,000IU/5ml Suspension 415,951 L.L
A11CC05 D-ESTER G Vitamin D3 - 50000IU 50000IU Capsule 1,187,701 L.L
A11CC05 HI DEE G Vitamin D3 - 50000IU 50000IU Capsule, soft gelatin 518,723 L.L
A11CC05 MEGAVIT-D 50 G Vitamin D3 - 50000IU 50000IU Capsule 1,940,253 L.L
A11CC05 MEGAVIT-D 50 G Vitamin D3 - 50000IU 50000IU Capsule 3,687,248 L.L
A11CC05 HI DEE G Vitamin D3 - 5000IU 5000IU Capsule, soft gelatin 740,457 L.L
B02BD04 BENEFIX BioTech Nonacog alfa (recombinant coagulation factor IX) - 500IU 500IU Injectable powder for solution+diluent L.L
B02BD01 OCTAPLEX BioHuman Prothrombin complex, human (PPSB) - 500IU 500IU Injectable powder for solution+diluent 37,682,862 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 27,354,631 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 26,495,478 L.L
B02BD02 NOVOEIGHT BioTech Turoctocog Alfa - 500IU 500IU Injectable powder for solution+diluent 29,783,973 L.L
B02BD02 NUWIQ BioTech Coagulation Factor VIII recombinant, human (Simoctogog alfa) - 500IU 500IU Injectable powder for solution+diluent 45,612,427 L.L
B02BD02 RECOFACT VIII BioTech Moroctocog alfa - 500IU 500IU Injectable powder for solution+diluent 12,049,005 L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent 23,067,288 L.L
B02BD04 OCTANINE F BioHuman Plasma coagulation factor IX, human - 500IU 500IU Injectable freeze dried powder + diluent 31,425,075 L.L
B02BD04 BENEFIX BioTech Nonacog alfa (recombinant coagulation factor IX) - 500IU 500IU Injectable powder for solution+diluent 27,390,281 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 500IU 500IU Injectable powder for solution+solvent 76,080,435 L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent L.L
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