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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
J01FA09 KLACID B Clarithromycin - 500mg 500mg Injectable powder for solution 1,428,505 L.L
J01CA04 AMOXYCILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 4,073,187 L.L
J01CA04 MOXILEN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 3,717,068 L.L
N03AX14 KEPPRA B Levetiracetam - 500mg 500mg Tablet, film coated 6,478,288 L.L
N03AX14 KEPCITAM G Levetiracetam - 500mg 500mg Tablet, film coated 2,933,608 L.L
J01FA09 KLACID RM B Clarithromycin - 500mg 500mg Tablet, modified release 1,173,175 L.L
N03AX14 LEPITAM G Levetiracetam - 500mg 500mg Tablet 1,100,671 L.L
N03AX14 LEVETIRACETAM ARROW LAB G Levetiracetam - 500mg 500mg Tablet, film coated, breakable 2,441,762 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 500mg 500mg Tablet, coated, scored 2,651,401 L.L
N03AX14 LEVIPHAR G Levetiracetam - 500mg 500mg Tablet, film coated 1,451,350 L.L
P02DA01 TAENIASAN G Niclosamide - 500mg 500mg Tablet 94,709 L.L
N03AX14 LEVIPRAM 500 G Levetiracetam - 500mg 500mg Tablet, film coated 1,663,805 L.L
P02DA01 TENIADEX G Niclosamide - 500mg 500mg Tablet 70,392 L.L
N03AX14 ZITERA G Levetiracetam - 500mg 500mg Tablet, film coated 2,203,902 L.L
L01EA04 BOSULIF B Bosutinib - 500mg 500mg Tablet, film coated 154,453,246 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
B03BA05 COBAL G Mecobalamine - 500mcg/ml 500mcg/ml Injectable solution 1,128,828 L.L
C01EA01 PROSTIN VR B Alprostadil - 500mcg/ml 500mcg/ml Injectable concentrated solution 19,894,577 L.L
R03BB01 ATROVENT B Ipratropium bromide - 500mcg/2ml 500mcg/2ml Inhaltion solution with nebuliser 713,580 L.L
C01CA06 PHENYLEPHRINE AGUETTANT G Phenylephrine - 500mcg/10ml 500mcg/10ml Injectable solution 11,464,796 L.L
B03BA01 COBAL G Vitamin B12 - 500mcg 500mcg Tablet, coated 486,471 L.L
B02BD02 ESPEROCT BioTech Turoctocog Alfa pegol (recombinant coagulation factor VIII) - 500IU/Vial 500IU/Vial Injectable powder for solution+diluent 38,126,657 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
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