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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
B01AD12 CEPROTIN BioHuman Protein C Human - 1000IU 1000IU Injectable powder for solution+diluent 172,581,517 L.L
B02BD02 ESPEROCT BioTech Turoctocog Alfa pegol (recombinant coagulation factor VIII) - 1000IU/Vial 1000IU/Vial Injectable powder for solution+diluent 75,761,363 L.L
B01AC27 UPTRAVI B Selexipag - 1000mcg 1000mcg Tablet, film coated 275,097,581 L.L
B03BA01 JECTIN-12 G Cyanocobalamin - 1000mcg/1ml 1000mcg/1ml Injectable solution 567,102 L.L
J01CR02 AMOKLAVIN BID G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1000mg Tablet, film coated 448,843 L.L
A07EC02 SALOFALK B Mesalazine - 1000mg 1000mg Granules, gastro-resistant, prolonged release 3,874,298 L.L
N05AX13 BYANNLI B Paliperidone - 1000mg 1000mg Injectable suspension, prolonged release 141,224,257 L.L
A07EC02 SALCROZINE G Mesalazine - 1000mg 1000mg Suppository 2,306,034 L.L
N03AX14 KEPCITAM G Levetiracetam - 1000mg 1000mg Tablet, film coated 3,119,058 L.L
N03AX14 LEVETIRACETAM ARROW LAB G Levetiracetam - 1000mg 1000mg Tablet, film coated, breakable 2,940,327 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 1000mg 1000mg Tablet, coated, scored 3,191,626 L.L
N03AX14 LEVIPHAR G Levetiracetam - 1000mg 1000mg Tablet, film coated 2,212,861 L.L
N03AX14 LEVIPRAM 1000 G Levetiracetam - 1000mg 1000mg Tablet, film coated 1,663,805 L.L
A10BA02 GLUCOBAS G Metformin - 1000mg 1000mg Tablet 302,045 L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 1000mg 1000mg Tablet, film coated, scored 237,860 L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 1000mg 1000mg Tablet, film coated, scored 689,391 L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 1000mg 1000mg Tablet, film coated, scored 237,860 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 1000mg 1000mg Tablet, prolonged release 755,039 L.L
A16AX BICANORM G Sodium bicarbonate - 1000mg 1000mg Tablet, gastroresistant 2,623,181 L.L
N02BE01 DOLIPRANE B Paracetamol - 1,000mg 1000mg Tablet 120,946 L.L
N02BE01 DOLIPRANE B Paracetamol - 1000mg 1000mg Tablet 120,946 L.L
N02BE01 SICADOL G Paracetamol - 1000mg 1000mg Tablet 423,310 L.L
L01BC05 GEMCITABINE NEAPOLIS G Gemcitabine (HCl) - 1000mg 1000mg Injectable powder for solution 4,942,653 L.L
N03AX14 LEVIPRAM IV G Levetiracetam - 1000mg/100ml 1000mg/100ml Injectable solution 2,911,659 L.L
N02BE01 PARACETAMOL B.BRAUN G Paracetamol - 1000mg/100ml 1000mg/100ml Injectable solution 129,009 L.L
L01BC01 CYTU G Cytarabine - 1000mg/10ml 1000mg/10ml Injectable solution 2,230,779 L.L
L01BC02 5-FLUOROURACIL EBEWE G Fluorouracil - 1000mg/20ml 1000mg/20ml Injectable concentrated solution 653,107 L.L
L01BC02 5-FROTU G Fluorouracil - 1000mg/20ml 1000mg/20ml Injectable solution 577,852 L.L
L01BA04 PEMETREXED STRAGEN G Pemetrexed (disodium) - 1000mg/40ml 1000mg/40ml Injectable concentrate for solution 40,480,209 L.L
L01FA03 GAZYVA BioTech Obinutuzumab - 1000mg/40ml 1000mg/40ml Injectable concentrate for solution 314,437,416 L.L
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