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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
L01EG02 AFINITOR B Everolimus - 10mg 10mg Tablet 205,782,764 L.L
C03DA01 ALDACTONE B Spironolactone - 100mg 100mg Tablet 458,250 L.L
J07BC02 AVAXIM PEDIATRIQUE (vaccin inactivé de l'hépatite A adsorbé) B Hepatitis A, inactivated, whole virus - 80 antigen units/0.5ml 80 antigen units/0.5ml Injectable suspension 1,531,980 L.L
A07EC02 ASACOL B Mesalazine - 500mg 500mg Suppository 1,703,992 L.L
C03DA01 ALDACTONE B Spironolactone - 25mg 25mg Tablet 237,860 L.L
N02BA01 ASPIRINE B Acetylsalicylic acid - 300mg 0.3g Tablet 80,631 L.L
N02BA51 ASPIRINE C EFFERVESCENT B Acetylsalicylic acid - 400mg, Vitamin C - 240mg Tablet, effervescent 162,605 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 L.L
L04AA13 ARAVA B Leflunomide - 10mg 10mg Tablet, film coated 2,230,779 L.L
R06AX27 AERIUS B Desloratadine - 0.5mg/ml 0.5mg/ml Solution 403,153 L.L
L04AA13 ARAVA B Leflunomide - 20mg 20mg Tablet, film coated 3,346,168 L.L
A07EC02 ASACOL B Mesalazine - 1g/100ml 1g/100ml Enema 2,748,158 L.L
M01AE51 ADVIL COLD & SINUS B Ibuprofen - 200mg, Pseudoephedrine HCl - 30mg Caplet, coated 288,926 L.L
A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 8,454,523 L.L
C09CA04 APROVEL B Irbesartan - 300mg 300mg Tablet, film coated 651,764 L.L
A07EC02 ASACOL B Mesalazine - 1600mg 1600mg Tablet, modified release 12,310,378 L.L
C09CA04 APROVEL B Irbesartan - 300mg 300mg Tablet, film coated 651,764 L.L
C05A ANTROLIN B Nifedipine - 0.3%, Lidocaine - 1.5% Cream 1,333,092 L.L
J07BX05 ABRYSVO B RSV subgroup A stabilized perfusion F antigen 60mcg - 60mcg, RSV subgroup B stabilized perfusion F antigen 60mcg - 60mcg, Glycoprotein F stabilized in the perfusion conformation - Injectable powder + solvent 22,650,721 L.L
D10AD06 AKLIEF B Trifarotene - 50mcg/g 50mcg/g Cream 4,359,425 L.L
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 L.L
C09CA06 ATACAND B Candesartan cilexetil - 8mg 8mg Tablet 526,786 L.L
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release L.L
C09CA06 ATACAND B Candesartan cilexetil - 16mg 16mg Tablet 705,517 L.L
C05BB02 AETHOXYSKLEROL B Polidocanol (Lauromacrogol 400) - 0.5% 0.5% Injectable solution 1,441,943 L.L
C05BB02 AETHOXYSKLEROL B Polidocanol (Lauromacrogol 400) - 1% 1% Injectable solution 1,732,213 L.L
M01AH05 ARCOXIA B Etoricoxib - 60mg 60mg Tablet, film coated 1,685,178 L.L
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