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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
M01AE17 KETESSE B Dexketoprofen (trometamol) - 50mg/2ml 50mg/2ml Injectable solution 435,405 L.L
N02BE01 PANADOL ADVANCE B Paracetamol - 500mg 500mg Tablet, film coated 438,093 L.L
R03AK06 SERETIDE DISKUS 500 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 500mcg/inhalation Inhalation powder 3,199,689 L.L
C03BA04 HYGROTON B Chlortalidone - 50mg 50mg Tablet 422,351 L.L
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
N02BE01 PANADOL ADVANCE B Paracetamol - 500mg 500mg Tablet, film coated 137,072 L.L
A06AX05 RESOLOR B Prucalopride succinate - 1mg 1mg Tablet, film coated 3,273,600 L.L
C03BA11 FLUDEX B Indapamide - 1.5mg 1.5mg Tablet, sustained release 517,379 L.L
L04AA13 ARAVA B Leflunomide - 10mg 10mg Tablet, film coated 2,230,779 L.L
N02BE01 PANADOL ADVANCE B Paracetamol - 500mg 500mg Tablet, film coated 389,714 L.L
N04BB01 PK-MERZ B Amantadine (sulfate) - 100mg 100mg Tablet, film coated 1,382,814 L.L
B01AF02 ELIQUIS B Apixaban - 5mg 5mg Tablet, film coated 4,183,603 L.L
J07BC02 HAVRIX '1440' B Hepatitis A, inactivated, whole virus - 1,440 ELISA units/ml 1,440 ELISA units/ml Injectable suspension 2,215,996 L.L
M01AE51 ADVIL COLD & SINUS B Ibuprofen - 200mg, Pseudoephedrine HCl - 30mg Caplet, coated 288,926 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
A10BH02 GALVUS B Vildagliptin - 50mg 50mg Tablet 950,097 L.L
C03CA01 LASIX B Furosemide - 40mg 40mg Tablet 120,946 L.L
C09CA01 COZAAR B Losartan potassium - 100mg 100mg Tablet 1,740,596 L.L
J07BC02 HAVRIX JUNIOR 720 B Hepatitis A, inactivated, whole virus - 720 ELISA units/0.5ml 720 ELISA units/0.5ml Injectable suspension 1,491,665 L.L
L04AA13 ARAVA B Leflunomide - 20mg 20mg Tablet, film coated 3,346,168 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 631,606 L.L
R06AX29 LABIXTEN B Bilastine - 20mg 20mg Tablet 584,571 L.L
A02BB01 CYTOTEC B Misoprostol - 200mcg 200mcg Tablet 737,770 L.L
D07XA01 DAKTACORT B Hydrocortisone - 10mg/g, Miconazole nitrate - 20mg/g Cream 208,296 L.L
J01MA06 NOROXIN B Norfloxacin - 400mg 400mg Tablet, film-scored 574,653 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
L01EH01 TYKERB B Lapatinib ditosylate - 250mg 250mg Tablet, film coated 101,971,611 L.L
R06AX29 LABIXTEN B Bilastine - 2.5mg/ml 2.5mg/ml Solution 463,626 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release L.L
J01MA12 TAVANIC 500MG B Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 1,988,887 L.L
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