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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
L01EB04 TAGRISSO B Osimertinib - 80mg 80mg Tablet, film coated 603,192,941 L.L
N03AX11 TOPAMAX 25 B Topiramate - 25mg 25mg Tablet, film coated 858,715 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
J07AP03 TYPHIBEV TYPHOID CONJUGATED VACCINE (MONOVALENT) B Salmonella typhi polysaccharides Vi purified - 25mcg of Vi-PS2/0.5ml Injectable suspension 4,020,777 L.L
N03AX11 TOPAMAX B Topiramate - 50mg 50mg Tablet, film coated 1,914,976 L.L
J01MA12 TAVANIC 500MG B Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 1,988,887 L.L
N03AX11 TOPAMAX B Topiramate - 100mg 100mg Tablet, film coated 3,471,145 L.L
J01MA12 TAVANIC B Levofloxacin - 500mg 500mg Tablet, film-scored 1,150,329 L.L
J01MA12 TAVANIC B Levofloxacin - 500mg 500mg Tablet, film coated, scored 1,150,329 L.L
N06AA02 TOFRANIL 10 B Imipramine HCl - 10mg 10mg Tablet, sugar coated 579,772 L.L
N06AA02 TOFRANIL 25 B Imipramine HCl - 25mg 25mg Tablet, sugar coated 1,002,123 L.L
N06AA09 TRYPTIZOL B Amitryptiline (HCl) - 10mg 10mg Tablet, coated 695,234 L.L
R06AD08 TOPLEXIL B Oxomemazine HCl - 0.33mg/ml 0.33mg/ml Syrup 615,480 L.L
N06AA09 TRYPTIZOL B Amitryptiline (HCl) - 25mg 25mg Tablet, coated 716,716 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 661,171 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 1,662,333 L.L
R01AB06 TRIOFAN B Xylometazoline HCl - 0.5mg/ml, Carbocysteine - 5mg/ml Spray, solution 608,761 L.L
R01AB06 TRIOFAN B Xylometazoline HCl - 1mg/ml, Carbocysteine - 10mg/ml Spray, solution 646,388 L.L
L01EH01 TYKERB B Lapatinib ditosylate - 250mg 250mg Tablet, film coated 101,971,611 L.L
B03AE10 TOT'HEMA B Copper (gluconate) - 0.70mg/10ml, Manganese (gluconate) - 1.33mg/10ml, Iron (gluconate) - 50mg/10ml Solution 604,729 L.L
J07CA02 TETRAXIM (Vaccin Diphterique, tetanique, coquelucheux acellulaire et Poliomyelitique inactivé adsorbé) B Diphteria toxoid purified - ?30IU, Tetanus toxoid purified - ?40IU, Poliomyelitis virus type 1 inactivated - 40D.U., Poliomyelitis virus type 2 inactivated - 8D.U., Poliomyelitis virus type 3 inactivated - 32D.U., Bordetella Pertussis Antigens: toxoid - 25mcg, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg Injectable suspension 1,628,737 L.L
C07AB03 TENORMIN B Atenolol - 50mg 50mg Tablet, film coated 393,746 L.L
C07AB03 TENORMIN B Atenolol - 100mg 100mg Tablet, film coated 279,519 L.L
L01AX03 TEMODAL B Temozolomide - 250mg 250mg Capsule 18,516,505 L.L
L01AX03 TEMODAL B Temozolomide - 100mg 100mg Capsule 7,731,224 L.L
N02AX02 TRAMAL B Tramadol HCl - 50mg 50mg Capsule 349,399 L.L
N02AX02 TRAMAL 100MG B Tramadol HCl - 100mg/2ml 100mg/2ml Injectable solution 243,235 L.L
L01AX03 TEMODAL B Temozolomide - 20mg 20mg Capsule 1,612,611 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 100mg 100mg Tablet, modified release 236,516 L.L
N02AX02 TRAMAL RETARD B Tramadol HCl - 150mg 150mg Tablet, modified release 356,118 L.L
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