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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution L.L
A07EC02 PENTASA XTEND B Mesalazine - 2g 2g Granules for suspension 8,550,789 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 500mg 500mg Tablet, film coated 908,603 L.L
L01EX03 VOTRIENT B Pazopanib HCl - 200mg 200mg Tablet, film coated 42,465,160 L.L
L04AA37 OLUMIANT B Baricitinib - 4mg 4mg Tablet, film coated 68,053,864 L.L
R03AL11 BREZTRI AEROSPHERE B Formoterol fumarate dihydrate - 5mcg, Glycopyrronium Bromide - 7.2mcg, Budesonide - 160mcg Inhalation suspension 6,705,774 L.L
A07EC02 ASACOL B Mesalazine - 500mg 500mg Suppository 1,703,992 L.L
A10BX02 NOVONORM B Repaglinide - 2mg 2mg Tablet 666,546 L.L
C10AA07 CRESTOR B Rosuvastatin (calcium) - 10mg 10mg Tablet, film coated 804,962 L.L
D10AD04 ROACCUTANE B Isotretinoin - 0.05% 0.05% Gel 932,627 L.L
G04BE30 LIF-DOL B Yohimbin HCl - 3.3mg, Thiamine - 5.5mg, Cyanocobalamine - 0.015mg, Ferrous fumarate - 50mg, Sildenafil citrate - 10mg Tablet, coated 231,653 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated 262,387,816 L.L
L04AA42 MAYZENT B Siponimod - 0.25mg 0.25mg Tablet, film coated 15,102,158 L.L
R03BA01 CLENIL 250 MCG SPRAY B Beclometasone dipropionate - 250mcg/actuation 250mcg/actuation Inhalation solution 1,166,455 L.L
L04AD02 PROGRAF 0.5 MG B Tacrolimus - 0.5mg 0.5mg Capsule L.L
A07EC02 SALOFALK 500 B Mesalazine - 500mg 500mg Suppository 677,297 L.L
C03EA01 MODURETIC B Hydrochlorothiazide - 50mg, Amiloride HCl - 5mg Tablet 767,985 L.L
C09CA04 APROVEL B Irbesartan - 300mg 300mg Tablet, film coated 651,764 L.L
D10AD06 AKLIEF B Trifarotene - 50mcg/g 50mcg/g Cream 4,359,425 L.L
G04BX ROWATINEX B Olive oil - 33mg, Cineol - 3mg, Fenchone - 4mg, Anethol - 4mg, Borneol - 10mg, Camphene - 15mg, ?-Pinene - 6.2mg, ?-Pinene - 24.8mg Capsule 255,330 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01EX07 CABOMETYX B Cabozantinib - 20mg 20mg Tablet, film coated 424,098,997 L.L
L04AA42 MAYZENT B Siponimod - 0.25mg 0.25mg Tablet, film coated 124,258,444 L.L
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule L.L
A10BX02 NOVONORM B Repaglinide - 0.5mg 0.5mg Tablet 475,720 L.L
C09CA04 APROVEL B Irbesartan - 300mg 300mg Tablet, film coated 651,764 L.L
G04BX14 PRILIGY B Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 1,957,979 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01EX07 CABOMETYX B Cabozantinib - 40mg 40mg Tablet, film coated 424,098,997 L.L
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