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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
J01XA01 VANCOLON G Vancomycin (HCl) - 0.5g 0.5g Injectable lyophilised powder for solution 1,009,226 L.L
L01AX03 TEMOZOLOMIDE PHARMINICIO G Temozolomide - 250mg 250mg Capsule, hard 12,058,004 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
M01AE03 SOLKET G Ketoprofen Lysine salt - 80mg 80mg Powder for solution 636,981 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
N03AX18 TREPADIO G Lacosamide - 50mg 50mg Tablet, film coated 606,073 L.L
N06AB06 PMS-SERTRALINE G Sertraline HCl - 100mg 100mg Capsule 2,015,764 L.L
R02A ALFA-AMYLASE BGR CONSEIL G Alpha-Amylase - 3,000U.CEIP 3,000U.CEIP Tablet, coated 290,270 L.L
A03AA04 BEVACOL 135 G Mebeverine HCl - 135mg 135mg Tablet, film coated 532,162 L.L
A10BA02 DIALON G Metformin HCl - 850mg 850mg Tablet 98,101 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 3,985,356 L.L
C07AB07 BISOPROLOL QUIVER LAB G Bisoprolol fumarate - 5mg 5mg Tablet, film coated, scored 264,737 L.L
C10BA05 OTOREZA 10/10 G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 454,219 L.L
J01DD04 AXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 4,047,654 L.L
J01XA01 VANCOMYCIN HIKMA G Vancomycin (HCl) - 500mg 500mg Injectable powder for solution 998,475 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
M01AE03 SOLKET INFLAMMATION AND PAIN G Ketoprofen Lysine salt - 0.16% 0.16% Spray 946,065 L.L
N06AB06 SERTRA TAD G Sertraline HCl - 100mg 100mg Tablet, film coated 1,124,796 L.L
R06AX13 APOTHECARE LORATADINE G Loratadine - 10mg 10mg Tablet 430,030 L.L
A03AA05 NEWBUTIN SR G Trimebutine maleate - 300mg 300mg Tablet, film coated, sustained release 1,654,270 L.L
A10BA02 DIANORM 850 G Metformin HCl - 850mg 850mg Tablet, film coated 221,286 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 5,566,628 L.L
C07AB07 BISOPROLOL REF G Bisoprolol hemifumarate - 5mg 5mg Tablet, coated, scored 272,800 L.L
C09DA04 ANDARAN PLUS G Irbesartan - 150mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 598,051 L.L
J01DD04 AXONE 1G IM G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution+diluent 438,093 L.L
J01XA01 VANCOMYCINE VIATRIS 500MG G Vancomycin - 500mg 500mg Injectable dry powder for solution 885,115 L.L
L01AX03 TEGOZOL G Temozolomide - 100mg 100mg Capsule 5,005,813 L.L
L04AA27 LYXIA G Fingolimod Hydrochloride - 0.25mg 0.5mg Capsule, hard 32,406,715 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 100mg 100mg Tablet 4,856,647 L.L
N06AB06 SOLOTIK G Sertraline HCl - 100mg 100mg Tablet, film coated 616,824 L.L
    ...
    134
    ...
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