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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
M05BA08 ZOLEDRONIC ACID HIKMA G Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrate for solution 9,098,466 L.L
N03AX11 TOPIRATE 50 BENTA G Topiramate - 50mg 50mg Tablet, film coated 1,407,835 L.L
P01AB01 METRONIDAZOLE PANPHARMA G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 1,624,706 L.L
V03AC03 ENFEROX G Deferasirox - 500mg 500mg Tablet, dispersible 37,720,158 L.L
A03CA02 PRIMAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 L.L
A10BB12 AMEPRIDE G Glimepiride - 1mg 1mg Tablet 137,072 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.02g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 239,275 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 10g/100ml 10g/100ml Injectable solution 5,040,303 L.L
C08CA01 AMLOCARD G Amlodipine (besylate) - 5mg 5mg Tablet 473,545 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable sterile lyophilised powder for solution 995,723 L.L
J05AB14 VAGLONAX G Valganciclovir (HCl) - 450mg 450mg Tablet, film coated 49,858,549 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 3,246,979 L.L
N03AX11 TORAMAT G Topiramate - 50mg 50mg Tablet, film coated 1,032,071 L.L
P01AB01 METRONOR G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 5,359,244 L.L
V03AC03 DEFERASIROX ARROW G Deferasirox - 90mg 90mg Tablet 8,846,092 L.L
A03CA02 ULCEDEX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 L.L
A10BB12 DIAMERIL G Glimepiride - 1mg 1mg Tablet 130,545 L.L
B05BB01 LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 216,046 L.L
B05XA07 CALCIUM CHLORIDE G Calcium chloride - 10g/100ml 10g/100ml Injectable solution 5,436,771 L.L
C08CA01 AMLOCOEUR G Amlodipine - 5mg 5mg Tablet 362,198 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable sterile lyophilised powder for solution 19,022,727 L.L
J05AB14 VALGANCICLOVIR ARROW G Valganciclovir (HCl) - 450mg 450mg Tablet, coated 44,309,215 L.L
L01CE01 TOPOTU G Topotecan HCl - 4mg/4ml 4mg/4ml Injectable concentrated solution 7,253,796 L.L
M01AB05 OLFEN-50 G Diclofenac sodium - 50mg 50mg Tablet, gastroresistant 248,611 L.L
M05BA08 SIMPLA G Zoledronic acid - 5mg/100ml 5mg/100ml Injectable solution 13,071,402 L.L
N05AX15 REAGILA G Cariprazine HCl - 1.5mg 1.5mg Capsule, hard 6,394,003 L.L
P01AB01 POLGYL G Metronidazole - 0.5% 0.5% Injectable solution 134,384 L.L
V03AC03 DEFEROXAL 90 G Deferasirox - 90mg 90mg Tablet, film coated 9,279,724 L.L
A10BB12 GLIM G Glimepiride - 1mg 1mg Tablet 302,365 L.L
B05BB01 LR G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 218,681 L.L
    ...
    139
    ...
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