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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
M01AB05 CLOFEN G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 299,677 L.L
N01AH01 FENTANYL HAMELN G Fentanyl (citrate) - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,206,771 L.L
N03AX12 GABANET 400 G Gabapentin - 400mg 400mg Capsule 1,607,236 L.L
N05BA08 ANXYL G Bromazepam - 3mg 3mg Tablet, scored 167,660 L.L
A03FA03 NAUZEX G Domperidone - 10mg 10mg Tablet 258,530 L.L
A10BB12 GLUMYL 3 G Glimepiride - 3mg 3mg Tablet 511,940 L.L
B05BB01 SOLUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 221,792 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+ G Hemodialytics, concentrates - Injectable solution L.L
C08CA01 AMLODIPINE BIOGARAN G Amlodipine (besylate) - 10mg 10mg Capsule 462,282 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 10mg Capsule, hard 1,368,032 L.L
G03DA04 CYCLOGEST G Progesterone - 400mg 400mg Pessary 1,546,763 L.L
J01AA02 GRANUDOXY G Doxycycline (monohydrate) - 100mg 100mg Tablet, film-scored 282,207 L.L
J01DH03 ERTANZ G Ertapenem - 1g 1g Injectable powder 2,521,049 L.L
J05AF10 APO-ENTECAVIR G Entecavir - 0.5mg 0.5mg Tablet 28,943,287 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 10mg/5ml 10mg/5ml Injectable solution 822,636 L.L
M01AB05 DICLOCELL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 945,809 L.L
N01AH01 FENTANYL MEDIS G Fentanyl (citrate) - 0.5mg/10ml 0.5mg/10ml Injectable solution 1,190,644 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 400mg 400mg Capsule 1,342,499 L.L
A03FA03 NOVADOM G Domperidone - 10mg 10mg Tablet 278,175 L.L
A10BB12 GLYPRIDE G Glimepiride - 3mg 3mg Tablet 571,133 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 180,421 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE J G Hemodialytics, concentrates - Injectable solution L.L
C08CA01 AMLOKEY G Amlodipine (besylate) - 10mg 10mg Tablet 397,777 L.L
C09DX LOSANET AM PLUS G Losartan potassium - 100mg, Amlodipine - 10mg, Hydrochlorothiazide - 12.5mg Tablet 1,044,358 L.L
G03DA04 GESTA 400 G Progesterone - 400mg 400mg Pessary 1,083,137 L.L
J01AA02 GRANUDOXY G Doxycycline (monohydrate) - 100mg 100mg Tablet, film-scored 282,207 L.L
J01DH03 ERTAPENEM INJECTION G Ertapenem - 1g 1g Injectable concentrate for solution 26,153,163 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 32,224,230 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 3,765,140 L.L
M01AB05 DICLO-DENK 75 INJECTION G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 716,268 L.L
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