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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
J01AA02 DOXY 50 G Doxycycline (hyclate) - 50mg 50mg Tablet, coated 311,771 L.L
J01DH02 MEROPENEM PANPHARMA G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 7,278,513 L.L
J05AF07 TENOREAD G Tenofovir disoproxil fumarate - 300mg 300mg Tablet, film coated 7,129,777 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable concentrated solution 2,123,271 L.L
L01XX05 CUREAML G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 1,228,272 L.L
M01AB05 DICLO-DENK 50 G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 893,655 L.L
M05BA08 ZOLEDRO-DENK G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 4,388,990 L.L
N03AX11 TOPIRATE 25 BENTA G Topiramate - 25mg 25mg Tablet, film coated 671,921 L.L
P01AB01 METRIS G Metronidazole - 500mg/100ml 0.5% Injectable solution 142,447 L.L
R05DB13 RAPICOD G Butamirate citrate - 0.15% 0.15% Syrup 296,989 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,228,091 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
B01AC04 CERUVIN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 240,548 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 180,421 L.L
D05AX52 BETA-CAL G Calcipotriol (monohydrate) - 50mcg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 1,574,983 L.L
G03DA04 CYCLOGEST G Progesterone - 400mg 400mg Pessary 1,546,763 L.L
J01AA02 DOXY 100 G Doxycycline (hyclate) - 100mg 100mg Tablet, coated 788,836 L.L
J01DH02 MEROPENEM/ ANFARM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF07 TENVOR G Tenofovir disoproxil fumarate - 300mg 300mg Tablet, film coated 3,753,352 L.L
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
L01XX05 CYTODROX G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 3,301,821 L.L
M01AB05 DICLOGESIC G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 205,608 L.L
M05BA08 ZOLEDRONIC ACID ACCORD G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 7,028,741 L.L
N03AX11 TORAMAT G Topiramate - 25mg 25mg Tablet, film coated 522,755 L.L
P01AB01 METRONIDAZOLE G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,605 L.L
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 296,925 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
B01AC04 CLODOR G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 1,148,025 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 222,941 L.L
C01BD01 AMIODARONE BIOGARAN G Amiodarone (HCl) - 200mg 200mg Tablet 345,368 L.L
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