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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
V03AE01 RESINSODIO G Sodium polystyrene sulphonate - 99.75g/100g 99.75g/100g Powder for suspension 1,534,668 L.L
A03FA01 VOMICARE INJECTION BP IM/IV G Metoclopramide - 10mg/2ml 10mg/2ml Injectable solution 247,267 L.L
A10BB12 JOSWE GLEMAX 2 G Glimepiride - 2mg 2mg Caplet 326,554 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LM G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 LUSTRA G Amlodipine - 5mg 5mg Tablet 485,127 L.L
C09DB07 CANDAM G Candesartan cilexetil - 8mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
D04AA32 HISTERGAN G Diphenhydramine HCl - 2% 2% Cream 546,944 L.L
J01DH02 MEROPENEM PANPHARMA G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 7,278,513 L.L
J05AF07 TENVOR G Tenofovir disoproxil fumarate - 300mg 300mg Tablet, film coated 3,753,352 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 10mg/5ml 10mg/5ml Injectable concentrated solution 428,686 L.L
M01AB05 OLFEN-100 SR G Diclofenac sodium - 100mg 100mg Capsule, prolonged release 503,941 L.L
N01AB06 ISOFLURANE HIKMA G Isoflurane - Volatil liquid 1,583,046 L.L
N03AX12 GABATREX G Gabapentin - 300mg 300mg Capsule 1,585,734 L.L
N05BA01 KRATIUM G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 537,537 L.L
P01AB07 SNAD G Secnidazole - 500mg 500mg Tablet 774,053 L.L
R05X COLDIN G Glyceryl guaiacolate - 15mg/5ml, Pseudoephedrine HCl - 15mg/5ml, Pyrilamine maleate - 6.25mg/5ml, Paracetamol - 120mg/5ml Syrup 386,515 L.L
A10BB12 ORBIDE G Glimepiride - 2mg 2mg Tablet 209,895 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 224,565 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:111.5 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 TORANS G Amlodipine (besylate) - 5mg 5mg Tablet 518,339 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 5mg Capsule, hard 1,368,032 L.L
D04AA32 HISTAFEN G Diphenhydramine HCl - 2% 2% Solution 362,837 L.L
J01DH02 MEROPENEM/ ANFARM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 1mg 1mg Tablet, film coated 31,285,380 L.L
L01DB01 DOXO-CELL G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 1,794,030 L.L
M01AB05 TRATUL RETARD G Diclofenac Sodium - 100mg 100mg Tablet, film coated 866,778 L.L
N03AX12 NEUROPLEX G Gabapentin - 300mg 300mg Capsule 1,107,326 L.L
N05BA02 PSICODEX G Chlordiazepoxide - 5mg 5mg Tablet 152,302 L.L
P01AB07 SECNOL G Secnidazole anhydre - 2g 2g Granules 842,589 L.L
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