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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
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
M09AX01 HYALGAN B Hyaluronic acid (sodium) - 20mg/2ml 20mg/2ml Injectable solution 3,407,985 L.L
A03FA01 METORAM G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 3,026,845 L.L
B01AB05 PARINOX 80 BioTech Enoxaparin sodium - 8000IU (80mg)/0.8ml 8000IU (80mg)/0.8ml Injectable solution 494,022 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 129,934 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS L 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-:106.5 mmol/l, Sodium chloride - Na+:135 mmol/l Injectable solution L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution 38,083,434 L.L
N05BA01 DIAZEPAM RENAUDIN G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 514,692 L.L
A03FA01 VOMICARE INJECTION BP IM/IV G Metoclopramide - 10mg/2ml 10mg/2ml Injectable solution 247,267 L.L
B01AB05 ENOMEX BioTech Enoxaparin sodium - 6000U Anti-Xa/0.6ml 6000U Anti-Xa/0.6ml Injectable solution 922,772 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
N05BA01 KRATIUM G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 537,537 L.L
B01AB05 ENOXA MEDIS BioTech Enoxaparin sodium - 6,000U Anti-Xa/0.6ml 6,000U Anti-Xa/0.6ml Injectable solution 765,990 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
L01DB01 DOXO-CELL G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 1,794,030 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 6000IU Anti-XA/0.6ml 6000IU Anti-XA/0.6ml Injectable solution 765,990 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 6000IU Anti-XA/0.6ml 6000IU Anti-XA/0.6ml Injectable solution 3,637,782 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 154,450 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
B01AB05 ENOXAPARIN LEDRAXEN BioTech Enoxaparin sodium - 6000UI (60mg)/0.6ml 6000UI (60mg)/0.6ml Injectable solution 854,684 L.L
B05BB01 R-SOL 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 R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
M01AB05 ALMIRAL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 415,247 L.L
N01AH01 FENTANYL PANPHARMA G Fentanyl - 0.1mg/2ml 0.1mg/2ml Injectable solution 1,101,951 L.L
B01AB05 LOVENOX BioTech Enoxaparin sodium - 6000UI (60mg)/0.6ml 6000UI (60mg)/0.6ml Injectable solution 1,085,825 L.L
B05BB01 SERUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
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