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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
P01AB01 ? METRONIDAZOL G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,541 L.L
B01AB05 PARINOX 40 BioTech Enoxaparin sodium - 4000IU (40mg)/0.4ml 4000IU (40mg)/0.4ml Injectable solution 358,358 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B01AB05 ENOMEX BioTech Enoxaparin sodium - 8000U Anti-Xa/0.8ml 8000U Anti-Xa/0.8ml Injectable solution 1,025,160 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 268,908 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE C G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.33g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 204.54g/l Injectable solution L.L
H05AA02 CINNOPAR BioTech Teriparatide - 250mcg/ml 250mcg/ml Injectable solution 15,275,833 L.L
M05BX04 PROLIA BioTech Denosumab - 60mg/ml 60mg/ml Injectable solution 21,603,638 L.L
A03FA01 CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 530,818 L.L
B01AB05 ENOXA MEDIS BioTech Enoxaparin sodium - 8,000U Anti-Xa/0.8ml 8,000U Anti-Xa/0.8ml Injectable solution 963,535 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 232,134 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE D G Potassium chloride - 5.215g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l Injectable solution L.L
H05AA02 FORTEO BioTech Teriparatide - 250mcg/ml 20mcg/80mcl Injectable solution 24,834,241 L.L
M05BX04 XGEVA BioTech Denosumab - 120mg 120mg Injectable solution 33,545,669 L.L
A03FA01 ELITAN G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 252,642 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 8000IU Anti-XA/0.8ml 8000IU Anti-XA/0.8ml Injectable solution 963,535 L.L
B05BB01 LR G Sodium lactate - 0.3g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE E G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 7.00g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 205.49g/l Injectable solution L.L
H05AA02 OSTEOFORTIL BioTech Teriparatide - 250mcg/ml 250mcg/ml Injectable solution 16,963,499 L.L
L01CE02 IRNOCAM 100 G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable solution 7,320,947 L.L
M05BX06 EVENITY BioTech Romosozumab - 105mg/1.17ml 105mg/1.17ml Injectable solution 56,729,091 L.L
A03FA01 METOCLOPRAMIDE S.A.L.F. G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 255,330 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 8000IU Anti-XA/0.8ml 8000IU Anti-XA/0.8ml Injectable solution 4,575,784 L.L
B05BB01 SERUFLEX 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 232,134 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE F G Potassium chloride - 3.914g/l, Magnesium chloride, 6H2O - 3.558g/l, Calcium chloride, 2H2O - 7.719g/l, Acetic acid 100% - 6.010ml/l, Sodium chloride - 208.631g/l Injectable solution L.L
H05BA01 MIACALCIC B Calcitonin (salmon synthetic) - 100IU/ml 100IU/ml Injectable solution 1,720,118 L.L
A03FA01 METORAM G Metoclopramide HCl - 10mg/2ml 10mg/2ml Injectable solution 421,071 L.L
B01AB05 LOVENOX BioTech Enoxaparin sodium - 8000UI (80mg)/0.8ml 8000UI (80mg)/0.8ml Injectable solution 1,206,771 L.L
B05BB01 SOLUFLEX 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 264,311 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE SG G Potassium chloride - 3.92g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l Injectable solution L.L
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