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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
B05D CAPD/DPCA 19Solution for peritoneal dialysis sleep safe G Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 22.73g/l, Fructose , - up to 1.1g/l Injectable solution 715,794 L.L
L04AB04 ADALIREL BioTech Adalimumab - 40mg 40mg Injectable solution 15,102,158 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 150mg/ml 150mg/ml Injectable solution 716,437,779 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) TWIN BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
L04AB04 CINNORA BioTech Adalimumab - 40mg/0.8ml 40mg/0.8ml Injectable solution 14,817,734 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 105mg/0.7ml 105mg/0.7ml Injectable solution 577,741,643 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) SINGLE BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 33,860,031 L.L
N02BE01 PARACEROL G Paracetamol - 10mg/ml 10mg/ml Injectable solution 1,536,012 L.L
B05DB DIANEAL PD4 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l 1.36% Injectable solution 1,163,270 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
N02BE01 SUPOFEN G Paracetamol - 10mg/ml 10mg/ml Injectable solution 7,675,286 L.L
N06BX06 SOMAZINA B Citicoline (sodium) - 1,000mg/4ml 1,000mg/4ml Injectable solution 787,492 L.L
R03DA05 AMINOPHYLLINE RENAUDIN G Aminophylline - 250mg/10ml 2.5% Injectable solution 739,113 L.L
B05DB DIANEAL PD4 CYCLER 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l Injectable solution 1,150,329 L.L
L01FC01 DARZALEX BioTech Daratumumab - 1800mg 1800mg Injectable solution 494,909,963 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
B05DB DIANEAL PD4 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,163,270 L.L
L04AB06 SIMPONI BioTech Golimumab - 50mg/0.5ml 50mg/0.5ml Injectable solution 72,719,241 L.L
B05DB DIANEAL PD4 CYCLER 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,150,329 L.L
L04AB06 SIMPONI BioTech Golimumab - 100mg/1ml 100mg/1ml Injectable solution 72,719,241 L.L
B05DB DIANEAL PD4 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,111,506 L.L
B05DB DIANEAL PD4 CYCLER 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,150,329 L.L
L04AC05 STELARA BioTech Ustekinumab - 45mg 45mg Injectable solution 151,777,679 L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution 151,777,679 L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
A10AB01 HUMULIN R U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 701,486 L.L
B05XA01 CHLORURE DE POTASSIUM RENAUDIN G Potassium chloride - 7.46g/100ml 7.46% Injectable solution 385,683 L.L
J01XB01 COLISTIN/NORMA G Colistimethate Sodium - 1MIU 1MIU Injectable solution 872,154 L.L
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