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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
B02BX06 HEMLIBRA BioTech Emicizumab - 150mg/ml 150mg/ml Injectable solution 716,437,779 L.L
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B05D CAPD/DPCA 19Solution for peritoneal dialysis stay 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 740,031 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
B05D CAPD/DPCA 2Solution for peritoneal dialysis stay safe G Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.2573g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 15g/l, Glucose monohydrate - 16.5g/l Injectable solution 707,716 L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution L.L
B05D CAPD/DPCA 3Solution for peritoneal dialysis G Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.2573g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 42.50g/l, Glucose monohydrate - 46.75g/l Injectable solution 740,031 L.L
B05D CAPD/DPCA 17Solution 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 - 15g/l, Fructose , - up to 0.75g/l Injectable solution 715,794 L.L
A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 L.L
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
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A10AB01 ACTRAPID BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 752,552 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
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
A10AB01 HUMULIN R U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 701,486 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
A10AB01 JUSLINE R BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 401,809 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
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg/250ml 400mg/250ml Injectable solution 9,052,935 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
A10AB04 HUMALOG KWIKPEN BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable solution 3,950,897 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
J01MA14 MOFLOXINE G Moxifloxacin (HCl) - 400mg/250ml 400mg/250ml Injectable solution 1,638,144 L.L
L04AB01 ALTEBREL BioTech Etanercept - 50mg/1ml 50mg/1ml Injectable solution 14,833,767 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 637,365 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
L04AB01 ENBREL BioTech Etanercept - 50mg 50mg Injectable solution 52,197,598 L.L
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