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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
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
B01AB01 HEPARINE MEDIS G Heparin sodium - 25,000UI/5ml 25,000UI/5ml Injectable solution 6,853,597 L.L
B01AB01 HEPARINE SODIQUE PANPHARMA G Heparin sodium - 25,000IU/5ml 25,000IU/5ml Injectable solution 6,134,641 L.L
B01AB05 HEPAXANE 4000IU BioTech Enoxaparin sodium - 40mg/0.4ml 40mg/0.4ml Injectable solution 4,063,780 L.L
M09AX01 HYALGAN B Hyaluronic acid (sodium) - 20mg/2ml 20mg/2ml Injectable solution 3,407,985 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution 38,083,434 L.L
B01AB12 HIBOR G Bemiparin Sodium - 2,500IU 2,500IU Injectable solution 704,173 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
B01AB12 HIBOR G Bemiparin Sodium - 7,500IU 7,500IU Injectable solution 2,198,526 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
B05BB02 HI-SODIUM WITHOUT POTASSIUM INJECTION G Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 166,708 L.L
B05BB02 HI-SODIUM INJECTION G Sodium lactate - 0.223g%, Sodium dihydrogenophosphate - 0.137g%, Potassium chloride - 0.149g%, Sodium chloride - 0.175g%, Dextrose, H2O - 5.0g% Injectable solution 176,024 L.L
B05BB02 HI-SODIUM INJECTION WITH POTASSIUM G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
J06BA02 HIZENTRA 1G BioHuman Immunoglobulin human - 1g/5ml 20% Injectable solution 9,246,433 L.L
J06BA02 HIZENTRA 2G BioHuman Immunoglobulin human - 2g/10ml 20% Injectable solution 17,658,835 L.L
J06BA02 HIZENTRA 4G BioHuman Immunoglobulin human - 4g/20ml 20% Injectable solution 35,323,423 L.L
M01AE03 HUMFINE G Ketoprofen - 100mg/2ml 100mg/2ml Injectable solution 3,514,148 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution 39,933,692 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 2g 2g Injectable powder for solution 73,094,026 L.L
L01AA06 HOLOXAN B Ifosfamide - 1g 1g Injectable powder for solution 3,586,850 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 440mg 440mg Injectable powder for concentrate for solution 89,046,707 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 150mg 150mg Injectable powder for concentrate for solution 36,062,671 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 600IU, Blood Coagulation Factor VIII - 250IU Injectable lyophilised powder for solution+diluent 14,117,737 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 2400IU, Blood Coagulation Factor VIII - 1000IU Injectable lyophilised powder for solution+diluent 49,643,758 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent 33,698,319 L.L
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