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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 - 30mg/ml 30mg/ml Injectable solution L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution 224,585,721 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 60mg/0.4ml 60mg/0.4ml Injectable solution 441,042,377 L.L
B01AB05 HEPAXANE 4000IU BioTech Enoxaparin sodium - 40mg/0.4ml 40mg/0.4ml Injectable solution 4,063,780 L.L
J05AF10 HEPCAVIR 0.5 G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 18,998,515 L.L
J05AF10 HEPCAVIR 1 G Entecavir monohydrate - 1mg 1mg Tablet, film coated 18,998,515 L.L
C03DA04 HEPERONA 25 G Eplerenone - 25mg 25mg Tablet, coated 2,116,552 L.L
C03DA04 HEPERONA 50 G Eplerenone - 50mg 50mg Tablet, coated 2,150,148 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution 38,083,434 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable freeze dried substance+diluent 2,490,140 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 940,690 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 33,852,747 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 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
L01BC05 HAXANIT G Gemcitabine (HCl) - 1g 1g Injectable lyophilised powder 6,829,408 L.L
L01BC05 HAXANIT G Gemcitabine (HCl) - 200mg 200mg Injectable lyophilised powder 1,411,035 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
N05AD01 HALOPERIDOL G Haloperidol - 10mg 10mg Tablet 339,160 L.L
N05AD01 HALOPERIDOL G Haloperidol - 20mg 20mg Tablet 339,160 L.L
N05AD01 HALOPERIDOL G Haloperidol - 2mg 2mg Tablet 252,130 L.L
N05AD01 HALDOL B Haloperidol - 5mg 5mg Tablet 231,141 L.L
N05AD01 HALOPERIDOL G Haloperidol - 5mg 5mg Tablet 276,448 L.L
B01AB01 HEPARINE SODIQUE PANPHARMA G Heparin sodium - 25,000IU/5ml 25,000IU/5ml Injectable solution 6,134,641 L.L
B01AB01 HEPARINE MEDIS G Heparin sodium - 25,000UI/5ml 25,000UI/5ml Injectable solution 6,853,597 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 0.5ml/dose 0.5ml/dose Injectable suspension 1,777,904 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 1ml/dose 0.5ml/dose Injectable suspension 2,257,655 L.L
J07BC02 HAVRIX '1440' B Hepatitis A, inactivated, whole virus - 1,440 ELISA units/ml 1,440 ELISA units/ml Injectable suspension 2,215,996 L.L
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