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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
D11AH02 ELIDEL B Pimecrolimus - 10mg/g 1% Cream 1,780,591 L.L
D01AC03 ECONAZ G Econazole nitrate - 1% 1% Cream 307,164 L.L
D01AE22 EXODERIL B Naftifine HCl - 10mg/g 1% Cream 345,368 L.L
D01AE22 EXODERIL B Naftifine HCl - 10ml/ml 1% Solution 159,917 L.L
D10AF02 ERYTHROMYCIN 1.5 % G Erythromycin - 15mg/ml 1.5 % Solution 501,701 L.L
A12BA01 EURO-K G Potassium chloride - 1.5g 1.5g Tablet, sustained release 894,999 L.L
A11CC05 EURO D 10000 IU G Vitamin D3 - 10,000IU 10,000IU Capsule 993,100 L.L
L01XX02 ERWINASE BioTech Erwinia L-asparaginase - 10,000IU 10,000IU Injectable lyophilised powder for solution 444,434,845 L.L
B03XA01 EPREX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU/ml 10,000IU/ml Injectable solution 37,968,085 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 10000IU Anti-XA/1ml 10000IU Anti-XA/1ml Injectable solution 1,209,458 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10000UI/ml 10000UI/ml Injectable solution 2,486,109 L.L
B02BD02 ESPEROCT BioTech Turoctocog Alfa pegol (recombinant coagulation factor VIII) - 1000IU/Vial 1000IU/Vial Injectable powder for solution+diluent 72,849,268 L.L
H03AA01 ELTROXIN B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 440,780 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 100mcg 100mcg Tablet, scored 452,875 L.L
G03GA09 ELONVA BioHuman Corifollitropin alfa - 100mcg/0.5ml 100mcg/0.5ml Injectable solution 35,131,802 L.L
L01FD04 ENHERTU BioTech Trastuzumab deruxtecan - 100mg 100mg Injectable powder for concentrate for solution 178,517,964 L.L
N03AB02 EPANUTIN B Phenytoin sodium - 100mg 100mg Capsule 739,113 L.L
J02AX06 ECALTA B Anidulafungin - 100mg 100mg Injectable concentrated powder for solution 16,977,343 L.L
G03DA04 ENDOMETRIN B Progesterone - 100mg 100mg Tablet 2,776,379 L.L
L01FE01 ERBITUX BioTech Cetuximab - 100mg/20ml 100mg/20ml Injectable solution L.L
L01FE01 ERBITUX BioTech Cetuximab - 100mg/20ml 100mg/20ml Injectable solution 24,001,769 L.L
L01CB01 ETOPOSIDE EBEWE G Etoposide - 100mg/5ml 100mg/5ml Injectable concentrated solution 768,678 L.L
L01CB01 ETOPOSIDE VIATRIS 20MG/ML G Etoposide - 100mg/5ml 100mg/5ml Injectable concentrated solution 1,485,634 L.L
M05BX06 EVENITY BioTech Romosozumab - 105mg/1.17ml 105mg/1.17ml Injectable solution 56,729,091 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 108mg 108mg Injectable solution 88,955,869 L.L
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
L01EG02 EVEROLIMUS ARROW G Everolimus - 10mg 10mg Tablet 88,257,720 L.L
L01EG02 EVEROLIMUS BIOGARAN G Everolimus - 10mg 10mg Tablet 124,701,632 L.L
A10BK03 EMPAZA G Empagliflozin - 10mg 10mg Tablet, film coated 1,740,724 L.L
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