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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
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
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
D07AA02 HYDROCORTISONE ACETATE G Hydrocortisone acetate - 1% 1% Cream 215,015 L.L
J01DB04 HIKMA CEFAZOLIN G Cefazolin (sodium) - 1g 1,000mg Injectable solution 215,015 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
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable freeze dried substance+diluent 2,490,140 L.L
A11CC05 HI DEE G Vitamin D3 - 10000IU 10000IU Capsule, soft gelatin 862,747 L.L
A10AB01 HUMULIN R U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable solution 701,486 L.L
A10AB04 HUMALOG KWIKPEN BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable solution 3,950,897 L.L
A10AB04 HUMALOG BioTech Insulin lispro - 100IU/ml 100IU/ml Injectable suspension 1,988,887 L.L
A10AD01 HUMULIN 70/30 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A10AD04 HUMALOG MIX 50 KWIKPEN BioTech Insulin lispro solution - 50%, Insulin lispro protamine suspension - 50% 100IU/ml Injectable suspension 3,950,897 L.L
A10AD04 HUMALOG MIX 25 KWIKPEN BioTech Insulin lispro solution - 25%, Insulin lispro protamine suspension - 75% 100IU/ml Injectable suspension 3,950,897 L.L
A10AE01 HUMULIN N U-100 BioTech Insulin (human) - 100IU/ml 100IU/ml Injectable suspension 701,486 L.L
A07XA04 HIDRASEC B Racecadotril - 100mg 100mg Capsule, hard 411,216 L.L
H02AB09 HYDROCORTISON VUAB G Hydrocortisone hydrogenosuccinate - 100mg 100mg Injectable dry powder for solution 147,823 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
M01AE03 HUMFINE G Ketoprofen - 100mg/2ml 100mg/2ml Injectable solution 3,514,148 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 105mg/0.7ml 105mg/0.7ml Injectable solution 577,741,643 L.L
J07BC01 HEPATITIS-B VACCINE (r DNA) PAEDIATRIC G Hepatitis B, purified surface antigen adsorbed on aluminium hydroxide (Al+++) (0.25mg to 0.40mg) - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 323,866 L.L
N05AD01 HALOPERIDOL G Haloperidol - 10mg 10mg Tablet 339,160 L.L
A07XA04 HIDRASEC INFANTS B Racecadotril - 10mg 10mg Granules for suspension 858,715 L.L
H02AB09 HYDROCORTISONE ROUSSEL B Hydrocortisone - 10mg 10mg Tablet, scored 260,705 L.L
A07EA02 HEMORRANE G Hydrocortisone acetate - 10mg/g 10mg/g Ointment 710,893 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 150mg 150mg Injectable powder for concentrate for solution 36,062,671 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 150mg/ml 150mg/ml Injectable solution 716,437,779 L.L
H01AC01 HHT BioTech Somatropin recombinant - 16IU (5.32mg) 16IU (5.32mg) Injectable freeze dried powder + diluent 4,078,562 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution 39,933,692 L.L
L01AA06 HOLOXAN B Ifosfamide - 1g 1g Injectable powder for solution 3,586,850 L.L
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