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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
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 46,817,511 L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent 23,067,288 L.L
J07BD52 PRIORIX B Rubella virus live attenuated - ?10³ CCID50, Mumps virus live attenuated - ?103.7 CCID50, Measles virus live attenuated - ?10³ CCID50 Injectable lyophilised powder for solution+diluent 1,142,266 L.L
B02BD04 IMMUNINE BioHuman Plasma coagulation factor IX, human - 600IU 600IU Injectable lyophilised powder for solution+diluent 20,506,214 L.L
J07BK01 VARILRIX + SOLVENT IN SYRINGE B Varicella virus, live attenuated - ?1033 PFU ?1033 PFU Injectable lyophilised powder for solution+diluent 3,473,833 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
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent L.L
J01DD01 CEFOTAX G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 217,702 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent L.L
J01DD01 STOPAREN G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 213,671 L.L
J01DD04 ROCEPHIN IV B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 757,927 L.L
J01DD04 ROCEPHIN IM B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 731,050 L.L
J01XA02 TARGOCID B Teicoplanin - 400mg 400mg Injectable lyophilised powder for solution+diluent 1,331,748 L.L
J01XA02 TARGOCID B Teicoplanin - 200mg 200mg Injectable lyophilised powder for solution+diluent 714,924 L.L
H01AB01 THYROGEN BioHuman Thyrotropin alfa - 0.9mg 0.9mg Injectable lyophilised powder for solution+diluent 65,558,997 L.L
J01DD04 CEFAXONE IV G Ceftriaxone - 1g 1g Injectable lyophilised powder for solution+diluent 403,153 L.L
J01DD04 TRAVILAN IM G Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 438,093 L.L
J01DD04 VERACOL G Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 454,219 L.L
H01CC02 CETROTIDE B Cetrorelix (acetate) - 0.25mg 0.25mg Injectable lyophilised powder for solution+diluent 3,420,079 L.L
H01CC02 CETROTIDE B Cetrorelix (acetate) - 0.25mg 0.25mg Injectable lyophilised powder for solution+diluent 21,354,452 L.L
H01CC02 CETROTIDE B Cetrorelix (acetate) - 0.25mg 0.25mg Injectable lyophilised powder for solution+diluent 21,354,452 L.L
H01CC02 CETROTIDE B Cetrorelix (acetate) - 0.25mg 0.25mg Injectable lyophilised powder for solution+diluent 3,420,079 L.L
R03DX05 XOLAIR BioTech Omalizumab - 150mg 150mg Injectable lyophilised powder for solution+diluent 52,297,174 L.L
H02AB09 SOLU CORTEF ACT-O-VIAL B Hydrocortisone (sodium succinate) - 250mg 250mg Injectable lyophilised powder for solution+diluent 421,967 L.L
N03AG01 DEPAKINE B Sodium Valproate - 400mg 400mg Injectable lyophilised powder for solution+diluent 450,187 L.L
G03GA01 CHORIOMON BioHuman Human Chorionic Gonadotrophin - 5,000IU 5,000IU Injectable lyophilised powder for solution+diluent 4,031,528 L.L
G03GA04 FOSTIMON BioHuman Urofollitropin - 150IU 150IU Injectable lyophilised powder for solution+diluent 36,347,120 L.L
L02AE04 DECAPEPTYL B Triptorelin - 0.1mg 0.1mg Injectable lyophilised powder for solution+diluent 2,366,507 L.L
    ...
    139
    ...
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