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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
A11DB 3V G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 198,889 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10000UI/ml 10000UI/ml Injectable solution 2,486,109 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 519,736 L.L
H02AB02 DEXAMEDIS FORT G Dexamethasone Phosphate - 8mg/2ml 8mg/2ml Injectable solution 43,003 L.L
L04AX03 METOJECT G Methotrexate disodium - 20mg/0.4ml 20mg/0.4ml Injectable solution 2,134,022 L.L
N07AA01 METHYL SULFATE DE NEOSTIGMINE RENAUDIN G Neostigmine methyl sulfate - 0.5mg/ml 0.5mg/ml Injectable solution 467,657 L.L
A11DB TRILAGAVIT G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 579,196 L.L
B03XA01 EPREX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU/ml 10,000IU/ml Injectable solution 37,968,085 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
H02AB02 DEXAMETHASONE SODIUM PHOSPHATE USP - EIPICO G Dexamethasone (sodium phosphate) - 8mg/2ml 8mg/2ml Injectable solution 185,450 L.L
L04AX03 METOJECT G Methotrexate disodium - 25mg/0.5ml 25mg/0.5ml Injectable solution 2,582,865 L.L
N02CD01 AIMOVIG BioTech Erenumab - 70mg/ml 70mg/ml Injectable solution 35,423,371 L.L
N07AA01 NEOSTIGMINE RENAUDIN G Neostigmine - 5mg/5ml 5mg/5ml Injectable solution 2,460,576 L.L
B03XA01 BINOCRIT BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU/ml 40,000IU/ml Injectable solution 11,726,826 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
H02AB02 DEXASINA G Dexamethasone Phosphate - 8mg/2ml 8mg/2ml Injectable solution 3,471,145 L.L
A11EA BECOZYME B Vitamin B5 - 6mg/2ml, Vitamin B6 - 4mg/2ml, Vitamin PP - 40mg/2ml, Vitamin B2 - 5.47mg/2ml, Vitamin B1 - 10mg/2ml Injectable solution 662,514 L.L
B03XA01 EPREX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU/ml 40,000IU/ml Injectable solution 13,250,926 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 166,708 L.L
H02AB02 RADOLINE G Dexamethasone sodium phosphate - 8mg/2ml 8mg/2ml Injectable solution 3,711,565 L.L
L01FG01 ZIRABEV BioTech Bevacizumab - 100mg/4ml 100mg/4ml Injectable solution 14,800,115 L.L
B03XA01 EPOTIN BioTech Erythropoietin recombinant human (Epoetin alfa) - 2,000IU 2,000IU Injectable solution 9,206,440 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 174,553 L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 100mg/10ml 100mg/10ml Injectable solution 47,779,251 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 1,198,595 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 8,728,144 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 188,772 L.L
H02AB02 DEXAMETHASON-PANPHARMA G Dexamethasone - 5mg/1ml 5mg/1ml Injectable solution 368,213 L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution 218,656,548 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 10,787,353 L.L
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