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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
N05CF02 STILNOX B Zolpidem (tartrate) - 10mg 10mg Tablet, film coated, scored 96,757 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 10mg 10mg Tablet, film coated 264,737 L.L
C10AA01 STAVINE G Simvastatin - 10mg 10mg Tablet 207,336 L.L
C10AA03 STAVACOR G Pravastatin sodium - 10mg 10mg Tablet, scored 1,695,801 L.L
G04BD08 SOLIFAS G Solifenacin succinate - 10mg 10mg Tablet, film coated 971,598 L.L
G04BD08 SOLIFENACINE ARROW G Solifenacin succinate - 10mg 10mg Tablet 952,784 L.L
C10AA05 STORVAS G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 362,837 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 575,270 L.L
D11AX22 SOOLANTRA B Ivermectin - 10mg/g 10mg/g Cream 2,154,180 L.L
D11AX22 SOOLANTRA B Ivermectin - 10mg/g 10mg/g Cream 1,053,573 L.L
D06BA01 SILVEDERMA G Silver sulfadiazine - 1% 10mg/g Cream 1,220,209 L.L
D06BA01 SILVEDERMA G Silver sulfadiazine - 1% 10mg/g Cream 494,534 L.L
N02BE01 SUPOFEN G Paracetamol - 10mg/ml 10mg/ml Injectable solution 7,675,286 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 12.5mg 12.5mg Capsule 36,042,560 L.L
L01EX01 SUNITINIB AQVIDA G Sunitinib maleate - 12.5mg 12.5mg Capsule, hard 38,073,237 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 12.5mg 12.5mg Tablet, controlled release 2,371,608 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,156,820 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,156,820 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,052,874 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 120mg 120mg Injectable solution 57,492,826 L.L
M04AA03 STABURIC G Febuxostat - 120mg 120mg Tablet, film coated 1,420,889 L.L
N02BE01 SULDEX 125 G Paracetamol - 125mg 125mg Suppository 110,067 L.L
J01DD15 SEFARIN G Cefdinir - 125mg/5ml 125mg/5ml Suspension 1,695,929 L.L
J01DD15 SEFARIN G Cefdinir - 125mg/5ml 125mg/5ml Suspension 939,346 L.L
D06BA05 SULFANILAMIDE G Sulfanilamide - 12g 12g Powder 151,022 L.L
L04AC05 STELARA BioTech Ustekinumab - 130mg 130mg Injectable concentrate for solution 226,619,295 L.L
B05XA05 SULFATE DE MAGNESIUM RENAUDIN G Magnesium sulfate - 1.5g/10ml 15% Injectable solution 434,061 L.L
N02BE01 SULDEX B G Paracetamol - 150mg 150mg Suppository 117,746 L.L
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