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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
L01FX24 TECVAYLI BioTech Teclistamab - 10mg/ml 10mg/ml Injectable solution 95,166,436 L.L
S01LA04 LUCENTIS BioTech Ranibizumab - 10mg/ml 10mg/ml Injectable solution 51,255,093 L.L
L01CD04 CABAZITAXEL EVER PHARMA G Cabazitaxel - 60mg/6ml 10mg/ml Injectable concentrate for solution 54,531,485 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 100mg/10ml 10mg/ml Injectable solution 5,872,592 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 50mg/5ml 10mg/ml Injectable solution 5,305,490 L.L
D08AX01 EAU OXYGENEE 10/120 G Hydrogen peroxide - 10V 10V Solution 119,026 L.L
L02AE04 DECAPEPTYL LP B Triptorelin (pamoate) - 11.25mg 11.25mg Injectable powder for suspension+diluent 31,761,098 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
D11AX16 FLOREXA G Eflornithine (HCl) - 11.5% 11.5% Cream 3,527,587 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 1,603,204 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 3,205,064 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 2,576,338 L.L
L04AA29 XELJANZ XR B Tofacitinib - 11mg 11mg Tablet, extended release 78,687,316 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
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
C07AG02 CARVEDILOL ARROW G Carvedilol - 12.5mg 12.5mg Tablet, film coated, scored 364,181 L.L
N02CC05 ALMOVITAE G Almotriptan - 12.5mg 12.5mg Tablet, film coated 1,148,985 L.L
M01AB05 CLOREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 353,239 L.L
M01AB05 DICLOGESIC 12.5 CHILDREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 83,318 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,399,653 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,399,653 L.L
B01AC17 TIROPREST G Tirofiban - 12.5mg/50ml 12.5mg/50ml Injectable concentrate for solution 18,279,605 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,287,711 L.L
A10BX16 MOUNJARO KWIKPEN B Tirzepatide - 12.5mg/dose 12.5mg/dose Injectable solution 39,601,065 L.L
B01AC27 UPTRAVI B Selexipag - 1200mcg 1200mcg Tablet, film coated 275,097,581 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1200mg 1200mg Injectable concentrate for solution 375,054,619 L.L
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