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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
L01FX24 TECVAYLI BioTech Teclistamab - 90mg/ml 90mg/ml Injectable solution 483,720,518 L.L
B06AC05 TAKHZYRO BioTech Lanadelumab - 300mg/2ml Injectable solution 1,204,227,927 L.L
C09BA05 TRILTEC PLUS G Ramipril - 10mg, Hydrochlorothiazide - 12.5mg Tablet 2,243,577 L.L
C09BA05 TRILTEC PLUS G Ramipril - 5mg, Hydrochlorothiazide - 12.5mg Tablet 2,189,823 L.L
C10AA05 TARDELIP G Atorvastatin - 10mg 10mg Tablet, film coated 688,559 L.L
C10AA05 TARDEN G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 688,559 L.L
C10AA05 TORVACOL 10 G Atorvastatin (calcium) - 10mg 10mg Tablet, coated 1,128,828 L.L
L01EB02 TARESSA 100 G Erlotinib (HCl) - 100mg 100mg Tablet, film coated 82,247,256 L.L
C10AA05 TORVALIP 10 G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 767,910 L.L
C10AA05 TOVAST G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,127,484 L.L
C02CA06 TACHYBEN G Urapidil - 25mg/5ml 25mg/5ml Injectable solution 1,439,255 L.L
C10AA05 TULIP G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 899,031 L.L
L01EB02 TARESSA 150 G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 98,617,813 L.L
G04BE03 TOURNES G Sildenafil - 50mg 50mg Tablet 956,386 L.L
R01AD08 TICANASE G Fluticasone propionate - 50mcg/actuation 12g/Bottle Spray, suspension 405,840 L.L
C02KX01 TRACTAN G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 47,747,570 L.L
L02BX03 TEROPROS G Abiraterone acetate - 500mg 500mg Tablet, film coated 45,489,064 L.L
C02KX01 TRACTAN G Bosentan (monohydrate) - 62.5mg 62.5mg Tablet, film coated 47,747,570 L.L
R01AD09 TABUNEX G Mometasone furoate - 0.05% 0.05% Spray 419,279 L.L
G04BE03 TOURNES G Sildenafil - 100mg 100mg Tablet 1,531,656 L.L
C10AA05 TARDELIP G Atorvastatin - 20mg 20mg Tablet, film coated 880,537 L.L
C10AA05 TARDEN G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 880,537 L.L
C10AA05 TORVACOL 20 G Atorvastatin (calcium) - 20mg 20mg Tablet, coated 1,128,828 L.L
C10AA05 TORVALIP 20 G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 972,686 L.L
D07CC01 TOPIZONE G Fusidic acid - 20mg/g, Betamethasone (valerate) - 1mg/g Cream 216,359 L.L
C10AA05 TOVAST G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 1,127,484 L.L
C10AA05 TULIP G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 1,263,212 L.L
C09CA03 TABUVAN G Valsartan - 80mg 80mg Tablet, film coated 387,027 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
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