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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
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 200mg/5ml, Clavulanic Acid (potassium) - 28.5mg/5ml 228.5mg/5ml Powder for suspension 345,368 L.L
J01FA10 ZITHROFORTE G Azithromycin (dihydrate) - 500mg 500mg Tablet, film coated 485,127 L.L
L01EB02 TARESSA 100 G Erlotinib (HCl) - 100mg 100mg Tablet, film coated 82,247,256 L.L
L02BX03 ABIRATERONE ACETATE NEAPOLIS G Abiraterone acetate - 250mg 250mg Tablet 75,418,662 L.L
M01AE01 FEBRIDEX ELIXIR G Ibuprofen - 100mg/5ml 100mg/5ml Elixir 262,369 L.L
N03AX16 PREGABADOR G Pregabalin - 75mg 75mg Capsule, hard 364,181 L.L
N06AB05 UNIROX G Paroxetine (HCl) - 20mg 20mg Tablet, film coated 854,684 L.L
L02BX03 ABREMIA G Abiraterone acetate - 250mg 250mg Tablet L.L
A04AA02 SANCUSO G Granisetron - 3.1mg/24h 3.1mg/24h Patch 7,590,728 L.L
A10BD11 INAGLIMET G Metformin - 1000mg, Linagliptin - 2.5mg Tablet, film coated 1,670,844 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 188,772 L.L
C01EB10 CARDESINE G Adenosine - 6mg/2ml 6mg/2ml Injectable solution 563,070 L.L
C09AA05 TRILTEC G Ramipril - 5mg 5mg Capsule 447,948 L.L
C10AA05 APO-ATORVASTATIN G Atorvastatin (calcium) - 10mg 10mg Tablet 889,624 L.L
G04BD08 URISOL G Solifenacin succinate - 5mg 5mg Tablet, film coated 1,334,884 L.L
L01EB02 APO-ERLOTINIB G Erlotinib (HCl) - 150mg 150mg Tablet 91,523,229 L.L
L02BX03 ABIRATERONE ACETATE SPC G Abiraterone acetate - 250mg 250mg Tablet, film coated 92,278,660 L.L
M01AE01 FEVERAL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 309,724 L.L
N03AX16 PREGAFORTE 75 G Pregabalin - 75mg 75mg Capsule 793,507 L.L
N06AB05 DEPROX G Paroxetine (HCl) - 40mg 40mg Tablet 2,909,099 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 70mg 70mg Tablet, film coated L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 204,554 L.L
C10AA05 ASCOVA G Atorvastatin (calcium) - 10mg 10mg Tablet, scored 1,126,268 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57.1mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
L01EB02 MIRATA G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 88,599,923 L.L
L02BX03 ABLAX 250 G Abiraterone acetate - 250mg 250mg Tablet 45,056,853 L.L
M01AE01 IBUSOL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 309,724 L.L
N03AX16 PREGASTAR G Pregabalin - 75mg 75mg Capsule, hard 628,482 L.L
R01AD11 RINEX G Triamcinolone acetonide - 55mcg/actuation 55mcg/actuation Spray, suspension 712,876 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 50mg 50mg Tablet, film coated L.L
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