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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
D11AX TRIO-2000 G Hydroquinone - 4%, Tretinoin - 0.05%, Hydrocortisone acetate - 1% Ointment 2,495,068 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
R02A TRACHISAN G Lidocaine HCl - 1mg, Tyrothricin - 0.5mg, Chlorhexidine gluconate - 1mg Lozenge 228,453 L.L
G01AA51 TERGYNAN G Nystatin - 100000IU, Neomycin (sulfate) - 65000IU, Metronidazole - 500mg Tablet 348,055 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 2.5mg Capsule, hard 1,029,383 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 5mg Capsule, hard 1,236,335 L.L
C10BX06 TRINOMIA B Acetylsalicylic acid - 100mg, Atorvastatin - 20mg, Ramipril - 10mg Capsule, hard 1,596,485 L.L
C09DA07 TELMICARD 80 PLUS G Telmisartan - 80mg, Hydrochlorothiazide - 12.5mg Tablet 954,768 L.L
C07BB03 TENORETIC B Chlortalidone - 25mg, Atenolol - 100mg Tablet, film coated 291,614 L.L
C09DB04 TWYNSTA B Telmisartan - 80mg, Amlodipine - 10mg Tablet 991,756 L.L
C09DB04 TWINCARD 80/10 G Telmisartan - 80mg, Amlodipine - 10mg Tablet 1,460,309 L.L
C09DB04 TWYNSTA B Telmisartan - 80mg, Amlodipine - 5mg Tablet 991,756 L.L
C09DB04 TWINCARD 80/5 G Telmisartan - 80mg, Amlodipine - 5mg Tablet 1,131,387 L.L
B06AC05 TAKHZYRO BioTech Lanadelumab - 300mg/2ml Injectable solution 1,204,227,927 L.L
C08DA51 TARKA B Verapamil - 180mg, Trandolapril - 2mg Capsule, modified release 2,422,948 L.L
C08DA51 TARKA B Verapamil - 240mg, Trandolapril - 4mg Tablet, modified release 3,797,532 L.L
D06AX TRIPLE ANTIBIOTIC ORIGINAL OINTMENT Bacitracin - 400U, Neomycin (sulfate) - 3.5mg, Polymyxin B (sulfate) - 5000U 580,540 L.L
M03BB52 TRANCODEX G Paracetamol - 450mg, Chlormezanone - 100mg Tablet 99,828 L.L
R03DB05 THEODEX G Ipeca fluide extract - 20mg, Aminophylline - 150mg, Caffeine - 100mg, Ephedrine - 15mg Tablet 156,142 L.L
S01ED51 TWINZOL G Dorzolamide HCl - 2%, Timolol - 0.5% Drops solution 632,950 L.L
S01ED51 TRAVOPROST/TIMOLOL BIOGARAN G Travoprost - 40mcg/ml, Timolol - 5mg/ml Drops solution 849,308 L.L
S01EE05 TAFLUPRO G Tafluprost - 0.0015% 0.0015% Solution 1,912,288 L.L
S01EE04 TRAVATAN B Travoprost - 40mcg/ml 0.004% Drops solution 806,306 L.L
S01EE04 TRAVONORM G Travoprost - 0.004% 0.004% Drops 564,414 L.L
D10AD01 TRETINOIN G Tretinoin - 0.025% 0.025% Solution 564,414 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
D10AD01 TRETINOIN G Tretinoin - 0.05% 0.05% Solution 623,287 L.L
R01AD09 TABUNEX G Mometasone furoate - 0.05% 0.05% Spray 419,279 L.L
D10AD01 TRETINOIN G Tretinoin - 0.1% 0.1% Solution 682,160 L.L
D11AH01 TACRUS G Tacrolimus monohydrate - 0.1% 0.1% Ointment 1,857,190 L.L
    2
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