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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
J01MA14 MOFLOXINE G Moxifloxacin (HCl) - 400mg/250ml 400mg/250ml Injectable solution 1,638,144 L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE G Bendamustine HCl - 100mg/50ml 100mg/50ml Injectable powder for concentrate for solution 78,439,178 L.L
L01EX01 SUNITINIB AQVIDA G Sunitinib maleate - 12.5mg 12.5mg Capsule, hard 41,692,397 L.L
M01AE02 NAPROXENE SODIQUE ARROW G Naproxen (sodium) - 550mg 550mg Tablet, film coated, scored 255,330 L.L
N02AF02 NALBUPHINE RENAUDIN 1% G Nalbuphine HCl - 20mg/2ml 20mg/2ml Injectable solution 1,181,238 L.L
N03AX14 LEPITAM G Levetiracetam - 100mg/ml 100mg/ml Solution 1,336,163 L.L
R01AD11 RINEX G Triamcinolone acetonide - 55mcg/actuation 55mcg/actuation Spray, suspension 470,985 L.L
R06AX DESLOCORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 1,009,802 L.L
L04AX04 LENOMA G Lenalidomide - 15mg 15mg Capsule, hard L.L
A11DB TRILAGAVIT G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 579,196 L.L
B05XA03 ISOTONIC SALINE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
C07AB04 ACEBUTOLOL BIOGARAN G Acebutolol HCl - 200mg 200mg Tablet, coated 464,970 L.L
C09DA03 CO-TABUVAN G Valsartan - 160mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 544,256 L.L
C10BA02 INEGY G Simvastatin - 20mg, Ezetimibe - 10mg Tablet 4,452,598 L.L
D11AX TRIO-2000 G Hydroquinone - 4%, Tretinoin - 0.05%, Hydrocortisone acetate - 1% Ointment 2,495,068 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g, Lidocaine (ampoule) - 0.5g Injectable powder for solution+diluent 403,153 L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE PHARMINICIO G Bendamustine HCl - 100mg/50ml 100mg/50ml Injectable powder for concentrate for solution 78,439,178 L.L
L04AA13 AROTAN G Leflunomide - 20mg 20mg Tablet, film coated 2,014,420 L.L
M01AE02 ANODYNE 500 G Naproxen - 500mg 500mg Suppository 342,680 L.L
N03AX14 LEVETIRACETAM ARROW G Levetiracetam - 100mg/ml 100mg/ml Solution 1,639,488 L.L
R06AX DESLOCORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 673,201 L.L
A11DB VITANOR G Vitamin B1 - 250mg, Vitamin B6 - 250mg, Vitamin B12 - 500mcg Tablet, film coated 946,065 L.L
B05XA03 ISOTONIC SALINE G Sodium chloride - 0.9% 0.9% Injectable solution 170,630 L.L
C09DA03 VALUSTAR PLUS G Valsartan - 160mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 592,635 L.L
C10BA02 INEGY G Simvastatin - 40mg, Ezetimibe - 10mg Tablet 4,484,594 L.L
D11AX01 ALOPEXY G Minoxidil - 20mg/ml 2% Solution 532,162 L.L
G04CB02 DUTASTERIDE ARROW LAB G Dutasteride - 0.5mg 0.5mg Capsule, soft 1,166,455 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 0.5g 0.5g Injectable powder for solution 3,455,595 L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (100mg) 2.5mg/ml Injectable powder for concentrate for solution 16,887,989 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 25mg 25mg Capsule 64,804,314 L.L
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    130
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