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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
H02AB02 DEXAMETHASONE G Dexamethasone - 0.5mg/5ml 0.5mg/5ml Elixir 119,026 L.L
R05CB02 BROMHEXINE G Bromhexine - 4mg/5ml 4mg/5ml Elixir 176,619 L.L
C01AA05 LANOXIN PG B Digoxin - 0.05mg/ml 0.05mg/ml Elixir 307,740 L.L
R05X BROMEX G Pyrilamine Maleate (Mepyramine) - 12.5mg/5ml, Bromhexine HCl - 4mg/5ml Elixir 250,851 L.L
P02CB01 PIPERAZINE CITRATE G Piperazine citrate - 750mg/5ml 750mg/5ml Elixir 113,907 L.L
J07CA LANTIGEN B B Streptococcus pneumoniae type 3 (antigenic extracts) - 63.2A.U./ml, Streptococcus pyogenes group A (antigenic extracts) - 126.2A.U./ml, Branhamella catarrhalis (antigenic extracts) - 39.9A.U./ml, Staphylococcus aureus (antigenic extracts) - 79.6A.U./ml, Haemophilus influenzae type b (antigenic extracts) - 50.2A.U./ml, Klebsiella pneumoniae (antigenic extracts) - 39.8A.U./ml Drops suspension 916,501 L.L
S01AE01 OPTIFLOX G Ofloxacin - 3mg/ml 3mg/ml Drops suspension 143,791 L.L
S01BA04 PRED FORTE B Prednisolone acetate - 10mg/ml 1% Drops suspension 260,705 L.L
S01BA04 PRED FORTE B Prednisolone acetate - 10mg/ml 1% Drops suspension 260,705 L.L
S01BA14 LOTEMAX B Loteprednol etabonate - 0.5% 0.5% Drops suspension 1,038,790 L.L
S01CA01 API-TOBRASON G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 294,302 L.L
S01CA01 CO-AVAZIR G Tobramycin - 0.3%, Dexamethasone - 0.1% Drops suspension 193,513 L.L
S01CA01 DEXATOBRIN G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 239,204 L.L
S01CA01 OPTIDEX T G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 266,081 L.L
S01CA02 LOXTRA G Prednisolone acetate - 2mg/ml, Tetrahydrozoline HCl - 0.4mg/ml, Ofloxacin - 3mg/ml Drops suspension 423,310 L.L
S01EC04 AZOPT B Brinzolamide - 10mg/ml 10mg/ml Drops suspension 804,962 L.L
S01EC54 SIMBRINZA B Brinzolamide - 1%, Brimonidine tartrate - 0.2% Drops suspension 1,706,680 L.L
S03CA04 MYCICORT G Hydrocortisone acetate - 5mg, Neomycin sulfate - 5mg Drops suspension 166,381 L.L
M01AC01 BRUXICAM B Piroxicam - 0.5% Drops solution 530,818 L.L
S01AA12 TOBRASTILL G Tobramycin - 0.3% 0.3% Drops solution 258,018 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Drops solution 1,343,843 L.L
S01AA23 NETTACIN B Netilmicin - 0.3% 0.3% Drops solution 681,328 L.L
S01AA26 AZYTER G Azithromycin (dihydrate) - 15mg/g 15mg/g Drops solution 412,560 L.L
S01AE01 OFLOX B Ofloxacin - 3mg/ml 0.3% Drops solution 366,869 L.L
S01AE01 OFLOX B Ofloxacin - 0.3% 0.3% Drops solution 366,869 L.L
S01AE01 FLOXIGEN G Ofloxacin - 3mg/ml 3mg/ml Drops solution 358,806 L.L
S01AE03 CILOXAN B Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops solution 348,055 L.L
S01AE06 TYMER G Gatifloxacin (sesquihydrate) - 3mg/ml 3mg/ml Drops solution 427,342 L.L
S01AE07 FORTYMOX G Moxifloxacin (HCl) - 0.5% 0.5% Drops solution 772,709 L.L
S01AE07 MOXITEC G Moxifloxacin (HCl) - 5mg/ml 5mg/ml Drops solution 464,970 L.L
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