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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
C10AA08 LIVAZO B Pitavastatin - 4mg 4mg Tablet, film coated 1,835,305 L.L
C10AB04 LOPID B Gemfibrozil - 600mg 600mg Tablet, film coated 498,566 L.L
C10AB05 LIPANTHYL B Fenofibrate - 160mg 160mg Tablet, film coated, modified release 1,154,238 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
C10AB05 LIPANTHYL 200 M B Fenofibrate - 200mg 200mg Capsule 1,115,364 L.L
N02AJ14 LENIZAK B Tramadol HCl - 75mg, Dexketoprofen - 25mg Tablet, film coated 494,534 L.L
L01EX08 LENVIMA B Lenvatinib - 4mg 4mg Capsule, hard 124,450,304 L.L
L01EX08 LENVIMA B Lenvatinib - 10mg 10mg Capsule, hard 124,450,304 L.L
C10BA06 LIPOCOMB B Rosuvastatin (calcium) - 10mg, Ezetimibe - 10mg Capsule, hard 2,701,123 L.L
C10BA06 LIPOCOMB B Rosuvastatin (calcium) - 20mg, Ezetimibe - 10mg Capsule, hard 2,701,123 L.L
D01AC12 LOMEXIN B Fenticonazole nitrate - 2g/100g 2% Cream 758,029 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/g 1% Cream 616,824 L.L
G01AF12 LOMEXIN B Fenticonazole nitrate - 200mg 200mg Ovule 810,359 L.L
G01AF12 LOMEXIN B Fenticonazole nitrate - 600mg 600mg Ovule 850,727 L.L
L01BB04 LITAK 10 B Cladribine - 2mg/ml 2mg/ml Injectable solution 130,295,163 L.L
A03CA02 LIBRAX DRAGEES B Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 435,405 L.L
G01AF12 LOMEXIN "T" B Fenticonazole nitrate - 1,000mg 1,000mg Ovule 909,037 L.L
L01BB04 LITAK 10 B Cladribine - 10mg/5ml 10mg/5ml Injectable solution 39,016,157 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/ml 1% Solution 506,629 L.L
R06AX29 LABIXTEN B Bilastine - 20mg 20mg Tablet 584,571 L.L
D01AE16 LOCERYL B Amorolfine - 125mg/2.5ml 5% Nail lacquer 1,076,418 L.L
R06AX29 LABIXTEN B Bilastine - 2.5mg/ml 2.5mg/ml Solution 463,626 L.L
N05AH02 LEPONEX B Clozapine - 100mg 100mg Tablet 1,975,448 L.L
C01AA05 LANOXIN PG B Digoxin - 0.05mg/ml 0.05mg/ml Elixir 307,740 L.L
C01AA05 LANOXIN B Digoxin - 0.25mg 0.25mg Tablet 215,015 L.L
S01BA14 LOTEMAX B Loteprednol etabonate - 0.5% 0.5% Drops suspension 1,038,790 L.L
G03CX01 LIVIAL B Tibolone - 2.5mg 2.5mg Tablet 1,135,547 L.L
L01BC59 LONSURF B Trifluridine - 20mg, Tipiracil - 8.19mg Tablet, film coated 75,019,126 L.L
L01BC59 LONSURF B Trifluridine - 15mg, Tipiracil - 6.14mg Tablet, film coated 58,102,683 L.L
C08CA08 LUSOPRESS B Nitrendipine - 20mg 20mg Tablet, scored 757,927 L.L
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