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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
C05AA01 SEDIPROCT G Hydrocortisone - 5mg, Cinchocaine HCl - 5mg, Framycetin sulfate - 10mg, Esculoside - 10mg Suppository 237,860 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 186,167 L.L
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 5mg, Lidocaine - 60mg, Zinc oxide - 400mg, Aluminium Subacetate - 50mg Suppository 501,253 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 205,703 L.L
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 0.275g/100g, Lidocaine - 5g/100g, Zinc oxide - 18g/100g, Aluminium Subacetate - 3.5g/100g Ointment 330,585 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 221,792 L.L
B05CX01 SOLUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 268,908 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 10mg 10mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 10mg 10mg Tablet, coated 517,379 L.L
J01DD01 STOPAREN G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 213,671 L.L
N02BE01 STOPALGIC G Paracetamol - 1g/100ml 1g/100ml Injectable solution 1,536,012 L.L
D10AF02 SPOTEX G Erythromycin - 4% 4% Gel 854,684 L.L
J01RA SPIRAGYL G Metronidazole - 125mg, Spiramycin - 750,000IU Tablet, scored 474,824 L.L
J01RA SPIRAGYL FORTE G Metronidazole - 250mg, Spiramycin - 1,500,000IU Tablet, scored 474,824 L.L
G04CA04 SILODOSINE ARROW G Silodosine - 4mg 4mg Capsule 732,394 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 4mg 4mg Capsule 555,007 L.L
G04CA04 SILODOSINE ARROW G Silodosine - 8mg 8mg Capsule 732,394 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 8mg 8mg Capsule 555,007 L.L
N02BE01 SOLUFLEX PARACETAMOL G Paracetamol - 1g/100ml 1g/100ml Injectable solution 211,175 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 563,070 L.L
N02BE01 SUPOFEN G Paracetamol - 10mg/ml 10mg/ml Injectable solution 7,675,286 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 20mg 20mg Tablet, coated 517,379 L.L
G04CB01 STERIFINE 5 G Finasteride - 5mg 5mg Tablet, film coated 733,354 L.L
N02BE51 SICADOL EXTRA G Paracetamol - 500mg, Caffeine - 65mg Tablet 147,823 L.L
N06CA02 SERNIL G Flupentixol - 0.5mg, Melitracen - 10mg Tablet 1,003,402 L.L
G04CB01 STERIBO G Finasteride - 1mg 1mg Tablet, film coated 2,636,619 L.L
A11CC05 SUN-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 935,570 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 5mg 5mg Tablet, film coated 387,027 L.L
N02BE51 SOLPEX G Paracetamol - 500mg, Caffeine - 30mg, Codeine - 8mg Tablet 243,172 L.L
M03AC11 SISACURE G Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 1,408,347 L.L
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