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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
B05BC01 SOLUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 603,320 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
C10AA05 STORVAS G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 362,837 L.L
A02BC01 SANAMIDOL G Omeprazole - 20mg 20mg Capsule 456,906 L.L
A02BC01 STOMAZOLE G Omeprazole - 20mg 20mg Capsule 593,850 L.L
A02BC01 STOMAZOLE G Omeprazole - 20mg 20mg Capsule 15,757,784 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 20mg 20mg Tablet, coated 517,379 L.L
L04AC02 SIMULECT BioTech Basiliximab - 20mg 20mg Injectable powder + solvent 131,822,828 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent 36,504,302 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
C10AA01 SIMVAKEY G Simvastatin - 20mg 20mg Tablet, film coated 716,268 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 20mg 20mg Tablet, film coated 264,737 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 20mg 20mg Tablet, film coated 542,912 L.L
C10AA01 STAVINE G Simvastatin - 20mg 20mg Tablet 207,336 L.L
N06AB05 SEROXAT B Paroxetine (HCl) - 20mg 20mg Tablet, film coated 1,586,205 L.L
C10AA03 STAVACOR G Pravastatin sodium - 20mg 20mg Tablet, scored 725,419 L.L
G04BE03 SILDENAFIL STRAGEN G Sildenafil - 20mg 20mg Tablet, coated 38,048,630 L.L
M03AC11 SISACURE G Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 1,408,347 L.L
M01AC02 SORAL G Tenoxicam - 20mg/2ml 20mg/2ml Injectable lyophilised powder for solution+solvent 588,603 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 178,731 L.L
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 250mcg/5ml 250mcg/5ml Injectable solution 3,524,899 L.L
N02BE01 SULDEX 250 G Paracetamol - 250mg 250mg Suppository 127,985 L.L
H02AB09 SOLU CORTEF ACT-O-VIAL B Hydrocortisone (sodium succinate) - 250mg 250mg Injectable lyophilised powder for solution+diluent 421,967 L.L
L04AD01 SANDIMMUN B Ciclosporin - 50mg/ml 250mg/5ml Injectable concentrated solution 6,992,013 L.L
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 25mg 25mg Capsule 64,804,314 L.L
N05AH04 SEROPINE 25 G Quetiapine fumarate - 25mg 25mg Tablet, film coated 1,233,647 L.L
L04AD01 SANDIMMUN NEORAL SOFT GELATIN B Ciclosporin - 25mg 25mg Capsule, soft gelatin 2,385,320 L.L
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