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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
N02AB03 DUROGESIC B Fentanyl - 16.8mg 100mcg/h Patch 5,911,563 L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule L.L
C09BX01 TRIPLIXAM B Perindopril arginine - 10mg, Indapamide - 2.5mg, Amlodipine - 10mg Tablet, film coated 1,315,622 L.L
L01ED05 LORBRENA B Lorlatinib - 100mg 100mg Tablet 403,677,371 L.L
N02AB03 DUROGESIC B Fentanyl - 8.4mg 50mcg/h Patch 3,019,614 L.L
R06AX CYPRO-BC B Cyproheptadine HCl - 2mg/5ml, Vitamin B3 - 5mg/5ml, Vitamin B6 - 0.60mg/5ml, Vitamin B2 - 0.75mg/5ml, Vitamin B1 - 0.60mg/5ml, Vitamin C - 20mg/5ml Syrup 449,227 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution L.L
A07AA11 NORMIX TAB B Rifaximin alpha - 200mg 200mg Tablet, film coated 827,807 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated 201,006,231 L.L
C09BX02 COSYREL B Perindopril arginine - 5mg, Bisoprolol fumarate - 5mg Tablet, film coated, scored 749,864 L.L
D07AD01 DERMOVATE B Clobetasol (propionate) - 0.5mg/g 0.05% w/w Ointment 290,270 L.L
J01MA02 CIPROBAY B Ciprofloxacine (HCl) - 500mg 500mg Tablet, film coated 654,451 L.L
L01EF01 IBRANCE B Palbociclib - 75mg 75mg Capsule 172,164,216 L.L
N02AB03 DUROGESIC B Fentanyl - 4.2mg 25mcg/h Patch 1,509,135 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
R06AX02 PERIACTIN B Cyproheptadine HCl - 4mg 4mg Tablet 255,970 L.L
L01EL01 IMBRUVICA B Ibrutinib - 420mg 420mg Tablet, film coated L.L
A07AA11 NORMIX SIROP B Rifaximin alpha - 100mg/5ml 100mg/5ml Granules for suspension 477,064 L.L
C02LA51 ADELPHAN ESIDREX B Reserpine - 0.1mg, Hydrochlorothiazide - 10mg, Dihydralazine - 10mg Tablet 371,157 L.L
C09BX02 COSYREL B Perindopril arginine - 10mg, Bisoprolol fumarate - 5mg Tablet, film coated, scored 749,864 L.L
J01CR02 AUGMENTIN B Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 739,202 L.L
J07AH08 MENACTRA MENINGOCOCCAL POLYSACCHARIDE DIPHTERIA TOXOID CONJUGATE VACCINE B Meningococcal Polysaccharides (serogroups A, C, Y and W-135) - 4mcg/0.5ml each, Diphteria Toxoid Protein - 48mcg/0.5ml Injectable solution 6,144,048 L.L
L01EF01 IBRANCE B Palbociclib - 75mg 75mg Tablet, film coated 172,164,216 L.L
N02AB03 PECFENT B Fentanyl (citrate) - 400mcg/spray 400mcg/spray Spray 5,718,050 L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 12.5mg 12.5mg Tablet, controlled release 2,371,608 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
R06AX13 CLARITINE B Loratadine (micronised) - 10mg 10mg Tablet 219,046 L.L
A07AA12 DIFICLIR B Fidaxomicin - 200mg 200mg Tablet, film coated 130,192,063 L.L
B01AF02 ELIQUIS B Apixaban - 2.5mg 2.5mg Tablet, film coated 4,183,603 L.L
C03AA03 ESIDREX B Hydrochlorothiazide - 25mg 25mg Tablet 380,115 L.L
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