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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
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
M01AE01 BRUFEN B Ibuprofen - 600mg 600mg Tablet, film coated 407,003 L.L
N02AB03 PECFENT B Fentanyl (citrate) - 100mcg/spray 100mcg/spray Spray 4,343,299 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
C09CA01 COZAAR B Losartan potassium - 50mg 50mg Tablet 1,420,634 L.L
J07AH08 NIMENRIX B Polysaccharide of Neisseria meningitidis (serogroups A, C, Y and W-135) conjugated - 5mcg/0.5ml, Tetanus toxoid carrier protein - 44mcg/0.5ml Injectable lyophilised powder for solution+diluent 4,483,059 L.L
N02AB03 ABSTRAL B Fentanyl (citrate) - 200mcg 200mcg Tablet 5,261,143 L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 25mg 25mg Tablet, controlled release 2,845,587 L.L
R06AX13 CLARITINE B Loratadine (micronised) - 10mg 10mg Tablet 618,168 L.L
A10BH04 VIPIDIA B Alogliptin benzoate - 25mg 25mg Tablet, film coated 2,998,113 L.L
C03BA04 HYGROTON B Chlortalidone - 50mg 50mg Tablet 422,351 L.L
L01EF01 IBRANCE B Palbociclib - 100mg 100mg Capsule 172,164,216 L.L
N02AB03 ABSTRAL B Fentanyl (citrate) - 100mcg 100mcg Tablet 3,419,743 L.L
N06AB06 ZOLOFT B Sertraline HCl - 50mg 50mg Tablet, scored 596,666 L.L
R01AD12 AVAMYS B Fluticasone furoate - 27.5mcg/dose 27.5mcg/dose Suspension 722,987 L.L
A07BA01 BIOCARBON B Activated charcoal - 250mg 250mg Tablet 1,361,312 L.L
A10BH05 TRAJENTA B Linagliptin - 5mg 5mg Tablet, film coated 3,213,127 L.L
C03BA11 FLUDEX B Indapamide - 1.5mg 1.5mg Tablet, sustained release 517,379 L.L
G04BE08 CIALIS B Tadalafil - 20mg 20mg Tablet, film coated 3,101,588 L.L
J07AJ51 BOOSTRIX B Diphteria toxoid purified - ?2.5Lf/0.5ml, Tetanus toxoid purified - ?5Lf/0.5ml, Bordetella Pertussis Antigens: toxoid - 8mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 8mcg/0.5ml, Pertactine - 2.5mcg Al3+/0.5ml, Aluminium hydroxide - 0.3mg Al3+/0.5ml, Aluminium Phosphate - 0.2mg/0.5ml Injectable suspension 1,394,909 L.L
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