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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
C10BX03 JOSWE DUBARA 10/10 G Amlodipine - 10mg, Atorvastatin - 10mg Caplet, film coated 2,655,433 L.L
N05AX08 RESPAL 4 G Risperidone - 4mg 4mg Caplet, film coated 557,695 L.L
C09DB01 ARBITEN AM 5/160 G Amlodipine - 5mg, Valsartan - 160mg Caplet, film coated 857,372 L.L
C09DB01 ARBITEN AM 10/160 G Amlodipine - 10mg, Valsartan - 160mg Caplet, film coated 857,372 L.L
C10AA05 JOSWE ATORVAST 10 G Atorvastatin - 10mg 10mg Caplet, film coated 849,308 L.L
L01EF01 PALBOMED G Palbociclib - 125mg 125mg Capsule 25,799,521 L.L
L01EF01 PALBRANCE 125 G Palbociclib - 125mg 125mg Capsule 69,032,469 L.L
J07AX URO-VAXOM B Lyophilized bacterial lysates of E-Coli - 6mg 6mg Capsule 2,689,029 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 L.L
L04AA06 CELLCEPT B Mycophenolate mofetil - 250mg 250mg Capsule 6,083,575 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU 500,000IU Capsule 417,231 L.L
J01CR50 FLUMOX G Flucloxacillin (monohydrate) - 250mg, Amoxicillin (trihydrate) - 250mg Capsule 348,055 L.L
L04AA27 GILENYA B Fingolimod - 0.5mg 0.5mg Capsule 159,392,560 L.L
A02BC01 AXIPRON G Omeprazole - 20mg 20mg Capsule 373,358 L.L
A07AX03 FUROXYL G Nifuroxazide - 200mg 200mg Capsule 366,037 L.L
A02BC01 DIGCAP G Omeprazole - 20mg 20mg Capsule 593,850 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 500mg 500mg Capsule 659,123 L.L
L04AA27 PMS-FINGOLIMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 19,351,580 L.L
M01AH01 CELECOXIB BIOGARAN G Celecoxib - 100mg 100mg Capsule 318,491 L.L
A02BC01 GASTRAZOLE G Omeprazole - 20mg 20mg Capsule 245,923 L.L
A07BA51 CARBOSYLANE B Simethicone (blue-red) - 45mg (blue-red), Activated charcoal (blue-red) - 140mg (blue-red) Capsule 585,915 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
M01AH01 CELEBREX B Celecoxib - 200mg 200mg Capsule 1,126,140 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
M01AH01 CELECOXIB ARROW LAB G Celecoxib - 200mg 200mg Capsule 561,726 L.L
M01AH01 CELECOXIB BIOGARAN G Celecoxib - 200mg 200mg Capsule 638,325 L.L
A02BC01 GASTRISEC G Omeprazole - 20mg 20mg Capsule 413,903 L.L
M01AH01 JOSWE FLAMEX 200 G Celecoxib - 200mg 200mg Capsule 225,766 L.L
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