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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
J07AH08 MENQUADFI G Meningococcal (serogroups A, C, W and Y) conjugate vaccine - Injectable solution 4,859,334 L.L
L01EF01 PAPILLIO G Palbociclib - 75mg 75mg Capsule, hard 147,883,080 L.L
M01AE01 PROFINAL G Ibuprofen - 600mg 600mg Tablet 302,365 L.L
N03AX16 PREGAFORTE 100 G Pregabalin - 100mg 100mg Capsule 998,283 L.L
R06AX13 APOTHECARE LORATADINE G Loratadine - 10mg 10mg Tablet 495,878 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 1mg 1mg Tablet, coated L.L
A02BC01 GASTRIMUT G Omeprazole - 20mg 20mg Capsule, hard, gastro-resistant 6,720,556 L.L
B01AF02 APO-APIXABAN G Apixaban - 2.5mg 2.5mg Tablet 3,084,119 L.L
B05CX01 DEXTROSE 20% INJECTION USP G Glucose - 20% 20% Injectable solution 183,869 L.L
C09CA01 LOSANET G Losartan potassium - 50mg 50mg Tablet 395,474 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
D07CA01 MYCICORT G Neomycin sulfate - 5mg/g, Hydrocortisone acetate - 10mg/g Ointment 485,063 L.L
J01CR02 CURAM G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet, film coated 520,619 L.L
J01MA02 CIPRODAR G Ciprofloxacine (HCl) - 500mg 500mg Tablet, film coated 392,402 L.L
M01AE01 DOLORAZ 400 G Ibuprofen - 400mg 400mg Capsule 295,645 L.L
N03AX16 GABRIKA 25 G Pregabalin - 25mg 25mg Capsule 560,062 L.L
R06AX13 CLARA G Loratadine (micronised) - 10mg 10mg Tablet 131,697 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 0.5mg 0.5mg Tablet, coated L.L
A02BC01 GASTRISEC G Omeprazole - 20mg 20mg Capsule 413,903 L.L
A10BH05 INAGLIP G Linagliptin - 5mg 5mg Tablet, film coated 1,242,606 L.L
B01AF02 AVIXAN G Apixaban - 2.5mg 2.5mg Tablet, film coated 2,777,275 L.L
B05CX01 5% DEXTROSE INJECTION USP G Glucose - 5% 5% Injectable solution 148,244 L.L
C03BA11 ADEX G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 296,989 L.L
C09CA01 LOSARTAN BIOGARAN G Losartan potassium - 50mg 50mg Tablet, coated, scored 439,436 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
D07CB01 PANDERM G Triamcinolone acetonide - 1mg/g, Gramicidin - 0.25mg/g, Neomycin (sulfate) - 2.5mg/g, Nystatin - 100.000IU/g Cream 180,075 L.L
G04BE08 APO-TADALAFIL G Tadalafil - 20mg 20mg Tablet 1,111,358 L.L
J01CR02 JULMENTIN 2X G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 401,809 L.L
J01MA02 CIPROFAR G Ciprofloxacine (HCl) - 500mg 500mg Tablet, film-scored 241,892 L.L
M01AE01 IBUPROFEN B. BRAUN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 231,141 L.L
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