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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
C08DB01 MONO-TILDIEM LP/SR B Diltiazem HCl - 300mg 300mg Capsule, sustained release 658,483 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 491,846 L.L
L02BB03 CASODEX B Bicalutamide - 150mg 150mg Tablet, film coated 10,863,782 L.L
R06AE07 ZYRTEC B Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 593,978 L.L
A10BD07 JANUMET B Metformin HCl - 1000mg, Sitagliptin - 50mg Tablet 3,093,525 L.L
C09DX03 VOCADO HCT B Olmesartan medoxomil - 40mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,523,917 L.L
D06AX01 FUCIDIN OINTMENT B Fusidic acid (sodium salt) - 2% 2% Ointment 345,368 L.L
J05AR13 TRIUMEQ B Dolutegravir - 50mg, Abacavir sulfate - 600mg, Lamivudine - 300mg Tablet, film coated 74,756,237 L.L
L02BB04 XTANDI B Enzalutamide - 40mg 40mg Capsule, soft 267,649,535 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Solution 260,705 L.L
A10BD07 JANUMET B Metformin HCl - 1000mg, Sitagliptin - 50mg Tablet 3,093,525 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Injectable powder for solution 1,428,505 L.L
J05AR18 GENVOYA B Emtricitabine - 200mg, Tenofovir alafenamide - 10mg, Elvitegravir - 150mg, Cobicistat - 150mg Tablet, film coated 74,826,489 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 9,338,600 L.L
C09DX04 ENTRESTO B Valsartan - 26mg, Sacubitril - 24mg Tablet, film coated 6,029,821 L.L
J01FA09 KLACID B Clarithromycin - 125mg/5ml 125mg/5ml Granules for suspension 575,165 L.L
J05AR20 BIKTARVY B Bictegravir - 50mg, Emtricitabine - 200mg, Tenofovir alafenamide - 25mg Tablet, film coated 73,652,468 L.L
L02BB05 ERLEADA B Apalutamide - 60mg 60mg Tablet, film coated 254,089,146 L.L
N06AA02 TOFRANIL 10 B Imipramine HCl - 10mg 10mg Tablet, sugar coated 579,772 L.L
C09DX04 ENTRESTO B Valsartan - 51mg, Sacubitril - 49mg Tablet, film coated 6,029,821 L.L
J05AR24 DELSTRIGO B Lamivudine - 300mg, Tenofovir disoproxil - 300mg, Doravirine - 100mg Tablet, film coated 48,879,793 L.L
L01EA02 SPRYCEL B Dasatinib - 50mg 50mg Tablet 212,274,841 L.L
L02BB05 ERLEADA B Apalutamide - 60mg 60mg Tablet, film coated 254,089,146 L.L
N06AA02 TOFRANIL 25 B Imipramine HCl - 25mg 25mg Tablet, sugar coated 1,002,123 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Drops 241,892 L.L
C09DX04 ENTRESTO B Valsartan - 103mg, Sacubitril - 97mg Tablet, film coated 11,674,240 L.L
J01FA09 KLACID B Clarithromycin - 250mg/5ml 250mg/5ml Granules for suspension 1,698,617 L.L
L02BB06 NUBEQA B Darolutamide - 300mg Tablet, film coated 452,633,527 L.L
N06AA09 TRYPTIZOL B Amitryptiline (HCl) - 10mg 10mg Tablet, coated 668,751 L.L
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