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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
H02AB13 DEFAL B Deflazacort - 6mg 6mg Tablet 415,247 L.L
J02AC03 VFEND B Voriconazole - 200mg 200mg Tablet, film coated 51,904,550 L.L
N05AH03 ZYPREXA B Olanzapine - 5mg 5mg Tablet 1,197,364 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 36mg 36mg Tablet, extended release 4,393,021 L.L
S01BA01 OZURDEX B Dexamethasone - 700mcg 700mcg Implant 80,696,540 L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard L.L
A10BD02 GLUCOVANCE B Metformin HCl - 500mg, Glibenclamide - 5mg Tablet, film coated 775,971 L.L
G03BB01 PROVIRON B Mesterolone - 25mg 25mg Tablet 391,058 L.L
H02AB13 DEFAL B Deflazacort - 30mg 30mg Tablet 635,638 L.L
M02AA15 FLECTOR E.P TISSUGEL B Diclofenac (epolamine) - 1% 1% Patch 1,204,083 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 54mg 54mg Tablet, extended release 6,049,979 L.L
S01BA01 OZURDEX B Dexamethasone - 700mcg 700mcg Implant 80,696,540 L.L
B01AC04 PLAVIX B Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,350,562 L.L
D04AB01 VERSATIS B Lidocaine - 5% 5% Patch 13,085,712 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
M02AA15 VOLTAREN EMULGEL 12HRS B Diclofenac Diethylamine - 23.2mg/g 23.2mg/g Gel 1,169,143 L.L
N06BA04 CONCERTA B Methylphenidate HCl - 18mg 18mg Tablet, extended release 3,133,841 L.L
S01BA04 PRED FORTE B Prednisolone acetate - 10mg/ml 1% Drops suspension 260,705 L.L
B01AC04 PLAVIX B Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,350,562 L.L
C01AA05 LANOXIN PG B Digoxin - 0.05mg/ml 0.05mg/ml Elixir 307,740 L.L
D04AB01 VERSATIS B Lidocaine - 5% 5% Patch 2,772,347 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 25mcg 25mcg Tablet, scored 256,674 L.L
J01DD15 OMNICEF B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
J02AC03 V-FEND B Voriconazole - 200mg 200mg Injectable powder for solution 8,078,564 L.L
M02AA15 VOLTAREN EMULGEL 12HRS B Diclofenac Diethylamine - 23.2mg/g 23.2mg/g Gel 717,612 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 250mcg/actutaion 250mcg/actutaion Inhalation suspension 1,484,946 L.L
S01BA04 PRED FORTE B Prednisolone acetate - 10mg/ml 1% Drops suspension 260,705 L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 7,280,806 L.L
A10BD02 GLUCOVANCE B Metformin HCl - 1000mg, Glibenclamide - 5mg Tablet, film coated 1,006,220 L.L
C01AA05 LANOXIN B Digoxin - 0.25mg 0.25mg Tablet 215,015 L.L
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