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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
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 222,941 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
C08CA05 NIFELAT 30 LA G Nifedipine - 30mg 30mg Tablet, prolonged release 1,007,882 L.L
C09DX01 VIOSTAN AM PLUS 160/10/25 G Valsartan - 160mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,196,020 L.L
D05AX52 BETA-CAL G Calcipotriol (monohydrate) - 50mcg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 1,574,983 L.L
J01DE01 CEFIPEX 500 BENTA G Cefepime (hydrochloride) - 500mg 500mg Injectable solution 545,216 L.L
J02AX04 CASPOFUNGINE STRAGEN G Caspofungin (acetate) - 70mg 70mg Injectable concentrated powder for solution 22,928,852 L.L
L01CA02 CELLCRISTIN G Vincristine sulfate - 1mg/ml 1mg/ml Injectable solution 1,443,287 L.L
M03AC09 ROCUCELL G Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 3,633,494 L.L
N02BE01 SOLUFLEX PARACETAMOL G Paracetamol - 1g/100ml 1g/100ml Injectable solution 211,175 L.L
N05AH03 ZOLAPINE G Olanzapine - 5mg 5mg Tablet, orodispersible 1,186,165 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 18mg 18mg Capsule 3,744,073 L.L
R03BB01 IPRAVENT G Ipratropium bromide - 20mcg/2ml 20mcg/2ml Inhalation solution 630,262 L.L
S01BC04 FLUROPTIC G Flurbiprofen sodium - 0.03% w/v 0.03% w/v Drops solution 223,078 L.L
B01AC04 CLOPIKEY G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 748,520 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 158,587 L.L
C08CA05 NIFELAT 60 LA G Nifedipine - 60mg 60mg Tablet, prolonged release 1,290,089 L.L
D05AX52 ROLIP G Calcipotriol - 50mcg, Betamethasone - 0.5mg Ointment 1,574,983 L.L
J01DE01 CEFEPIME LDP LABORATORIOS TORLAN G Cefepime - 1g 1g Injectable powder for solution 5,933,065 L.L
L01CA04 EBERELBIN G Vinorelbine (tartrate) - 50mg/5ml 50mg/5ml Injectable concentrated solution 6,834,783 L.L
M03AC09 RUCORON G Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 3,711,693 L.L
N02BE01 ? PARACETAMOL G Paracetamol - 1g/100ml 1g/100ml Injectable solution 191,978 L.L
N05AH03 ZYRWAN OD G Olanzapine - 5mg 5mg Tablet, orodispersible 831,391 L.L
N06BA09 APO-ATOMOXETINE G Atomoxetine (HCl) - 10mg 10mg Capsule 2,981,987 L.L
S01CA01 API-TOBRASON G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 294,302 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
B01AC04 CLOPISTOP G Clopidogrel - 75mg 75mg Tablet, film coated 1,081,473 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 179,272 L.L
C01BD01 AMIODARONE BIOGARAN G Amiodarone (HCl) - 200mg 200mg Tablet 345,368 L.L
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