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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
L01DB01 DOXO-CELL G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 1,794,030 L.L
L01XX35 ANAGRELIDE BIOGARAN G Anagrelide - 0.5mg 0.5mg Capsule 15,754,068 L.L
M01AB05 OLFEN-50 G Diclofenac sodium - 50mg 50mg Tablet, gastroresistant 248,611 L.L
M05BA08 SIMPLA G Zoledronic acid - 5mg/100ml 5mg/100ml Injectable solution 13,071,402 L.L
N03AX11 TOPIRATE 50 BENTA G Topiramate - 50mg 50mg Tablet, film coated 1,407,835 L.L
P01AB01 METRONIDAZOLE PANPHARMA G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 1,624,706 L.L
R05DB21 PRIVITUSS G L-Cloperastine - 708mg/100ml 708mg/100ml Suspension 801,186 L.L
A04AA01 TRONDAMET G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 2,027,858 L.L
B01AC04 CLOPIKEY G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 748,520 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 153,990 L.L
C01CA03 EPINORD G Noradrenaline (tartrate) - 8mg/4ml 8mg/4ml Injectable solution 2,751,678 L.L
C09DX01 ANGIOSAR PLUS G Valsartan - 320mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,689,210 L.L
D06AA04 TETRACYCLINE OINTMENT G Tetracycline HCl - 3% 3% Ointment 107,507 L.L
J01AA02 GRANUDOXY G Doxycycline (monohydrate) - 100mg 100mg Tablet, film-scored 282,207 L.L
J05AF10 ENTRILIV G Entecavir - 1mg 1mg Tablet, film coated 19,165,898 L.L
L01DB01 DOXORUBICINA TEDEC G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable concentrate for solution 2,015,764 L.L
M01AB05 PRIMAFENAC G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 223,974 L.L
N03AX11 TORAMAT G Topiramate - 50mg 50mg Tablet, film coated 1,032,071 L.L
P01AB01 METRONOR G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 5,359,244 L.L
V03AB35 PLIBADEX G Sugammadex - 500mg/5ml 500mg/5ml Injectable solution 94,888,925 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,109,630 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 205,933 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
C09DX01 VIOSTAN AM PLUS 320/10/25 G Valsartan - 320mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,881,380 L.L
G03DB08 DIENOSIS G Dienogest - 2mg 2mg Tablet 2,822,069 L.L
J01AA02 RETADOX G Doxycycline (hyclate) - 100mg 100mg Capsule 209,895 L.L
J01DH03 ERTANZ G Ertapenem - 1g 1g Injectable powder 2,521,049 L.L
J05AF10 HEPCAVIR 1 G Entecavir monohydrate - 1mg 1mg Tablet, film coated 18,998,515 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 2mg/ml 50mg/25ml Injectable concentrated solution 1,804,780 L.L
M01AB05 REMETHAN G Diclofenac sodium - 50mg 50mg Tablet 196,201 L.L
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