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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
P01AB01 PHOSVIT G Metronidazole benzoate - 125mg/5ml 125mg/5ml Suspension 207,336 L.L
R05DA20 ALGOMIEL COUGH SYRUP G Dextromethorphan HBr - 5mg, Carbinoxamine maleate - 2mg Syrup 639,925 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,018,089 L.L
A10BD07 SITAMET G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 2,444,896 L.L
B01AC04 GREPID G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,248,335 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 DOXY 50 G Doxycycline (hyclate) - 50mg 50mg Tablet, coated 311,771 L.L
J01DH02 MEROPENEM PANPHARMA G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 7,278,513 L.L
J05AF07 TENVOR G Tenofovir disoproxil fumarate - 300mg 300mg Tablet, film coated 3,753,352 L.L
L01XX05 CUREAML G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 1,228,272 L.L
M01AB05 DICLO-DENK 50 G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 893,655 L.L
M05BA08 ZOLEDRO-DENK G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 4,388,990 L.L
P01AB01 PHOZOLE G Metronidazole benzoate - 125mg/5ml 125mg/5ml Suspension 207,336 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 8mg/4ml 8mg/4ml Injectable solution 1,919,007 L.L
A10BD07 SITAVITEA G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
B01AC04 NORMIGORE G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,184,117 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
G03DA04 CYCLOGEST G Progesterone - 400mg 400mg Pessary 1,546,763 L.L
J01AA02 DOXY 100 G Doxycycline (hyclate) - 100mg 100mg Tablet, coated 788,836 L.L
J01DH02 MEROPENEM/ ANFARM G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 1mg 1mg Tablet, film coated 31,285,380 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 10mg/5ml 10mg/5ml Injectable concentrated solution 428,686 L.L
L01XX05 CYTODROX G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 3,301,821 L.L
M01AB05 DICLOGESIC G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 205,608 L.L
M05BA08 ZOLEDRONIC ACID ACCORD G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 7,028,741 L.L
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