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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
J07BC02 VAQTA B Hepatitis A, inactivated, whole virus - 25U/0.5ml 25U/0.5ml Injectable suspension 2,539,862 L.L
L01EJ01 JAKAVI B Ruxolitinib - 5mg 5mg Tablet 165,514,059 L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet 29,146,785 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.7mg 0.7mg Tablet 2,478,046 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release L.L
A07AA11 NORMIX TAB B Rifaximin alpha - 200mg 200mg Tablet, film coated 827,807 L.L
B01AF02 ELIQUIS B Apixaban - 2.5mg 2.5mg Tablet, film coated 4,183,603 L.L
C09CA03 DIOVAN B Valsartan - 80mg 80mg Tablet, film coated 602,041 L.L
D07XC01 LOTRIDERM B Betamethasone (dipropionate) - 0.5mg/g, Clotrimazole - 10mg/g Cream 408,528 L.L
L04AA18 CERTICAN B Everolimus - 0.75mg 0.75mg Tablet 39,404,119 L.L
N06AX11 REMERON SOLTAB B Mirtazapine - 30mg 30mg Tablet, orodispersible 1,486,290 L.L
R07AA INFASURF B Calfactant - 210mg/6ml 35mg/ml Injectable suspension 40,596,749 L.L
A07AA11 NORMIX SIROP B Rifaximin alpha - 100mg/5ml 100mg/5ml Granules for suspension 477,064 L.L
L01EJ01 JAKAVI B Ruxolitinib - 15mg 15mg Tablet 326,608,760 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.75mg 0.75mg Tablet, extended release 942,034 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
R07AA INFASURF B Calfactant - 105mg/3ml 35mg/ml Injectable suspension 23,344,161 L.L
A07AA12 DIFICLIR B Fidaxomicin - 200mg 200mg Tablet, film coated 130,192,063 L.L
D07XC01 DIPROSALIC B Salicylic acid - 30mg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 352,087 L.L
G04BE08 CIALIS B Tadalafil - 5mg 5mg Tablet, film coated 6,512,261 L.L
J07BD52 PRIORIX B Rubella virus live attenuated - ?10³ CCID50, Mumps virus live attenuated - ?103.7 CCID50, Measles virus live attenuated - ?10³ CCID50 Injectable lyophilised powder for solution+diluent 1,142,266 L.L
L04AA27 GILENYA B Fingolimod - 0.5mg 0.5mg Capsule 159,392,560 L.L
M01AG01 PONSTAN FORTE B Mefenamic acid - 500mg 500mg Tablet, film coated 219,046 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.375mg 0.375mg Tablet, extended release 473,033 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 75mg 75mg Capsule, sustained release 732,394 L.L
R03AK07 SYMBICORT TURBUHALER B Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Inhalation powder 1,689,210 L.L
R07AA01 SURVANTA B Colfosceril palmitate - 200mg/8ml 200mg/8ml Suspension 36,957,499 L.L
A10BH04 VIPIDIA B Alogliptin benzoate - 25mg 25mg Tablet, film coated 2,998,113 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 250mg/5ml 250mg/5ml Granules for suspension 477,384 L.L
J07BD52 M-M-R II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE) B Rubella virus live attenuated - , Mumps virus live attenuated - , Measles virus live attenuated - Injectable solution+diluent 12,924,401 L.L
    5
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