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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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
N02AF02 NALBUPHINE RENAUDIN 1% G Nalbuphine HCl - 20mg/2ml 20mg/2ml Injectable solution 1,181,238 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 613,662 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
J06BB01 RHESONATIV BioHuman Human anti-D (rh) immunoglobulin - 625IU/ml 625IU/ml Injectable solution 12,281,758 L.L
L03AA02 NEUTROMAX BioTech Filgrastim - 300mcg/ml 300mcg/ml Injectable solution 2,553,301 L.L
M01AE01 IBUPROFEN B. BRAUN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 231,141 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 344,754 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
J06BB02 TETAGAM P BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 2,958,325 L.L
L03AA02 NEUPOGEN BioTech Filgrastim - 300mcg/0.5ml 300mcg/0.5ml Injectable solution 5,250,393 L.L
M01AE01 ? IBUPROFEN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 383,955 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
J06BB02 TETANUS GAMMA BioHuman Human Tetanus Immunoglobulin - 250IU/ml 250IU/ml Injectable solution 3,077,399 L.L
L03AA02 NIVESTIM BioTech Filgrastim - 30MIU/0.5ml 30MIU/0.5ml Injectable solution 17,110,745 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 100UI/ml 100UI/ml Injectable solution 6,853,730 L.L
L03AA02 ZARZIO BioTech Filgrastim - 300mcg/0.5ml 30MU/0.5ml Injectable solution 13,053,190 L.L
B05BC01 OSMITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 500UI/5ml 500UI/5ml Injectable solution 26,599,935 L.L
L03AA02 ZARZIO BioTech Filgrastim - 300mcg/0.5ml 30MU/0.5ml Injectable solution 13,053,190 L.L
B05BC01 SERUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
J01GB06 MIACIN G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 2,015,764 L.L
L03AA13 NEULASTIM BioTech Pegfilgrastim - 6mg/0.6ml 6mg/0.6ml Injectable solution 56,925,965 L.L
B05BC01 SOLUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 603,320 L.L
J01GB06 ORLOBIN G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 329,241 L.L
J06BD01 SYNAGIS BioTech Palivizumab - 100mg/ml 100mg/ml Injectable solution 57,429,464 L.L
L03AA13 ZIEXTENZO BioTech Pegfilgrastim - 6mg 6mg Injectable solution 41,050,549 L.L
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