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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
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution 172,758,585 L.L
J01DH02 ROPENEM 1000 BENTA G Meropenem (trihydrate) - 1000mg 1g Injectable powder for solution 995,723 L.L
L01DB02 CERUBIDINE B Daunorubicin (HCl) - 20mg 20mg Injectable powder for solution 10,943,137 L.L
J01DH51 IMILASTIN G Imipenem - 500mg, Cilastatin - 500mg Injectable powder for solution 5,869,189 L.L
J01DH51 IMIPENEM-CILASTATIN LABATEC G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 8,922,845 L.L
J01DH51 IMIPENEME CILASTATINE PANPHARMA G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 10,840,366 L.L
L01DC01 BLEO-CELL G Bleomycin (sulfate) - 15mg 15mg Injectable powder for solution 3,054,554 L.L
J01AA12 TEGADIS G Tigecycline - 50mg 50mg Injectable powder for solution 2,418,917 L.L
N01AF03 THIOPENTAL PANPHARMA G Thiopental - 500mg 500mg Injectable powder for solution 8,446,717 L.L
N01AH06 ULTIVA B Remifentanil (HCl) - 5mg 5mg Injectable powder for solution 2,990,050 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 500mg 500mg Injectable powder for solution 1,944,540 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 1g 1g Injectable powder for solution 2,857,009 L.L
N01AH06 ULTIVA B Remifentanil (HCl) - 2mg 2mg Injectable powder for solution 1,632,769 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Injectable powder for solution 1,428,505 L.L
J01CA04 AMOXICILLINE INJ. G Amoxicillin (sodium) - 1g 1g Injectable powder for solution 1,173,175 L.L
J01CA04 AMOXICILLINE PANPHARMA G Amoxicillin (sodium) - 1g 1g Injectable powder for solution 2,734,719 L.L
J01CE01 PENICILLINE G PANPHARMA G Benzylpenicillin (sodium) - 1,000,000IU 1,000,000IU Injectable powder for solution 2,858,353 L.L
J01CR02 AMOXICILLINA/ ACIDO CLAVULANICO G Amoxicillin (sodium) - 1g, Clavulanic Acid (potassium) - 200mg 1.2g Injectable powder for solution 16,577,136 L.L
J01CR02 AMOXICLAV-ORBUCELL G Amoxicillin - 1g, Clavulanic Acid (potassium) - 0.2g Injectable powder for solution 7,433,691 L.L
J01CR02 MOXICLAV G Amoxicillin - 1g, Clavulanic Acid - 200mg 1.2g Injectable powder for solution 162,605 L.L
J02AA01 AMBISOME B Liposomal Amphotericin B - 50mg 50mg Injectable powder for liposomal dispersion 13,126,040 L.L
L01CD01 ABRAXANE BioTech Paclitaxel Albumin- bound - 5mg/ml 5mg/ml Injectable powder for dispersion 17,850,751 L.L
L01FD01 ARYOTRUST BioTech Trastuzumab - 440mg 440mg Injectable powder for concentrate for solution + solvent 34,948,930 L.L
A16AB04 FABRAZYME BioTech Agalsidase beta - 35mg 35mg Injectable powder for concentrate for solution L.L
L04AB02 IXIFI BioTech Infliximab - 100mg 100mg Injectable powder for concentrate for solution L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 100mg 100mg Injectable powder for concentrate for solution L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 160mg 160mg Injectable powder for concentrate for solution L.L
L01AA09 BENDAMUSTINE HYDROCHLORIDE G Bendamustine HCl - 25mg/10ml 25mg/10ml Injectable powder for concentrate for solution 19,610,153 L.L
L01FX05 ADCETRIS BioTech Brentuximab Vedotin - 50mg 50mg Injectable powder for concentrate for solution L.L
L01AA09 BENDAMUSTINE MEDAC G Bendamustine HCl - 2.5mg/ml (25mg) 2.5mg/ml Injectable powder for concentrate for solution 24,934,922 L.L
    ...
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    ...
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