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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
C10AA01 SIMVASTATIN NORMON G Simvastatin - 40mg 40mg Tablet, film coated 264,737 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 40mg 40mg Tablet, film coated 780,772 L.L
C10AA01 STAVINE G Simvastatin - 40mg 40mg Tablet, scored 207,336 L.L
C10AA01 VASCOR G Simvastatin - 40mg 40mg Tablet, scored 284,127 L.L
C10AA03 APO-PRAVASTATIN G Pravastatin Sodium - 40mg 40mg Tablet 958,160 L.L
C10AA03 PRAVASTATINE ARROW G Pravastatin - 40mg 40mg Tablet, breakable 526,786 L.L
C10AA03 STAVACOR G Pravastatin sodium - 40mg 40mg Tablet, scored 891,799 L.L
L02BB04 ENZASTIK 40 G Enzalutamide - 40mg 40mg Capsule L.L
L04AB04 ADALIREL BioTech Adalimumab - 40mg 40mg Injectable solution L.L
B01AB05 HEPAXANE 4000IU BioTech Enoxaparin sodium - 40mg/0.4ml 40mg/0.4ml Injectable solution 3,559,839 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 34,045,375 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 52,871,023 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 52,871,023 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
L04AB04 CINNORA BioTech Adalimumab - 40mg/0.8ml 40mg/0.8ml Injectable solution 14,817,734 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
J01GB03 GENTAMICINE PANPHARMA G Gentamicin (sulfate) - 40mg/2ml 40mg/2ml Injectable solution 643,701 L.L
H02AB04 LISAMETHYLE G Methylprednisolone sodium succinate - 40mg/2ml 40mg/2ml Injectable powder for solution+diluent 7,905,545 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable concentrated solution 2,123,271 L.L
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution 51,234,726 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
S01LA05 EYLEA BioTech Aflibercept - 40mg/ml 40mg/ml Injectable solution 65,161,855 L.L
L03AX03 SII-ONCO-BCG G Bacillus Calmette- Guerin Strain - 40mg/ml (1-8x10?CFU) 40mg/ml Injectable dry powder 6,987,981 L.L
A03AX13 OVOL B Simethicone - 40mg/ml 40mg/ml Drops 233,829 L.L
H02AB04 DEPO MEDROL B Methylprednisolone acetate - 40mg/ml 40mg/ml Injectable suspension 182,763 L.L
H02AB08 TRIACORT G Triamcinolone acetonide - 40mg/ml 40mg/ml Injectable suspension 745,833 L.L
L01FX29 TALVEY B Talquetamab - 40mg/ml 40mg/ml Injectable solution 555,916,745 L.L
S01LA05 EYLEA BioTech Aflibercept - 40mg/ml 40mg/ml Injectable solution L.L
L01EL01 IMBRUVICA B Ibrutinib - 420mg 420mg Tablet, film coated 584,283,050 L.L
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