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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
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 255,970 L.L
R06AX27 ORADUS G Desloratadine - 5mg 5mg Tablet, film coated 383,955 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated 201,006,231 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated L.L
L04AA32 OTEZLA B Apremilast - 4x10mg- 4x20mg- 19x30mg Tablet, film coated 34,751,325 L.L
C10AA05 ORVASTA G Atorvastatin - 40mg 40mg Tablet, film coated 1,170,487 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
J01MA12 OXALEV G Levofloxacin - 500mg 500mg Tablet, film coated 791,523 L.L
J01MA12 OXALEV G Levofloxacin - 500mg 500mg Tablet, film coated 565,758 L.L
L04AA37 OLUMIANT B Baricitinib - 2mg 2mg Tablet, film coated 68,053,864 L.L
L04AA37 OLUMIANT B Baricitinib - 4mg 4mg Tablet, film coated 68,053,864 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 10mg 10mg Tablet, film coated 710,893 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 10mg 10mg Tablet, film coated 526,786 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 888,280 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 20mg 20mg Tablet, film coated 667,890 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 920,532 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 40mg 40mg Tablet, film coated 721,643 L.L
C10BA05 OTOREZA G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 908,438 L.L
C10BA05 OTOREZA 10/10 G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 454,219 L.L
C10BA05 OTOREZA 10MG/20MG G Atorvastatin - 20mg, Ezetimibe - 10mg Tablet, film coated 858,715 L.L
C10BA05 OTOREZA 10MG/40MG G Atorvastatin - 40mg, Ezetimibe - 10mg Tablet, film coated 1,144,954 L.L
M04AA03 OXUBAT 120 G Febuxostat - 120mg 120mg Tablet, film coated 1,549,002 L.L
M04AA03 OXUBAT 80 G Febuxostat - 80mg 80mg Tablet, film coated 1,549,002 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 40mg, Hydrochlorothiazide - 25mg Tablet, film coated 653,107 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 40mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 653,107 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 25mg Tablet, film coated 628,918 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 628,918 L.L
M05BA07 OSTERAL G Risedronate sodium - 35mg 35mg Tablet, film coated 511,940 L.L
C09DB02 OLMENOR COMBI G Olmesartan medoxomil - 20mg, Amlodipine - 5mg Tablet, film coated 679,984 L.L
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