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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
C10AA05 LIPONORM G Atorvastatin (calcium) - 40mg 40mg Tablet, film coated 1,491,665 L.L
G04BE08 TYRA G Tadalafil - 5mg 5mg Tablet, film coated 3,566,558 L.L
J01MA12 LEFLUMAX G Levofloxacin (hemihydrate) - 500mg 500mg Tablet, film coated 752,552 L.L
L01EM03 PIQRAY B Alpelisib - 200mg 200mg Tablet, film coated 359,195,954 L.L
A10BK01 DIVINUS G Dapagliflozin propanediol - 5mg 5mg Tablet, film coated 2,145,848 L.L
C09CA03 VIOSTAN 160 G Valsartan - 160mg 160mg Tablet, film coated 668,082 L.L
C10AA05 LORVAST G Atorvastatin (calcium) - 40mg 40mg Tablet, film coated 1,253,805 L.L
G04BE08 VIVIDA 5 G Tadalafil - 5mg 5mg Tablet, film coated 2,559,700 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated L.L
A10BK01 FORXIGA B Dapagliflozin - 10mg 10mg Tablet, film coated 2,927,964 L.L
C09CA03 VIOSTAN 320 G Valsartan - 320mg 320mg Tablet, film coated 1,338,467 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg 250mg Tablet, film coated 349,399 L.L
J01MA12 LEVOKEY 500 G Levofloxacin (hemihydrate) - 500mg 500mg Tablet, film coated 141,103 L.L
L04AA32 OTEZLA B Apremilast - 4x10mg- 4x20mg- 19x30mg Tablet, film coated 34,751,325 L.L
M01AH05 ARCOXIA B Etoricoxib - 60mg 60mg Tablet, film coated 1,685,178 L.L
A10BK01 DIAFLOZIN G Dapagliflozin - 10mg 10mg Tablet, film coated 2,124,167 L.L
C09CA03 VIOSTAN 40 G Valsartan - 40mg 40mg Tablet, film coated 526,786 L.L
C10AA05 ORVASTA G Atorvastatin - 40mg 40mg Tablet, film coated 1,170,487 L.L
G04BE08 DURALIS G Tadalafil - 10mg 10mg Tablet, film coated 1,187,701 L.L
L04AA32 APRIVA STARTER PACK G Apremilast - 10mg, Apremilast - 20mg, Apremilast - 30mg Tablet, film coated 22,154,866 L.L
M01AH05 ARTRIX 60 G Etoricoxib - 60mg 60mg Tablet, film coated 1,054,596 L.L
A10BK01 DIVINUS G Dapagliflozin propanediol - 10mg 10mg Tablet, film coated 2,316,784 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 L.L
C10AA05 TARDELIP G Atorvastatin - 40mg 40mg Tablet, film coated 1,055,876 L.L
J01MA12 LOXOF G Levofloxacin (hemihydrate) - 500mg 500mg Tablet, film coated 141,103 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
M01AH05 CONSORT G Etoricoxib - 60mg 60mg Tablet, film coated 338,648 L.L
A10BK01 ZYGLOR 10 G Dapagliflozin - 10mg 10mg Tablet, film coated 2,039,953 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 L.L
C10AA05 TARDEN G Atorvastatin (calcium) - 40mg 40mg Tablet, film coated 1,055,876 L.L
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