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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
S01ED51 XALACOM B Timolol (maleate) - 6.8mg/ml, Latanoprost - 50?g/ml Drops solution 510,660 L.L
S01EE01 XALATAN B Latanoprost - 50mcg/ml 50mcg/ml Drops solution 704,173 L.L
N05AX12 XALIPRO G Aripiprazole - 10mg 10mg Tablet 2,123,271 L.L
N05AX12 XALIPRO G Aripiprazole - 15mg 15mg Tablet 2,418,917 L.L
N05AX12 XALIPRO G Aripiprazole - 5mg 5mg Tablet 1,746,995 L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule 347,644,061 L.L
L01ED01 XALKORI B Crizotinib - 200mg 200mg Capsule 347,644,061 L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule L.L
N05BA12 XANAX B Alprazolam - 0.5mg 0.5mg Tablet 477,064 L.L
B01AF01 XARELTO B Rivaroxaban - 2.5mg 2.5mg Tablet, film coated 4,045,168 L.L
B01AF01 XARELTO B Rivaroxaban - 15mg 15mg Tablet, film coated 4,440,862 L.L
B01AF01 XARELTO B Rivaroxaban - 20mg 20mg Tablet, film coated 4,440,862 L.L
B01AF01 XARELTO B Rivaroxaban - 10mg 10mg Tablet, film coated 1,588,892 L.L
G04CA01 XATRAL XL B Alfuzosin HCl - 10mg 10mg Tablet, prolonged release 1,061,636 L.L
B01AF01 XAVIRAN G Rivaroxaban - 15mg 15mg Tablet, film coated 952,208 L.L
B01AF01 XAVIRAN G Rivaroxaban - 20mg 20mg Tablet, film coated 952,208 L.L
B01AF01 XAVIRAN G Rivaroxaban - 10mg 10mg Tablet, film coated 606,649 L.L
L04AA29 XELJANZ B Tofacitinib - 5mg 5mg Tablet 80,685,473 L.L
L04AA29 XELJANZ XR B Tofacitinib - 11mg 11mg Tablet, extended release 78,687,316 L.L
L01BC06 XELODA B Capecitabine - 500mg 500mg Tablet, film coated 17,946,398 L.L
D07AC13 XEMADERM G Mometasone furoate - 0.1% 0.1% Cream 335,961 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
M03AX01 XEOMIN BioTech Clostridium botulinum type A neurotoxin complex - 100 units LD50 100 units LD50 Injectable powder for solution 20,517,541 L.L
M03AX01 XEOMIN BioTech Clostridium botulinum type A neurotoxin complex - 50 units LD50 50 units LD50 Injectable powder for solution 11,920,109 L.L
J01DD15 XEVANEER G Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,308,903 L.L
J01DD15 XEVANEER G Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 686,704 L.L
J01DD15 XEVANEER G Cefdinir - 300mg 300mg Capsule 1,350,562 L.L
M05BX04 XGEVA BioTech Denosumab - 120mg 120mg Injectable solution 33,545,669 L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 5mg Tablet 3,867,041 L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet 3,006,579 L.L
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