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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
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 344,754 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
A07AA02 MEDISTAN G Nystatin - 200.000IU 200.000IU Lozenge 418,511 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 2000IU 2000IU Injectable powder for solution+solvent 286,711,575 L.L
B01AB05 PARINOX 20 BioTech Enoxaparin sodium - 2000IU (20mg)/0.2ml 2000IU (20mg)/0.2ml Injectable solution 188,138 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 2000IU Anti-XA/0.2ml 2000IU Anti-XA/0.2ml Injectable solution 1,105,982 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 2000IU Anti-XA/0.2ml 2000IU Anti-XA/0.2ml Injectable solution 388,370 L.L
B01AB05 ENOMEX BioTech Enoxaparin sodium - 2000U Anti-Xa/0.2ml 2000U Anti-Xa/0.2ml Injectable solution 396,754 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 2000UI/ml 2000UI/ml Injectable solution 7,849,606 L.L
B05AA01 VIALEBEX BioHuman Albumin human - 200g/L 200g/L Injectable solution 3,417,391 L.L
H05BA01 MIACALCIC 200 UI/ACTUATION B Calcitonin (salmon synthetic) - 200IU/actuation 200IU/actuation Solution 5,399,559 L.L
A02BB01 CYTOTEC B Misoprostol - 200mcg 200mcg Tablet 737,770 L.L
A02BB01 MISOFAR G Misoprostol - 200mcg 200mcg Tablet 1,546,763 L.L
N02AB03 ABSTRAL B Fentanyl (citrate) - 200mcg 200mcg Tablet 5,261,143 L.L
R03BA02 AERONIDE G Budesonide - 200mcg 200mcg Capsule, inhalation 1,150,329 L.L
B01AC27 UPTRAVI B Selexipag - 200mcg 200mcg Tablet, film coated 275,097,581 L.L
B01AC27 UPTRAVI B Selexipag - 200mcg 200mcg Tablet, film coated 613,462,617 L.L
N05CM18 PRECEDEX (DEXMEDETOMIDINE) B Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable solution 19,441,512 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 9,340,433 L.L
N05CM18 PROXIDA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 1,771,184 L.L
R03BA02 BUDECORT 200 G Budesonide - 200mcg/actuation 200mcg/actuation Metered dose inhaler 808,993 L.L
M01AE01 ADVIL B Ibuprofen - 200mg 200mg Tablet 321,178 L.L
M01AE01 ADVIL LIQUI-GELS B Ibuprofen - 200mg 200mg Capsule 464,970 L.L
M01AE01 CAPTAIN G Ibuprofen - 200mg 200mg Capsule, soft gelatin 383,955 L.L
L01ED01 XALKORI B Crizotinib - 200mg 200mg Capsule 347,644,061 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
A07AA11 NORMIX TAB B Rifaximin alpha - 200mg 200mg Tablet, film coated 827,807 L.L
A07AA12 DIFICLIR B Fidaxomicin - 200mg 200mg Tablet, film coated 130,192,063 L.L
A07AX03 FUROXYL G Nifuroxazide - 200mg 200mg Capsule 366,037 L.L
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