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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
L01ED01 XALKORI B Crizotinib - 200mg 200mg Capsule 347,644,061 L.L
A04AD GRAVOL B Dimenhydrinate - 100mg 100mg Suppository 294,302 L.L
G04BD09 SPASMEX B Trospium chloride - 30mg 30mg Tablet, film coated 2,564,051 L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard 490,837,809 L.L
N02AJ06 EFFERALGAN CODEINE B Paracetamol - 500mg, Codeine phosphate - 30mg Tablet, effervescent scored 215,015 L.L
R06AX13 CLARITINE B Loratadine (micronised) - 5mg/5ml 5mg/5ml Syrup 430,030 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 75mg 75mg Capsule, hard 3,205,064 L.L
C09BA03 ZESTORETIC B Lisinopril (dihydrate) - 20mg, Hydrochlorothiazide - 12.5mg Tablet 663,858 L.L
G04BD09 SPASMEX B Trospium chloride - 30mg 30mg Tablet, film coated 2,564,051 L.L
L01ED04 ALUNBRIG B Brigatinib - 30mg 30mg Tablet, film coated 119,936,249 L.L
N02AJ06 EFFERALGAN CODEINE B Paracetamol - 500mg, Codeine phosphate - 30mg Tablet, film coated 215,015 L.L
L01BC07 VIDAZA B Azacitidine - 100mg 100mg Injectable lyophilised powder L.L
A10BD15 XIGDUO XR B Metformin HCl XR - 1000mg, Dapagliflozin - 10mg Tablet 3,006,579 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 75mg 75mg Capsule, hard 1,603,204 L.L
C01EB18 RANEXA B Ranolazine - 375mg 375mg Tablet, prolonged release 3,985,837 L.L
G04BD12 BETMIGA B Mirabegron - 50mg 50mg Tablet, prolonged release 3,758,727 L.L
L01ED04 ALUNBRIG B Brigatinib - 90mg 90mg Tablet, film coated 359,811,073 L.L
M01AE01 ALGIFAST 400 B Ibuprofen Lysine - 400mg 400mg Powder for suspension 473,033 L.L
R01BA53 AURIMEL B Phenylephrine HCl - 5mg/5ml, Sodium citrate - 325mg/5ml, Carbinoxamine maleate - 2mg/5ml, Dextromethorphan HBr - 5mg/5ml Syrup 319,963 L.L
A05AA02 URSOFALK B Ursodeoxycholic acid - 250mg 250mg Capsule 2,823,413 L.L
C01EB18 RANEXA B Ranolazine - 500mg 500mg Tablet, prolonged release 3,985,837 L.L
C09BA04 BI-PRETERAX ARGININE B Perindopril arginine - 5mg, Indapamide - 1.25mg Tablet, film coated 452,875 L.L
G04BE03 VIAGRA B Sildenafil (citrate) - 50mg 50mg Tablet, film coated 2,089,675 L.L
L01ED04 ALUNBRIG B Brigatinib - 180mg 180mg Tablet, film coated 474,793,952 L.L
M01AE01 ALGIFAST PEDIATRIC B Ibuprofen Lysine - 20mg/ml 20mg/ml Suspension 393,746 L.L
N03AX18 VIMPAT B Lacosamide - 50mg 50mg Tablet, film coated 1,024,008 L.L
R06AX22 EBASTEL B Ebastine - 10mg 10mg Tablet, film coated 722,987 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 1,603,204 L.L
C01EB18 RANEXA B Ranolazine - 750mg 750mg Tablet, prolonged release 3,985,837 L.L
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