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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
L04AX04 SOTIRA G Lenalidomide - 5mg 5mg Capsule 68,908,116 L.L
D03BA SERODASE G Serratiopeptidase - 5mg 5mg Tablet, enteric coated 460,938 L.L
G04BD08 SOLIFAS G Solifenacin succinate - 5mg 5mg Tablet, film coated 971,598 L.L
G04BD08 SOLIFENACINE ARROW G Solifenacin succinate - 5mg 5mg Tablet 952,784 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 1000mg 5mg/1000mg Tablet, film coated 3,156,820 L.L
M05BA08 SIMPLA G Zoledronic acid - 5mg/100ml 5mg/100ml Injectable solution 13,071,402 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 5mg/5ml 5mg/5ml Syrup 210,983 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 850mg 5mg/850mg Tablet, film coated 3,052,874 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 5mg/ml 5mg/ml Drops 287,582 L.L
N02BE01 SULDEX A G Paracetamol - 600mg 600mg Suppository 200,936 L.L
J05AG03 STOVIRENZ G Efavirenz - 600mg 600mg Tablet, film coated 6,857,456 L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
M05BA04 STRONDEX 70 G Alendronate sodium - 70mg 70mg Tablet 1,305,447 L.L
L01EA02 SPRYCEL B Dasatinib - 70mg 70mg Tablet 212,274,841 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 75mg 75mg Injectable solution 194,911,251 L.L
R05CB06 SOLVAMUC SR G Ambroxol - 75mg 75mg Capsule 276,448 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer carbonate - 800mg 800mg Tablet, film coated 8,645,754 L.L
M01AE03 SOLKET G Ketoprofen Lysine salt - 80mg 80mg Powder for solution 636,981 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 80mg 80mg Tablet, scored 288,926 L.L
M04AA03 STABURIC G Febuxostat - 80mg 80mg Tablet, film coated 1,355,489 L.L
A10BA02 SIOFOR G Metformin HCl - 850mg 850mg Tablet, film coated 174,700 L.L
G04CA04 SILOSIN B Silodosine - 8mg 8mg Capsule 1,927,454 L.L
G04CA04 SILODOSINE ARROW G Silodosine - 8mg 8mg Capsule 732,394 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 8mg 8mg Capsule 555,007 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution 151,777,679 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 90mg 90mg Injectable solution 48,383,450 L.L
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