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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
N05AX12 XALIPRO G Aripiprazole - 5mg 5mg Tablet 1,746,995 L.L
N05AX12 ABILIFY MAINTENA B Aripiprazole - 400mg 400mg Injectable powder for suspension, prolonged release+solvent 29,491,998 L.L
N05AX13 INVEGA B Paliperidone - 9mg 9mg Tablet, extended release 5,825,557 L.L
N05AX13 INVEGA B Paliperidone - 3mg 3mg Tablet, extended release 5,386,121 L.L
N05AX13 INVEGA B Paliperidone - 6mg 6mg Tablet, extended release 5,825,557 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 100mg 100mg Injectable suspension, prolonged release 18,342,148 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 75mg 75mg Injectable suspension, prolonged release 14,659,577 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 50mg 50mg Injectable suspension, prolonged release 9,661,754 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 150mg 150mg Injectable suspension, prolonged release 26,434,190 L.L
N05AX13 TREVICTA B Paliperidone - 175mg 175mg Injectable suspension, prolonged release 33,673,469 L.L
N05AX13 TREVICTA B Paliperidone - 263mg 263mg Injectable suspension, prolonged release 39,162,480 L.L
N05AX13 TREVICTA B Paliperidone - 350mg 350mg Injectable suspension, prolonged release 48,204,866 L.L
N05AX13 TREVICTA B Paliperidone - 525mg 525mg Injectable suspension, prolonged release 72,306,028 L.L
N05AX13 BYANNLI B Paliperidone - 1000mg 1000mg Injectable suspension, prolonged release 135,844,746 L.L
N05AX13 BYANNLI B Paliperidone - 700mg 700mg Injectable suspension, prolonged release 93,221,562 L.L
N05AX15 REAGILA G Cariprazine HCl - 1.5mg 1.5mg Capsule, hard 6,394,003 L.L
N05AX15 REAGILA G Cariprazine HCl - 3mg 3mg Capsule, hard 6,394,003 L.L
N05AX15 REAGILA G Cariprazine HCl - 4.5mg 4.5mg Capsule, hard 6,394,003 L.L
N05AX15 REAGILA G Cariprazine - 6mg 6mg Capsule, hard 6,394,003 L.L
N05AX16 REXULTI B Brexpiprazole - 4mg 4mg Tablet, film coated 13,433,051 L.L
N05AX16 REXULTI B Brexpiprazole - 3mg 3mg Tablet, film coated 13,433,051 L.L
N05AX16 REXULTI B Brexpiprazole - 2mg 2mg Tablet, film coated 13,433,051 L.L
N05AX16 REXULTI B Brexpiprazole - 1mg 1mg Tablet, film coated 13,433,051 L.L
N05BA01 VALIUM B Diazepam - 5mg 5mg Tablet, scored 200,233 L.L
N05BA01 DIAZEPAM RENAUDIN G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 514,692 L.L
N05BA01 KRATIUM G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 537,537 L.L
N05BA02 PSICODEX G Chlordiazepoxide - 5mg 5mg Tablet 152,302 L.L
N05BA06 LORAZEPAM G Lorazepam - 1mg 1mg Tablet, scored 325,082 L.L
N05BA06 LORAZEPAM G Lorazepam - 2mg 2mg Tablet, scored 485,063 L.L
N05BA08 LEXOTANIL B Bromazepam - 3mg 3mg Tablet, scored 413,903 L.L
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