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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
M02AA15 OLFEN G Diclofenac sodium (diethylamine) - 1% 1% Gel 268,769 L.L
M04AA03 OXUBAT 120 G Febuxostat - 120mg 120mg Tablet, film coated 1,549,002 L.L
M04AA03 OXUBAT 80 G Febuxostat - 80mg 80mg Tablet, film coated 1,549,002 L.L
M05BA04 OREK G Alendronate - 70mg 70mg Tablet, coated 2,404,838 L.L
M05BA04 OSTEOMED G Alendronic acid (sodium alendronate) - 70mg 70mg Tablet, scored 950,929 L.L
M05BA07 OSTERAL G Risedronate sodium - 35mg 35mg Tablet, film coated 511,940 L.L
M05BX OSSOPAN B Osseine-hydroxyapatite complex - 800mg 800mg Tablet, film coated 1,142,266 L.L
N01BB58 ORABLOC G Articaine HCl - 4%, Epinephrine (tartrate) - 1/100.000 Injectable solution 2,308,721 L.L
N02AA05 OXYNORM B Oxycodone HCl - 5mg 5mg Capsule, hard 1,991,575 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg 10mg Capsule, hard 3,988,525 L.L
N02AA05 OXYNORM B Oxycodone HCl - 20mg 20mg Capsule, hard 7,634,958 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
N02AA05 OXYCODONE RENAUDIN G Oxycodone HCl - 10mg/10ml 10mg/10ml Injectable solution 2,432,355 L.L
N05AG02 ORAP FORTE B Pimozide - 4mg 4mg Tablet 329,241 L.L
N05AH03 OLANZAMED G Olanzapine - 5mg 5mg Tablet 665,522 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 5mg 5mg Tablet 670,577 L.L
N05AH03 OLANZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,316,966 L.L
N05AH03 OLIZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,466,580 L.L
N05AH03 OLANZAMED G Olanzapine - 20mg 20mg Tablet 3,941,938 L.L
N05AH03 OLANZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,329,327 L.L
N05AH03 OLIZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,598,096 L.L
N05AH03 OLANZAMED G Olanzapine - 10mg 10mg Tablet 902,294 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 10mg 10mg Tablet 822,432 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 7.5mg 7.5mg Tablet 822,432 L.L
N06AB03 OXETINE 20 G Fluoxetine (HCl) - 20mg 20mg Tablet, coated 362,837 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Drops 241,892 L.L
R01AA07 OTRIVIN MENTHOL 0.1% B Xylometazoline HCl - 0.1% 0.1% Drops 387,027 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Drops 181,419 L.L
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