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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
A10BD21 ENFORZA B Saxagliptin HCl - 5mg, Dapagliflozin - 10mg Tablet, film coated 6,072,824 L.L
N02BE01 EFFERALGAN B Paracetamol - 500mg 500mg Tablet, effervescent scored 129,009 L.L
C03AA03 ESIDREX B Hydrochlorothiazide - 25mg 25mg Tablet 380,115 L.L
J07BC01 ENGERIX-B 20 B Hepatitis B, purified antigen - 20mcg/ml 20mcg/ml Injectable suspension 1,652,926 L.L
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
B01AF02 ELIQUIS B Apixaban - 5mg 5mg Tablet, film coated 4,183,603 L.L
B01AF02 ELIQUIS B Apixaban - 2.5mg 2.5mg Tablet, film coated 4,183,603 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 75mg 75mg Capsule, sustained release 732,394 L.L
A07BA51 EUCARBON B Rhubarbe - 25mg, Sulfur - 50mg, Senna - 105mg, Vegetal charcoal - 180mg Tablet 795,555 L.L
B02AA02 EXACYL B Tranexamic acid - 500mg/5ml 500mg/5ml Injectable solution 748,520 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 150mg 150mg Capsule, sustained release 817,056 L.L
N02BE01 EFFERALGAN B Paracetamol - 1g 1g Tablet, film coated 129,009 L.L
L01AA01 ENDOXAN B Cyclophosphamide (monohydrate) - 500mg 500mg Injectable powder for solution 764,646 L.L
D10AD53 EPIDUO B Adapalene - 0.1%, Benzoyl peroxide - 2.5% Gel 2,088,331 L.L
D10AD53 EPIDUO FORTE B Adapalene - 0.3%, Benzoyl peroxide - 2.5% Gel 2,201,214 L.L
S01BC04 EDOLFENE B Flurbiprofen sodium - 0.03% 0.03% Drops solution 388,370 L.L
D10AF02 ERYFLUID B Erythromycin base - 40mg/ml 4% Lotion 486,471 L.L
D10AF02 ERYFLUID B Erythromycin base - 4% 4% Lotion 486,471 L.L
N02BE01 EFFERALGAN B Paracetamol - 3% 3% Solution 163,949 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) TWIN BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
N02BE01 EFFERALGAN B Paracetamol - 1g 1g Tablet, effervescent 129,009 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) SINGLE BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
D11AH02 ELIDEL B Pimecrolimus - 10mg/g 1% Cream 1,780,591 L.L
M03AC09 ESMERON B Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 4,949,372 L.L
M03AC09 ESMERON B Rocuronium bromide - 50mg/5ml 50mg/5ml Injectable solution 4,750,483 L.L
C09CA09 EDARBI B Azilsartan medoxomil - 40mg 40mg Tablet 1,846,440 L.L
C09CA09 EDARBI B Azilsartan medoxomil - 80mg 80mg Tablet 2,023,827 L.L
L01BB06 EVOLTRA B Clofarabine - 1mg/ml 1mg/ml Injectable concentrate for solution 91,416,937 L.L
L01BC02 EFUDIX B Fluorouracil - 5% 5% Cream 671,921 L.L
N06DA03 EXELON TRANSDERMAL PATCH 10 B Rivastigmine - 9.5mg/24h 9.5mg/24h Patch 2,457,888 L.L
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