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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
R03AL02 COMBIVENT B Salbutamol (sulfate) - 2.5mg/2.5ml, Ipratropium bromide - 500mcg/2.5ml Inhaltion solution with nebuliser 745,833 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
G04CA02 OMNIC OCAS B Tamsulosin HCl - 0.4mg 0.4mg Tablet, film coated, prolonged release 866,778 L.L
L01EX10 RYDAPT B Midostaurin - 25mg 25mg Capsule, soft 581,645,553 L.L
L04AA42 MAYZENT B Siponimod - 2mg 2mg Tablet, film coated 124,258,444 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 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
D10AF51 DUAC ONCE DAILY B Clindamycin (phosphate) - 1%, Benzoyl peroxide - 5% Gel 1,658,302 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
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B05DB DIANEAL PD4 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l 1.36% Injectable solution 1,163,270 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg/250ml 400mg/250ml Injectable solution 9,052,935 L.L
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B03AB09 FERPLEX B Iron trivalent (ferric proteinsuccinylate) - 800mg 800mg Solution 1,202,739 L.L
B05DB DIANEAL PD4 CYCLER 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l Injectable solution 1,150,329 L.L
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B03AC VENOFER I.V. B Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable concentrated solution 3,594,779 L.L
B05DB DIANEAL PD4 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,163,270 L.L
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C09CA08 VOTUM B Olmesartan medoxomil - 10mg 10mg Tablet, film coated 753,896 L.L
J01MA17 KINODROX B Prulifloxacin - 600mg 600mg Tablet, film coated 1,407,835 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
B05DB DIANEAL PD4 CYCLER 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,150,329 L.L
C05CA53 DAFLON B Hesperidin - 100mg, Diosmin - 900mg Tablet, film coated 1,256,493 L.L
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