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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
A16AB04 FABRAZYME BioTech Agalsidase beta - 35mg 35mg Injectable powder for concentrate for solution 295,038,213 L.L
A16AB04 FABRAZYME BioTech Agalsidase beta - 35mg 35mg Injectable powder for concentrate for solution L.L
M05BA04 FOSAMAX 70MG ONCE WEEKLY B Alendronate - 70mg 70mg Tablet 1,988,887 L.L
M05BB03 FOSAVANCE B Alendronic acid (sodium alendronate) - 70mg, Colecalciferol - 5600IU Tablet 1,988,887 L.L
R05CB06 FLUIBRON G Ambroxol - 15mg/5ml 15mg/5ml Syrup 459,594 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
J01DD08 FIXIM G Cefixime (trihydrate) - 200mg 200mg Capsule 890,968 L.L
J01DD08 FIXIM G Cefixime (trihydrate) - 400mg 400mg Capsule 1,435,224 L.L
J01DD02 FORTECARE G Ceftazidime - 1g 1g Injectable powder for solution 10,011,695 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 342,680 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 5mg/5ml 5mg/5ml Solution 170,668 L.L
G04B FONCITRIL 4000 B Citric acid - 1.189g, Potassium Citrate - 1.73g, Sodium citrate - 1.845g Granules 1,613,955 L.L
A03CA02 FLUDINIUM G Clidinium bromide - 2.5mg, Trifluoperazine HCl - 1mg Capsule 386,515 L.L
A10BK01 FORXIGA B Dapagliflozin - 10mg 10mg Tablet, film coated 2,927,964 L.L
L02BX02 FIRMAGON B Degarelix (acetate) - 120mg 120mg Injectable powder for solution+diluent 24,325,802 L.L
L02BX02 FIRMAGON B Degarelix (acetate) - 80mg 80mg Injectable powder for solution+diluent 13,361,635 L.L
G01AC05 FLUOMIZIN B Dequalinium chloride - 10mg 10mg Tablet 775,397 L.L
R06AX FRENALER CORT G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Syrup 741,801 L.L
R06AX FRENALER CORT G Desloratadine - 5mg, Betamethasone - 0.6mg Tablet, film coated 632,950 L.L
S01CA01 FRAKIDEX B Dexamethasone disodium phosphate - 0.1g/100g, Framycetin sulfate - 0.5g/100g Ointment 141,103 L.L
M02AA15 FLECTOR E.P TISSUGEL B Diclofenac (epolamine) - 1% 1% Patch 1,204,083 L.L
M01AB05 FLECTOR E.P B Diclofenac (epolamine) - 50mg 50mg Granules 503,941 L.L
D04AA13 FENISTIL B Dimethindene maleate - 1mg/g 1mg/g Gel 196,201 L.L
A03FA03 FARCOTILIUM G Domperidone - 10mg 10mg Capsule, soft gelatin 146,479 L.L
A03FA03 FARCOTILIUM G Domperidone - 5mg/5ml 5mg/5ml Suspension 115,570 L.L
J01AA02 FARMODOXI G Doxycycline (hyclate) - 100mg 100mg Tablet 310,428 L.L
D11AX16 FLOREXA G Eflornithine (HCl) - 11.5% 11.5% Cream 3,527,587 L.L
A10BK03 FLORIANCE 10 G Empagliflozin - 10mg 10mg Tablet, film coated 1,791,790 L.L
A10BK03 FLORIANCE 25 G Empagliflozin - 25mg 25mg Tablet, film coated 1,791,790 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 1000IU 1000U (50U/ml) Injectable powder for solution+solvent 76,827,220 L.L
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