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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
G03GA06 PUREGON BioHuman Follitropin beta - 600IU/0.72ml 600IU/0.72ml Injectable solution 24,121,923 L.L
G03GA08 OVITRELLE BioHuman Choriogonadotropin Alfa - 250mcg/0.5ml 250mcg/0.5ml Injectable solution 4,145,754 L.L
G03GA09 ELONVA BioHuman Corifollitropin alfa - 100mcg/0.5ml 100mcg/0.5ml Injectable solution 35,131,802 L.L
G03GA30 PERGOVERIS BioHuman Follitropin alfa - 150IU, Lutropin Alfa - 75IU Injectable powder for solution+diluent 6,523,011 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 2.5g/50ml 2.5g/50ml Injectable solution 17,011,323 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 2.5g/25ml 10% Injectable solution 23,611,268 L.L
J06BA02 ARAGAM BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 38,549,017 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 40,685,649 L.L
J06BA02 GAMUNEX-C BioHuman Human normal immunoglobulin G - 10% 10% Injectable solution 39,990,287 L.L
J06BA02 IG VENA BioHuman Human normal immunoglobulin - 5g/100ml 5g/100ml Injectable solution 28,622,366 L.L
J06BA02 IMMUNOREL BioHuman Human normal immunoglobulin - 5g/100ml 5% Injectable solution 29,700,912 L.L
J06BA02 IMMUNOREL BioHuman Human normal immunoglobulin - 2.5g/50ml 5% Injectable solution 14,850,456 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution 35,639,835 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 37,672,334 L.L
J06BA02 OCTAGAM 10% BioHuman Human normal immunoglobulin G - 10% 5g/50ml Injectable solution 37,672,334 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 5g/50ml 10% Injectable solution 42,577,976 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 74,469,269 L.L
C09BA04 PRETERAX ARGININE B Perindopril arginine - 2.5mg, Indapamide - 0.625mg Tablet, film coated 452,875 L.L
D07AC01 DIPROSONE B Betamethasone (dipropionate) - 0.5mg/g 0.05% Cream 291,614 L.L
G04BD08 VESICARE B Solifenacin succinate - 10mg 10mg Tablet, film coated 1,619,330 L.L
M01AC01 BRUXICAM B Piroxicam - 0.5% Drops solution 530,818 L.L
N01BB58 SEPTANEST ADRENALINEE B Articaine HCl - 72mg/1.8ml, Adrenaline (tartrate) - 0.033mg/1.8ml 1/100,000 Injectable solution 2,945,703 L.L
N06AA21 LUDIOMIL B Maprotiline - 10mg 10mg Tablet, sugar coated 867,738 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated L.L
A01AB09 DAKTARIN ORAL B Miconazole nitrate - 20mg/g 20mg/g Gel 377,620 L.L
A06AD11 DUPHALAC B Lactulose - 6.7g/10ml 6.7g/10ml Solution 454,219 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,052,874 L.L
C02AB02 ALDOMET B Methyldopa - 250mg 250mg Tablet, coated 619,853 L.L
C09BA04 BI-PRETERAX ARGININE B Perindopril arginine - 10mg, Indapamide - 2.5mg Tablet, film coated 765,990 L.L
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