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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
D10AD01 TRETINOIN G Tretinoin - 0.05% 0.05% Solution 623,287 L.L
D10AD04 ROACCUTANE B Isotretinoin - 0.05% 0.05% Gel 932,627 L.L
S01GX02 LEVOPHTA B Levocabastine HCl - 0.5mg/ml 0.05% Suspension 682,672 L.L
S01XA18 RESTASIS B Ciclosporin - 0.5mg/ml 0.05% Emulsion 4,100,063 L.L
S01XA18 RESTASIS B Ciclosporin - 0.5mg/ml 0.05% Emulsion 4,100,063 L.L
S01XA18 DRYFREE G Ciclosporin - 0.05% 0.05% Drops 2,257,655 L.L
S01XA18 ESTAPORIN G Ciclosporin - 0.05% 0.05% Emulsion 2,815,798 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Solution 260,705 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.05% 0.05% Metered dose spray 155,886 L.L
S01BC04 FLUROPTIC G Flurbiprofen sodium - 0.03% w/v 0.03% w/v Drops solution 223,078 L.L
S01BC04 EDOLFENE B Flurbiprofen sodium - 0.03% 0.03% Drops solution 388,370 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
D10AD01 TRETINOIN G Tretinoin - 0.025% 0.025% Solution 564,414 L.L
S01EE06 VYZULTA B Latanoprostene bunod - 0.024% 0.024% Solution 1,948,572 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/ml 0.01g/ml Solution 368,213 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/g 0.01g/g Cream 344,024 L.L
S01EB02 MIOSTAT STERIL INTRAOCULAR B Carbachol - 0.01% 0.01% Solution 8,117,591 L.L
G03CA03 MONTADIOL G Estradiol - 0.01% 0.01% Cream 1,105,982 L.L
D03AX06 BECAPLEX BioTech Becaplermin - 40mg 0.01% Gel 38,029,953 L.L
S01EE01 API-LOPROST G Latanoprost - 0.005% 0.005% Drops 447,500 L.L
S01EE04 TRAVATAN B Travoprost - 40mcg/ml 0.004% Drops solution 806,306 L.L
S01EE04 TRAVONORM G Travoprost - 0.004% 0.004% Drops 564,414 L.L
S01EE05 TAFLUPRO G Tafluprost - 0.0015% 0.0015% Solution 1,912,288 L.L
H01AC01 GENOTROPIN BioTech Somatropin recombinant - 5.3mg/1.15ml 5.3mg/1.15ml Injectable powder for solution+diluent 4,724,854 L.L
M05BA08 ZOLEDRONIC ACID HIKMA G Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrate for solution 9,098,466 L.L
A10BD20 FLORIMET 5/1000 G Metformin - 1000mg, Empagliflozin - 12.5mg Tablet, film coated 1,836,585 L.L
C01EX CARDIOVITEX G Coenzyme Q10 - 300mg, Magnesium oxide - 100mg Tablet 2,822,069 L.L
C09BA04 PRETERAX ARGININE B Perindopril arginine - 2.5mg, Indapamide - 0.625mg Tablet, film coated 452,875 L.L
M01AC01 BRUXICAM B Piroxicam - 0.5% Drops solution 530,818 L.L
C09BA04 BI-PRETERAX ARGININE B Perindopril arginine - 10mg, Indapamide - 2.5mg Tablet, film coated 765,990 L.L
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