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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
S01ED51 COMBISOPT G Timolol maleate - 5mg/ml, Dorzolamide HCl - 20mg/ml Drops solution 935,570 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 10mg Tablet, film coated 4,482,387 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
J01DI54 ZERBAXA B Ceftolozane Sulfate - 1g, Tazobactam (sodium) - 0.5g Injectable powder for concentrate for solution 74,780,802 L.L
N06DA52 MEXAZIL XR 14/10 G Memantine HCl - 14mg, Donepezil HCl - 10mg Capsule 3,432,174 L.L
A06AA01 HUILE DE PARAFFINE G Liquid paraffin - Liquid 207,336 L.L
A10BD19 EMPAGLINE G Empagliflozin - 10mg, Linagliptin - 5mg Tablet, film coated 2,237,050 L.L
J01EE01 PAEDIATRIC CO-TRIMOXAZOLE MIXTURE G Trimethoprim - 40mg/5ml, Sulfamethoxazole - 200mg/5ml Suspension 190,698 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,482,387 L.L
J01EE01 BACTRIM FORTE B Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 344,024 L.L
A10BD19 GLYXAMBI B Linagliptin - 5mg, Empagliflozin - 25mg Tablet, film coated 4,482,387 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 7,529,090 L.L
A10BD19 EMPAGLINE G Empagliflozin - 25mg, Linagliptin - 5mg Tablet, film coated 2,237,050 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 183,019 L.L
M05BA08 ZOLEDRONIC ACID HIKMA G Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrate for solution 9,098,466 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
S01EE05 TAFLUPRO G Tafluprost - 0.0015% 0.0015% Solution 1,912,288 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
S01EE01 API-LOPROST G Latanoprost - 0.005% 0.005% Drops 447,500 L.L
S01EE01 XALAPROST G Latanoprost - 0.005% w/v 0.005% w/v Drops solution 421,967 L.L
D03AX06 BECAPLEX BioTech Becaplermin - 40mg 0.01% Gel 38,029,953 L.L
G03CA03 MONTADIOL G Estradiol - 0.01% 0.01% Cream 1,105,982 L.L
S01EB02 MIOSTAT STERIL INTRAOCULAR B Carbachol - 0.01% 0.01% Solution 8,117,591 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/g 0.01g/g Cream 344,024 L.L
D01AC01 CANESTEN B Clotrimazole - 0.01g/ml 0.01g/ml Solution 368,213 L.L
S01EE06 VYZULTA B Latanoprostene bunod - 0.024% 0.024% Solution 1,948,572 L.L
D10AD01 TRETINOIN G Tretinoin - 0.025% 0.025% Solution 564,414 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
S01BC04 EDOLFENE B Flurbiprofen sodium - 0.03% 0.03% Drops solution 388,370 L.L
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