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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
N05AN01 MANICARB SR-400 G Lithium carbonate - 400mg 400mg Tablet, prolonged release 1,431,192 L.L
N06DX01 EXENTA G Memantine HCl - 10mg 10mg Tablet, film coated 1,057,156 L.L
R03DC03 ROMILAST G Montelukast (sodium) - 4mg 4mg Tablet, mouth dissolving 405,840 L.L
S01EE01 XALAPROST G Latanoprost - 0.005% w/v 0.005% w/v Drops solution 421,967 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 613,662 L.L
C10AA05 APO-ATORVASTATIN G Atorvastatin (calcium) - 10mg 10mg Tablet 889,624 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 500mg 500mg Capsule 564,414 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 7,529,090 L.L
J05AF10 APO-ENTECAVIR G Entecavir - 0.5mg 0.5mg Tablet 28,943,287 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable concentrated solution 2,123,271 L.L
L01XG01 BORTEZOMIB ACCORD G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 13,007,658 L.L
L04AX04 LENALIDOMIDE STRAGEN G Lenalidomide - 10mg 10mg Capsule 33,314,752 L.L
M04AA03 FEBUXOSTAT ARROW G Febuxostat - 120mg 120mg Tablet, film coated 1,084,481 L.L
N02BF02 NEUREXAL G Pregabalin - 150mg 150mg Capsule 754,856 L.L
N06DX01 MEMANTINE ARROW LAB G Memantine HCl - 10mg 10mg Tablet, film coated, scored 1,404,315 L.L
R03DC03 UNICAST G Montelukast (sodium) - 4mg 4mg Tablet, chewable 783,460 L.L
S01EE01 MONOPROST G Latanoprost - 50mcg/ml 50mcg/ml Drops solution 1,187,957 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 598,051 L.L
A10BD19 EMPAGLINE G Empagliflozin - 25mg, Linagliptin - 5mg Tablet, film coated 2,237,050 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 2,576,338 L.L
B05BC01 MANNITOL 20% INJECTION USP G Mannitol - 20% 20% Injectable solution 374,633 L.L
C01EB15 CARMETADIN G Trimetazidine - 35mg 35mg Tablet, film coated, modified release 631,606 L.L
C09AA05 ACURIL G Ramipril - 10mg 10mg Tablet 810,337 L.L
C10AA05 ASCOVA G Atorvastatin (calcium) - 10mg 10mg Tablet, scored 1,126,268 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 500mg 500mg Capsule 254,690 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 183,019 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 32,224,230 L.L
L01CE02 IRNOCAM 40 G Irinotecan HCl - 40mg/2ml 40mg/2ml Injectable solution 908,694 L.L
L01XG01 BORTEZOMIB NEAPOLIS G Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution 14,169,600 L.L
L04AX04 LENOMA G Lenalidomide - 10mg 10mg Capsule, hard 14,449,637 L.L
    ...
    189
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