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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
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 40mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 653,107 L.L
H02AB02 DEXAMETHASONE MEDIS G Dexamethasone Phosphate - 4mg/1ml 4mg/1ml Injectable solution 1,154,361 L.L
J02AC01 PANZIMOL G Fluconazole - 150mg 150mg Capsule, hard 428,686 L.L
L01BC07 AZACITIDINE ARROW G Azacitidine - 25mg/ml 25mg/ml Injectable suspension 10,967,854 L.L
M03BC51 MUSCEROL EXTRA G Caffeine - 15mg, Paracetamol - 450mg, Orphenadrine citrate - 35mg Tablet, scored 267,489 L.L
N02BE71 PYRETHAL G Paracetamol - 200mg, Phenobarbital - 20mg Suppository 147,183 L.L
N05AH04 SEROPINE XR 300 G Quetiapine fumarate - 300mg 300mg Tablet, extended release 4,744,660 L.L
R03DC03 MONTELUKAST ARROW LAB G Montelukast (sodium) - 4mg 4mg Tablet, chewable 851,996 L.L
S01EE04 TRAVOPROST BIOGARAN G Travoprost - 40mcg/ml 40mcg/ml Drops solution 564,414 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 2,557,140 L.L
A10BA02 DIANORM XR 500 G Metformin HCl - 500mg 500mg Tablet, film coated, extended release 349,399 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 176,974 L.L
C07AG01 LABETALOL HYDROCHLORIDE INJECTION G Labetalol HCl - 100mg/20ml 100mg/20ml Injectable solution 2,955,110 L.L
J01DD08 FIXIM G Cefixime (trihydrate) - 200mg 200mg Capsule 890,968 L.L
J02AC01 STABILANOL G Fluconazole - 150mg 150mg Capsule 254,557 L.L
L01BC07 AZACITIDINE EVER PHARMA G Azacitidine - 100mg/100ml 25mg/ml Injectable powder for suspension 10,967,854 L.L
M03BC51 MUSCEROL 3 G Paracetamol - 450mg, Orphenadrine citrate - 35mg, Ibuprofen - 200mg Tablet, film coated 593,850 L.L
N05AH04 QUETIAPINE BIOGARAN L.P. G Quetiapine fumarate - 50mg 50mg Tablet, prolonged release 1,010,570 L.L
N06DA03 RIVASTIGMINE ARROW G Rivastigmine - 4.5mg 4.5mg Capsule 842,589 L.L
R03DC03 MONTELUKAST-SANDOZ G Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,139,034 L.L
S01EE05 TAFLUPRO G Tafluprost - 0.0015% 0.0015% Solution 1,912,288 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 L.L
A10BA02 DIANORM XR 500 G Metformin HCl - 500mg 500mg Tablet, film coated, extended release 349,399 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 137,902 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 25mg Tablet, film coated 628,918 L.L
H02AB04 LISAMETHYLE G Methylprednisolone sodium succinate - 40mg/2ml 40mg/2ml Injectable powder for solution+diluent 7,905,545 L.L
J01DD08 MUREX 200 G Cefixime - 200mg 200mg Capsule 430,030 L.L
J02AC01 UNAZOL G Fluconazole - 150mg 150mg Capsule 149,742 L.L
L01BC07 AZACITIDINE NEAPOLIS G Azacitidine - 100mg 100mg Injectable lyophilised powder 9,401,575 L.L
N02BG06 NEO-PAN G Nefopam HCl - 20mg/ml 20mg/ml Injectable solution 494,534 L.L
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