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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
J01DD08 WINEX G Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Suspension 700,142 L.L
J02AC01 MYXEN G Fluconazole - 150mg 150mg Tablet 255,970 L.L
L01BC06 CAPECITABINE SPC G Capecitabine - 150mg 150mg Tablet, film coated 4,094,240 L.L
L04AD02 TACROGRAF 0.5 G Tacrolimus - 0.5mg 0.5mg Capsule 7,004,024 L.L
N05AH04 QUETIAPINE BIOGARAN L.P. G Quetiapine fumarate - 300mg 300mg Tablet, prolonged release 1,759,090 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 5mg/5ml 5mg/5ml Syrup 210,983 L.L
A10BA02 METFORKEY G Metformin HCl - 1.000mg 1.000mg Tablet, extended release 374,932 L.L
A15 DESARROL G Cyproheptadine HCl - 0.2mg/ml, L-Arginine L-Aspartate - 25mg/ml, L-Carnitine - 50mg/ml Solution 1,007,882 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 179,272 L.L
C07AB12 NEBIVOLOL BIOGARAN G Nebivolol HCl - 5mg 5mg Tablet, scored 529,474 L.L
D01AC08 KETOCONAZOLE KORHISPANA G Ketoconazole - 2% 2% Gel 599,354 L.L
H02AB02 DEXAMETHASON-PANPHARMA G Dexamethasone - 5mg/1ml 5mg/1ml Injectable solution 368,213 L.L
J02AC01 ORAMAX G Fluconazole - 150mg 150mg Capsule 170,668 L.L
M03BC51 MUSCEROL 2 G Paracetamol - 450mg, Orphenadrine (citrate) - 35mg Tablet, scored 177,899 L.L
N05AH04 REZAL XR G Quetiapine fumarate - 300mg 300mg Tablet, extended release 2,535,831 L.L
R03DC03 LUKAST G Montelukast (sodium) - 4mg 4mg Tablet, chewable 783,460 L.L
S01EE04 TRAVONORM G Travoprost - 0.004% 0.004% Drops 564,414 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 355,798 L.L
A15A DYNAMOGEN G Arginine Aspartate - 1g/10ml, Glutodine (Cyproheptadine ?-ketoglutarate) - 3mg/10ml Solution 1,019,976 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 160,885 L.L
C07AB12 NEVILOC G Nebivolol HCl - 5mg 5mg Tablet 476,104 L.L
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
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