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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
N03AX14 LEVETIRACETAM ARROW LAB G Levetiracetam - 250mg 250mg Tablet, film coated, breakable 1,243,054 L.L
N06AB03 NEANXETIN G Fluoxetine (HCl) - 20mg 20mg Capsule 422,351 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 342,680 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 203,481 L.L
A02BC05 ESOMEPRAZOLE BIOGARAN G Esomeprazole (magnesium dihydrate) - 40mg 40mg Capsule, gastro-resistant 513,348 L.L
A11CC05 BIO-D3 25000IU G Vitamin D3 - 25000IU 25000IU Capsule 1,130,108 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 4.2g/100ml 4.2g/100ml Injectable solution 742,370 L.L
C07AA05 APO-PROPRANOLOL G Propranolol HCl - 40mg 40mg Tablet, scored 356,118 L.L
C10AB04 LOW-LIP G Gemfibrozil - 600mg 600mg Tablet, film coated 298,333 L.L
D10BA01 CURACNE G Isotretinoin - 5mg 5mg Capsule, soft gelatin 856,028 L.L
G04CA02 TAMSU GENERICON RETARD G Tamsulosin - 0.4mg 0.4mg Capsule, hard, modified release 615,480 L.L
J01MA12 TAVAQUIN 500MG G Levofloxacin - 500mg 500mg Tablet, film coated 787,492 L.L
L03AX03 BCG-MEDAC G BCG seed RIVM derived from seed 1173-P2 - 2x10? to 3x10? viable units Injectable powder for suspension+diluent 18,750,588 L.L
M01AE01 PEDIAFEN G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 200,936 L.L
N02AA01 ACTISKENAN G Morphine sulfate - 20mg 20mg Capsule, immediate release 512,004 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 250mg 250mg Tablet, coated, scored 1,350,562 L.L
N06AB03 OXETINE 20 G Fluoxetine (HCl) - 20mg 20mg Tablet, coated 362,837 L.L
R01AB06 NARIX G Xylometazoline HCl - 90mcg/actuation, Carbocisteine - 900mcg/actuation Spray 518,339 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for injection - Water for injection, irrigation 264,311 L.L
A02BC05 EXONAR G Esomeprazole (magnesium trihydrate) - 40mg 40mg Capsule, delayed release 639,925 L.L
A11CC05 BIO-D3 25000IU G Vitamin D3 - 25000IU 25000IU Capsule 2,147,588 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
C07AA05 BEDRANOL G Propranolol HCl - 40mg 40mg Tablet, film coated 247,267 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 40mg 40mg Tablet, film coated 721,643 L.L
C10AB05 NANOFIB G Fenofibrate - 145mg 145mg Tablet, film coated 1,371,615 L.L
D10BA01 CURACNE G Isotretinoin - 5mg 5mg Capsule, soft 856,028 L.L
J01MA12 VOLCIDIN G Levofloxacin (hemihydrate) - 500mg 500mg Tablet 849,820 L.L
L03AX03 SII-ONCO-BCG G Bacillus Calmette- Guerin Strain - 40mg/ml (1-8x10?CFU) 40mg/ml Injectable dry powder 6,987,981 L.L
M01AE01 PROFINAL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 208,296 L.L
N02AA01 ACTISKENAN G Morphine sulfate - 10mg 10mg Capsule, immediate release 310,428 L.L
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