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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
C01BC04 FLECAINIDE ARROW LAB G Flecainide acetate - 100mg 100mg Tablet, scored 588,603 L.L
C08CA05 NIFELAT 30 LA G Nifedipine - 30mg 30mg Tablet, prolonged release 1,007,882 L.L
C09DX01 VIOSTAN AM PLUS 160/10/12.5 G Valsartan - 160mg, Amlodipine - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,196,020 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 90,869 L.L
J01DH02 MEROPENEM LABATEC G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 7,278,513 L.L
J05AF07 TENOFOVIR DISOPROXIL ARROW G Tenofovir disoproxil - 245mg 245mg Tablet, film coated 9,747,613 L.L
L01CE02 IRINOTECAN THYMOORGAN G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable concentrated solution 6,111,796 L.L
M01AB01 INDOMEL G Indometacin - 100mg 100mg Suppository 222,694 L.L
M05BA08 DROMEZON G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 4,577,128 L.L
P01AB01 PHOZOLE G Metronidazole benzoate - 125mg/5ml 125mg/5ml Suspension 207,336 L.L
R05DA20 ALGOMIEL COUGH SYRUP G Dextromethorphan HBr - 5mg, Carbinoxamine maleate - 2mg Syrup 639,925 L.L
B01AC04 ANTIPLEX G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,295,464 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,894 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 100mg 100mg Capsule, extended release 1,154,361 L.L
C08CA05 NIFELAT 60 LA G Nifedipine - 60mg 60mg Tablet, prolonged release 1,290,089 L.L
D05AA ICHTAMMOL OINTMENT G Tars - 10% 10% Ointment 174,060 L.L
G03DA04 DARSTIN G Progesterone - 10mg/g 10mg/g Gel 380,307 L.L
J01DH02 MEROPENEM MEDIS G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF07 TENOFOVIR DISOPROXIL BIOGARAN G Tenofovir disoproxil - 245mg 245mg Tablet, film coated 9,747,613 L.L
L01CE02 IRNOCAM 100 G Irinotecan HCl - 100mg/5ml 100mg/5ml Injectable solution 7,320,947 L.L
M01AB05 TRATUL G Diclofenac Deanol - 90mg 90mg Injectable solution 490,503 L.L
M05BA08 ZOLEDRA G Zoledronic acid - 4mg 4mg Injectable powder for solution 6,368,470 L.L
P01AB01 METROGYL G Metronidazole benzoate - 200mg/5ml 200mg/5ml Powder for suspension 481,788 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 880,217 L.L
B01AC04 APO-CLOPIDOGREL G Clopidogrel (Bisulfate), - 75mg 75mg Tablet 911,125 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
C08CA05 NIFE-PAR G Nifedipine - 5mg/ml 5mg/ml Solution 36,667,942 L.L
C09DX01 VIOSTAN AM PLUS 160/10/25 G Valsartan - 160mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,196,020 L.L
D05AA VASELINE ICHTYOLEE G Ichthyamol - 10% 10% Ointment 103,668 L.L
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