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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
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 2,032,899 L.L
A02BC05 ESAC G Esomeprazole sodium - 40mg 40mg Injectable powder for solution 430,030 L.L
A11CC06 DEDROGYL G Calcifediol - 15mg/100ml 15mg/100ml Drops solution 827,807 L.L
B03BA01 JECTIN-12 G Cyanocobalamin - 1000mcg/1ml 1000mcg/1ml Injectable solution 567,102 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 688,359 L.L
C07AB02 B-BLOK SDK G Metoprolol succinate - 50mg 50mg Tablet, controlled release 295,645 L.L
C09DA01 LOSARTAN/HYDROCHLOROTHIAZIDE ARROW LAB G Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 470,345 L.L
C10AB05 LIPAFIB G Fenofibrate - 160mg 160mg Tablet 627,127 L.L
D10BA01 CURACNE G Isotretinoin - 40mg 40mg Capsule, soft gelatin 3,553,120 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 8mg 8mg Capsule 555,007 L.L
J01DD01 CEFOTAX G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 217,702 L.L
J01MA12 TAVAQUIN G Levofloxacin (hemihydrate) - 750mg 750mg Tablet, film coated 1,389,533 L.L
L01EJ01 CELEZON G Ruxolitinib - 20mg 20mg Tablet 188,515,591 L.L
M01AE01 ? IBUPROFEN G Ibuprofen - 400mg/100ml 400mg/100ml Injectable solution 383,955 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 500mg 500mg Tablet, coated, scored 2,651,401 L.L
N06AB04 LECITAL 40 G Citalopram - 40mg 40mg Caplet 1,761,778 L.L
R01AD08 TICANASE G Fluticasone propionate - 50mcg/actuation 12g/Bottle Spray, suspension 405,840 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 4,365,735 L.L
A02BC05 ESOMEPRAZOLE NORMON G Esomeprazole - 40mg 40mg Injectable powder for solution 430,030 L.L
B03BA05 COBAL G Mecobalamine - 500mcg/ml 500mcg/ml Injectable solution 1,128,828 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 144,797 L.L
C09DA01 LOSARTAN/HYDROCHLOROTHIAZIDE BGR G Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet, coated 439,436 L.L
C10AB05 FINACOR G Fenofibrate micronised - 160mg 160mg Capsule 774,309 L.L
D10BA01 CURACNE G Isotretinoin - 40mg 40mg Capsule, soft gelatin 3,553,120 L.L
G04CA52 DUTAMSUVITAE G Tamsulosin HCl - 0.4mg, Dutasteride - 0.5mg Capsule, hard 2,168,962 L.L
J01DD01 CEFOTAXIME PANPHARMA G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution 6,127,922 L.L
N02AA05 OXYCODONE RENAUDIN G Oxycodone HCl - 10mg/10ml 10mg/10ml Injectable solution 2,432,355 L.L
N03AX14 LEVIPHAR G Levetiracetam - 500mg 500mg Tablet, film coated 1,451,350 L.L
R06AE09 LEVOTREX G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
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