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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
N02BE01 PARACETAMOL PANPHARMA G Paracetamol - 1000mg/100ml 10mg/ml Injectable solution 2,215,996 L.L
N05AH03 OLIZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,466,580 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 40mg 40mg Capsule 4,706,136 L.L
S01CA01 OPTIDEX T G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 266,081 L.L
L01EF01 PALBRANCE 125 G Palbociclib - 125mg 125mg Capsule L.L
A02BC05 METAPRO G Esomeprazole - 40mg 40mg Tablet, gastroresistant 639,669 L.L
A11CC06 HIDROFEROL G Calcifediol - 0.266mg 0.266mg Capsule, soft 1,316,966 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 209,151 L.L
C07AB03 ATENOLOL BIOGARAN G Atenolol - 50mg 50mg Tablet, scored 295,645 L.L
C10AB05 LIPAFIB G Fenofibrate - 160mg 160mg Tablet 627,127 L.L
D11AX01 MINOXIDIL BAILLEUL G Minoxidil - 2% 2% Solution 2,839,539 L.L
J01DD04 CEFAXONE IV G Ceftriaxone - 1g 1g Injectable lyophilised powder for solution+diluent 403,153 L.L
J01XB01 COLISTIN HIKMA G Colistimethate Sodium - 1MIU 1MIU Injectable powder for solution, Inhalation powder 903,062 L.L
M02AA15 CLOFEN G Diclofenac sodium (diethylamine) - 10mg/g 1% Creamagel 210,983 L.L
N02BE01 PARAMED G Paracetamol - 10mg/ml 10mg/ml Injectable solution 814,369 L.L
N05AH03 PRANZA G Olanzapine - 5mg 5mg Tablet, orodispersible 1,773,872 L.L
N06BA09 APO-ATOMOXETINE G Atomoxetine (HCl) - 25mg 25mg Capsule 3,703,630 L.L
R03BB01 IPRAVENT G Ipratropium bromide - 20mcg/2ml 20mcg/2ml Inhalation solution 630,262 L.L
A02BC05 PRIMAZOL 40 G Esomeprazole (magnesium dihydrate) - 40mg 40mg Capsule, gastro-resistant 639,925 L.L
A11CC06 DEDROGYL G Calcifediol - 15mg/100ml 15mg/100ml Drops solution 827,807 L.L
B03BB01 ACFOL G Folic acid - 5mg 5mg Tablet 355,798 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 222,941 L.L
C07AB03 ATONIUM G Atenolol - 50mg 50mg Tablet 239,588 L.L
C09DA03 VIOSTAN PLUS 80/12.5 G Valsartan - 80mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 547,520 L.L
C10AB05 FINACOR G Fenofibrate micronised - 160mg 160mg Capsule 774,309 L.L
D11AX01 ALOPEXY G Minoxidil - 50mg/ml 5% Solution 896,343 L.L
J01DD04 CEFTRIAXONE PANPHARMA G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 8,005,714 L.L
J01XB01 COLISTIN/NORMA G Colistimethate Sodium - 1MIU 1MIU Injectable solution 872,154 L.L
L01BA04 PEMETREXED EVER PHARMA G Pemetrexed (disodium) - 100mg/4ml 100mg/4ml Injectable concentrate for solution 12,185,492 L.L
M02AA15 DICLOGESIC G Diclofenac sodium (diethylamine) - 10mg/g 1% Gel 135,728 L.L
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