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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
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
B01AC04 CLOPIDOGREL ARROW G Clopidogrel besylate - 75mg 75mg Tablet, film coated 658,483 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 217,210 L.L
C01CA04 DOPAMINE RENAUDIN G Dopamine HCl - 200mg/5ml 4% Injectable concentrated solution 1,107,326 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 1g 1g Injectable powder for solution 2,857,009 L.L
J01FA09 ERACID 500 G Clarithromycin - 500mg 500mg Tablet, film coated 628,918 L.L
J05AR10 KALUVIA G Lopinavir - 200mg, Ritonavir - 50mg Tablet, film coated 7,632,790 L.L
L02BB03 PROSMIDE G Bicalutamide - 50mg 50mg Tablet, film coated 3,597,914 L.L
M01AB16 ACECLOFAR G Aceclofenac - 100mg 100mg Tablet 131,697 L.L
N01BB02 LIDOCAINE PANPHARMA 2% G Lidocaine (HCl) - 20mg/ml 2% Injectable solution 3,398,578 L.L
N03AX14 LEVETIRACETAM ARROW LAB G Levetiracetam - 1000mg 1000mg Tablet, film coated, breakable 2,940,327 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 9,340,433 L.L
P03AX01 SPIDOGALE G Benzyl benzoate - 10g/100ml, Sulfur colloïdal - 5g/100ml Lotion 207,336 L.L
R06AD52 CODOPALM G Promethazine HCl - 5mg/5ml, Sodium gentisate - 0.5mg/5ml Syrup 149,742 L.L
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 4,365,735 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,964,517 L.L
B01AC04 CLOPIKEY G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 748,520 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 240,255 L.L
C01CA06 PHENYLEPHRINE HYDROCHLORIDE G Phenylephrine HCl - 10mg/ml 1% Injectable solution 10,282,281 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
J01CA04 AMOXICILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 6,199,145 L.L
J01FA09 KLERIMED G Clarithromycin - 500mg 500mg Tablet 686,704 L.L
J05AR12 TELADINE G Lamivudine - 300mg, Tenofovir disoproxil fumarate - 300mg Tablet 17,454,739 L.L
L01EA02 APO-DASATINIB G Dasatinib - 70mg 70mg Tablet 71,323,688 L.L
M01AB16 ARACENAC G Aceclofenac - 100mg 100mg Tablet, film coated 330,585 L.L
N01BB02 LIDO-CARE G Lidocaine - 2% 2% Injectable solution 100,788 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 1000mg 1000mg Tablet, coated, scored 3,191,626 L.L
N05CM18 PROXIDA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 1,771,184 L.L
R01AA05 UTABON G Oxymetazoline HCl - 0.5mg/ml 0.5mg/ml Spray, solution 302,365 L.L
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