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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
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated L.L
L01EA04 BOSULIF B Bosutinib - 400mg 400mg Tablet, film coated L.L
L01EA04 BOSULIF B Bosutinib - 500mg 500mg Tablet, film coated L.L
L01EA04 BOSULIF B Bosutinib - 100mg 100mg Tablet, film coated 35,663,747 L.L
L01EA04 BOSULIF B Bosutinib - 400mg 400mg Tablet, film coated 123,564,667 L.L
L01EA04 BOSULIF B Bosutinib - 500mg 500mg Tablet, film coated 154,453,246 L.L
M03AX01 BOTOX BioTech Clostridium botulinum type A neurotoxin complex - 100U 100U Injectable powder for solution 18,625,995 L.L
M03AX01 BOTOX BioTech Clostridium botulinum type A neurotoxin complex - 100U 100U Injectable powder for solution 18,625,995 L.L
C01EB17 BRAVIGO G Ivabradine (HCl) - 5mg 5mg Tablet, film coated 1,237,679 L.L
C01EB17 BRAVIGO G Ivabradine (HCl) - 7.5mg 7.5mg Tablet, film coated 1,237,679 L.L
M01AC01 BREXIN B Piroxicam-?-cyclodextrin - 20mg 20mg Tablet, scored 971,598 L.L
R03AL11 BREZTRI AEROSPHERE B Formoterol fumarate dihydrate - 5mcg, Glycopyrronium Bromide - 7.2mcg, Budesonide - 160mcg Inhalation suspension 6,705,774 L.L
V03AB35 BRIDION B Sugammadex - 100mg/ml 100mg/ml Injectable solution 54,230,830 L.L
B01AC24 BRILINTA B Ticagrelor - 90mg 90mg Tablet, film coated 5,544,694 L.L
S01EA05 BRIMO G Brimonidine tartrate - 0.2% 0.2% Drops solution 658,483 L.L
S01EA05 BRIMOGAN G Brimonidine tartrate - 0.2% w/v 0.2% w/v Drops solution 483,783 L.L
S01EA05 BRIMONIDINE BIOGARAN G Brimonidine tartrate - 2mg/ml 0.2% Drops solution 412,560 L.L
C01BG11 BRINAVESS B Vernakalant - 20mg/ml 20mg/ml Injectable concentrate for solution 41,821,582 L.L
N06AX26 BRINTELLIX B Vortioxetine - 5mg 5mg Tablet, film coated 2,592,272 L.L
N06AX26 BRINTELLIX B Vortioxetine - 10mg 10mg Tablet, film coated 4,345,987 L.L
N06AX26 BRINTELLIX B Vortioxetine - 20mg 20mg Tablet, film coated 6,927,508 L.L
N03AX23 BRIVIACT B Brivaracetam - 25mg 25mg Tablet, film coated 9,627,931 L.L
N03AX23 BRIVIACT B Brivaracetam - 50mg 50mg Tablet, film coated 9,627,931 L.L
N03AX23 BRIVIACT B Brivaracetam - 10mg/ml 10mg/ml Solution 10,314,804 L.L
N05BA08 BROMAZEPAM BIOGARAN G Bromazepam - 6mg 6mg Tablet, scored 180,075 L.L
R05X BROMEX G Pyrilamine Maleate (Mepyramine) - 12.5mg/5ml, Bromhexine HCl - 4mg/5ml Elixir 250,851 L.L
R05CB02 BROMHEXINE G Bromhexine - 4mg/5ml 4mg/5ml Elixir 176,619 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
R05FB BRONCHOPHANE G Dextrometorphan HBr - 4.58mg/5ml, Diphenydramine HCl - 5mg/5ml, Ephedrine HCl - 7.5mg/5ml, Guaifenesin - 50mg/5ml Syrup 115,570 L.L
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