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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
L02BX02 FIRMAGON B Degarelix (acetate) - 120mg 120mg Injectable powder for solution+diluent 24,325,802 L.L
R06AX CYPRO-BC B Cyproheptadine HCl - 2mg/5ml, Vitamin B3 - 5mg/5ml, Vitamin B6 - 0.60mg/5ml, Vitamin B2 - 0.75mg/5ml, Vitamin B1 - 0.60mg/5ml, Vitamin C - 20mg/5ml Syrup 449,227 L.L
A10BD11 JENTADUETO B Metformin - 1000mg, Linagliptin - 2.5mg Tablet, film coated 3,542,369 L.L
B01AC27 UPTRAVI B Selexipag - 400mcg 400mcg Tablet, film coated 275,097,581 L.L
C01EA01 PROSTIN VR B Alprostadil - 500mcg/ml 500mcg/ml Injectable concentrated solution 19,894,577 L.L
D07AB02 LOCOID CRELO 0.1% B Hydrocortisone butyrate - 1mg/g 0.1% Emulsion 177,387 L.L
N02AB03 DUROGESIC B Fentanyl - 16.8mg 100mcg/h Patch 5,911,563 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
R06AX02 PERIACTIN B Cyproheptadine HCl - 4mg 4mg Tablet 255,970 L.L
B01AC27 UPTRAVI B Selexipag - 600mcg 600mcg Tablet, film coated 275,097,581 L.L
D07AB02 LOCOID B Hydrocortisone butyrate - 0.1% 0.1% Lotion 201,576 L.L
J01CR02 AUGMENTIN B Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 524,099 L.L
J01FF01 DALACIN-C B Clindamycin HCl - 150mg 150mg Capsule 287,582 L.L
N02AB03 DUROGESIC B Fentanyl - 8.4mg 50mcg/h Patch 3,019,614 L.L
R01AD11 NASACORT AQ B Triamcinolone acetonide - 55mcg/dose 55mcg/dose Spray, suspension 1,003,850 L.L
R06AX13 CLARITINE B Loratadine (micronised) - 10mg 10mg Tablet 219,046 L.L
A04AA05 ALOXI B Palonosetron HCl - 0.25mg/5ml 0.25mg/5ml Injectable solution 3,656,595 L.L
A10BD11 JENTADUETO B Metformin - 850mg, Linagliptin - 2.5mg Tablet, film coated 3,542,369 L.L
B01AC27 UPTRAVI B Selexipag - 800mcg 800mcg Tablet, film coated 275,097,581 L.L
C01EB15 VASTAREL B Trimetazidine - 35mg 35mg Tablet, film coated, modified release 1,053,573 L.L
C09AA05 TRITACE B Ramipril - 10mg 10mg Tablet 689,391 L.L
D07AB02 LOCOID B Hydrocortisone butyrate - 0.1% 0.1% Lotion 201,576 L.L
G04BD08 VESICARE B Solifenacin succinate - 10mg 10mg Tablet, film coated 1,619,330 L.L
J01FF01 DALACIN-C B Clindamycin HCl - 300mg 300mg Capsule 478,408 L.L
N02AB03 DUROGESIC B Fentanyl - 4.2mg 25mcg/h Patch 1,509,135 L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 12.5mg 12.5mg Tablet, controlled release 2,371,608 L.L
R06AX13 CLARITINE B Loratadine (micronised) - 10mg 10mg Tablet 618,168 L.L
B01AC27 UPTRAVI B Selexipag - 1000mcg 1000mcg Tablet, film coated 275,097,581 L.L
D07AC01 BETNOVATE B Betamethasone - 0.1% 0.1% Solution 235,172 L.L
N02AB03 PECFENT B Fentanyl (citrate) - 400mcg/spray 400mcg/spray Spray 5,718,050 L.L
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