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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
L01FX13 PADCEV 30mg Injectable powder for concentrate for solution L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
G04CA01 PROSTETROL G Alfuzosin HCl - 10mg 10mg Tablet, modified release 360,150 L.L
G04CA01 PROSTETROL G Alfuzosin HCl - 10mg 10mg Tablet, modified release 682,672 L.L
L01EM03 PIQRAY B Alpelisib - 150mg 150mg Tablet, film coated 359,195,954 L.L
L01EM03 PIQRAY B Alpelisib - 200mg, Alpelisib - 50mg 150mg Tablet, film coated 359,195,954 L.L
N05BA12 PAZOLAM G Alprazolam - 0.5mg 0.5mg Tablet 563,070 L.L
C01EA01 PROSTIN VR B Alprostadil - 500mcg/ml 500mcg/ml Injectable concentrated solution 19,894,577 L.L
N04BB01 PK-MERZ B Amantadine (sulfate) - 100mg 100mg Tablet, film coated 1,382,814 L.L
C09DB01 POVAM G Amlodipine (besylate) - 10mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
C09DB01 POVAM G Amlodipine (besylate) - 5mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
J01CR02 POSMOX G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Powder 616,824 L.L
A13A POTENCIATOR G Arginine Aspartate - 5g/10ml 5g Solution 1,402,972 L.L
N05AX12 PIRIFY G Aripiprazole - 10mg 10mg Tablet 795,555 L.L
N05AX12 PIRIFY G Aripiprazole - 15mg 15mg Tablet 795,555 L.L
N05AX12 PIRIFY G Aripiprazole - 5mg 5mg Tablet 614,328 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 18mg 18mg Capsule 3,744,073 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 25mg 25mg Capsule 4,121,565 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 40mg 40mg Capsule 4,706,136 L.L
N06BA09 PMS-ATOMOXETINE G Atomoxetine (HCl) - 60mg 60mg Capsule 5,228,891 L.L
R05C PULMONAL SIROP G Belladona tincture - 0.5g/5ml, Drosera tincture - 2g/5ml, Ammonium bromide - 2g/5ml, Sodium benzoate - 2g/5ml Syrup 148,463 L.L
J01CE01 PENICILLINE G PANPHARMA G Benzylpenicillin (sodium) - 1,000,000IU 1,000,000IU Injectable powder for solution 2,858,353 L.L
A02BD08 PYLERA B Bismuth subcitrate potassium - 140mg, Tetracycline HCl - 125mg, Metronidazole - 125mg Capsule 6,156,142 L.L
C02KX01 PMS-BOSENTAN G Bosentan (monohydrate) - 125mg 125mg Tablet 77,539,821 L.L
C02KX01 PMS-BOSENTAN G Bosentan (monohydrate) - 62.5mg 62.5mg Tablet 77,539,821 L.L
R03BA02 PULMICORT B Budesonide - 0.5mg/ml 0.5mg/ml Inhalation suspension for nebuliser 2,015,764 L.L
G02CB03 PROCTIN G Cabergoline - 0.5mg 0.5mg Tablet 350,679 L.L
G02CB03 PROCTIN G Cabergoline - 0.5mg 0.5mg Tablet 1,300,328 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 473,545 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 1,689,402 L.L
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