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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
G03DA04 PROLUTEX B Progesterone - 25mg 25mg Injectable solution 5,570,227 L.L
N02BE51 PANADOL COLD & FLU VAPOUR RELEASE + DECONGESTANT B Paracetamol - 600mg, Phenylephrine HCl - 10mg Powder for solution 524,099 L.L
N02BE51 PANADOL EXTRA WITH OPTIZORB B Paracetamol - 500mg, Caffeine - 65mg Tablet, film coated 524,099 L.L
G03DC02 PRIMOLUT NOR B Norethisterone acetate - 5mg 5mg Tablet 296,989 L.L
N02BE51 PANADOL EXTRA WITH OPTIZORB B Paracetamol - 500mg, Caffeine - 65mg Tablet, film coated 252,642 L.L
G03FB01 PROGYLUTON B Norgestrel - 0.5mg (tablet 2), Estradiol valerate - 2mg (tablet 1, tablet 2) Tablet 193,513 L.L
N02BE51 PANADOL MIGRAINE B Paracetamol - 250mg, Acetylsalicylic acid - 250mg, Caffeine - 65mg Caplet 604,729 L.L
N02BE51 PANADOL COLD AND FLU B Paracetamol - 500mg, Pseudoephedrine HCl - 30mg, Chlorpheniramine maleate - 2mg Tablet 278,175 L.L
C01EA01 PROSTIN VR B Alprostadil - 500mcg/ml 500mcg/ml Injectable concentrated solution 19,894,577 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 1,603,204 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 3,205,064 L.L
G03GA30 PERGOVERIS BioHuman Follitropin alfa - 150IU, Lutropin Alfa - 75IU Injectable powder for solution+diluent 6,523,011 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 5g/50ml 10% Injectable solution 44,463,925 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
L01FX14 POLIVY BioHuman Polatuzumab vedotin - 140mg 140mg Injectable powder for concentrate for solution 1,146,496,418 L.L
L01FX14 POLIVY BioHuman Polatuzumab vedotin - 140mg 140mg Injectable powder for concentrate for solution L.L
G03GA06 PUREGON BioHuman Follitropin beta - 300IU/0.36ml 300IU/0.36ml Injectable solution 12,929,605 L.L
G03GA06 PUREGON BioHuman Follitropin beta - 300IU/0.36ml 300IU/0.36ml Injectable solution 12,929,605 L.L
G03GA06 PUREGON BioHuman Follitropin beta - 600IU/0.72ml 600IU/0.72ml Injectable solution 24,121,923 L.L
G03GA06 PUREGON BioHuman Follitropin beta - 600IU/0.72ml 600IU/0.72ml Injectable solution 24,121,923 L.L
L01XY02 PHESGO BioTech Pertuzumab - 600mg, Trastuzumab - 600mg Injectable solution 326,054,156 L.L
L01XY02 PHESGO BioTech Pertuzumab - 1200mg, Trastuzumab - 600mg Injectable solution 591,417,874 L.L
M05BX04 PROLIA BioTech Denosumab - 60mg/ml 60mg/ml Injectable solution 21,603,638 L.L
R05CB13 PULMOZYME BioTech Dornase alfa (desoxyribonuclease) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution 54,658,804 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 637,365 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 2,126,343 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable solution 883,480 L.L
A10AB04 PROLOG BioTech Insulin lispro - 100U/ml 100U/ml Injectable suspension 1,503,312 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 135mcg/0.5ml 135mcg/0.5ml Injectable solution 15,796,329 L.L
L03AB11 PEGASYS BioTech Peginterferon alfa-2a - 180mcg/0.5ml 180mcg/0.5ml Injectable solution 18,197,019 L.L
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