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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
L01XX02 ERWINASE BioTech Erwinia L-asparaginase - 10,000IU 10,000IU Injectable lyophilised powder for solution 444,434,845 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
L01XX05 CUREAML G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 1,228,272 L.L
L01XX05 CYTODROX G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 3,301,821 L.L
L01XX05 UNIDREA G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule, hard 2,539,862 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution 172,758,585 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution L.L
L01XX35 ANAGRELIDE BIOGARAN G Anagrelide - 0.5mg 0.5mg Capsule 15,754,068 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution 38,083,434 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 200mg/8ml 200mg/8ml Injectable concentrate for solution 63,807,499 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 200mg/8ml 200mg/8ml Injectable concentrate for solution 63,807,499 L.L
L01XX52 VENCLEXTA B Venetoclax - 10mg 10mg Tablet 12,966,030 L.L
L01XX52 VENCLEXTA B Venetoclax - 50mg 50mg Tablet 31,367,183 L.L
L01XX52 VENCLEXTA B Venetoclax - 100mg 100mg Tablet 707,858,935 L.L
L01XX52 VENCLEXTA B Venetoclax - 10mg week 1, Venetoclax - 50mg week 2, Venetoclax - 100mg week 3&4 Tablet 190,943,809 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
L02AE03 ZOLADEX LA B Goserelin (acetate) - 10.8mg 10.8mg Injectable suspension L.L
L02AE03 ZOLADEX DEPOT B Goserelin (acetate) - 3.6mg 3.6mg Injectable suspension 8,820,074 L.L
L02AE03 ZOLADEX LA B Goserelin (acetate) - 10.8mg 10.8mg Injectable suspension 35,121,328 L.L
L02AE04 DECAPEPTYL B Triptorelin - 0.1mg 0.1mg Injectable lyophilised powder for solution+diluent 2,366,507 L.L
L02AE04 DECAPEPTYL LP B Triptorelin (pamoate) - 3mg 3mg Injectable powder for suspension+diluent 11,778,312 L.L
L02AE04 DECAPEPTYL LP B Triptorelin (pamoate) - 11.25mg 11.25mg Injectable powder for suspension+diluent 31,761,098 L.L
L02AE04 GONAPEPTYL B Triptorelin acetate - 0.1mg 0.1mg Injectable solution 4,637,600 L.L
L02AE04 GONAPEPTYL CR B Triptorelin - 3.75mg 3.75mg Injectable powder for suspension+diluent 12,095,730 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
L02BA01 TAMOXIFEN SANDOZ G Tamoxifen (citrate) - 20mg 20mg Tablet, film coated 497,222 L.L
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