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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
J01DD04 TRAVILAN IM G Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 438,093 L.L
L01AC01 TEPADINA G Thiotepa - 100mg 100mg Injectable powder for concentrate for solution 98,197,306 L.L
L04AA04 THYMOGLOBULINE 5mg/ml BioTech Rabbit anti-human thymocyte immunoglobulin - 25mg/5ml 25mg/5ml Injectable powder for solution 21,092,764 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 150mg 150mg Injectable powder for solution 28,550,630 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 438,093 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution 4,542,188 L.L
N01AF03 THIOPENTAL PANPHARMA G Thiopental - 500mg 500mg Injectable powder for solution 8,446,717 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 53,437,592 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 24,369,850 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 13,394,024 L.L
J01DD04 TRIAXONE G Ceftriaxone (sodium) - 500mg 500mg Injectable powder for solution+diluent 356,118 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 440mg 440mg Injectable powder for solution+solvent 75,295,202 L.L
J07AP03 TYPHIM VI B Salmonella typhi polysaccharides - 0.025mg/0.5ml 0.025mg/0.5ml Injectable solution 1,118,077 L.L
J01MA12 TAVANIC 500MG B Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 1,988,887 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 0.75mg/0.5ml 0.75mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 1.5mg/0.5ml 1.5mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 3mg/0.5ml 3mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 4.5mg 4.5mg/0.5ml Injectable solution 10,165,201 L.L
L04AC13 TALTZ BioTech Ixekizumab - 80mg/ml 80mg/ml Injectable solution 85,080,792 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
L01FF05 TECENTRIQ BioTech Atezolizumab - 1875mg/15ml 1875mg/15ml Injectable solution 375,054,619 L.L
A10AE04 TOUJEO BioTech Insulin glargine - 300Units/ml 300Units/ml Injectable solution 4,559,658 L.L
A10AE06 TRESIBA BioTech Insulin degludec - 100IU/ml 100IU/ml Injectable solution 6,857,628 L.L
A11DB TRILAGAVIT G Vitamin B12 - 1mg/3ml, Vitamin B6 - 100mg/3ml, Vitamin B1 - 100mg/3ml Injectable solution 579,196 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 2,592,272 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 8,282,804 L.L
G03BA03 TESTOVIRON DEPOT B Testosterone Enantate - 250mg/ml 250mg/ml Injectable solution 456,906 L.L
M01AB05 TRATUL G Diclofenac Deanol - 90mg 90mg Injectable solution 490,503 L.L
B06AC05 TAKHZYRO BioTech Lanadelumab - 300mg/2ml Injectable solution 1,204,227,927 L.L
    4
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