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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 MESPORIN-1000 IM G Ceftriaxone (sodium) - 1g 1,000mg Injectable powder for solution+diluent 417,935 L.L
J01DD04 MESPORIN-1000 IV G Ceftriaxone (sodium) - 1g 1,000mg Injectable powder for solution+diluent 417,935 L.L
J01DD04 AXONE 500MG IM G Ceftriaxone (sodium) - 500mg 500mg Injectable powder for solution+diluent 393,746 L.L
H02AB04 SOLU MEDROL Act-O-Vial B Methylprednisolone sodium succinate - 40mg 40mg Injectable powder for solution+diluent 313,115 L.L
H02AB04 LISAMETHYLE G Methylprednisolone sodium succinate - 40mg/2ml 40mg/2ml Injectable powder for solution+diluent 7,905,545 L.L
H04AA01 GLUCAGEN BioTech Glucagon HCl - 1mg 1mg Injectable powder for solution+diluent 1,343,444 L.L
G03GA02 MENOPUR BioHuman Menotropin - 1,200IU 1,200IU Injectable powder for solution+diluent 27,815,659 L.L
G03GA02 MENOPUR BioHuman Menotropin - 600IU 600IU Injectable powder for solution+diluent 13,907,829 L.L
G03GA30 PERGOVERIS BioHuman Follitropin alfa - 150IU, Lutropin Alfa - 75IU Injectable powder for solution+diluent 6,523,011 L.L
B01AD11 METALYSE BioTech Tenecteplase - 10,000IU 10,000IU Injectable powder for solution+diluent 74,851,424 L.L
B02BB01 FIBRYGA BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution+solvent 39,357,009 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 500IU 500U (50U/ml) Injectable powder for solution+solvent 38,938,709 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 1000IU 1000U (50U/ml) Injectable powder for solution+solvent 76,827,220 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 500IU 500IU Injectable powder for solution+solvent 76,080,435 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 1000IU 1000IU Injectable powder for solution+solvent 143,279,414 L.L
B02BD04 REFIXIA BioTech Nonacog beta pegol (factor IX) - 2000IU 2000IU Injectable powder for solution+solvent 286,711,575 L.L
L01FD01 TRAZIMERA BioTech Trastuzumab - 440mg 440mg Injectable powder for solution+solvent 75,295,202 L.L
S01EB09 MIOVISIN G Acetylcholine chloride - 20mg/2ml 20mg/2ml Injectable powder for solution+solvent 6,449,100 L.L
J01XB01 COLISTIMETHATE SODIQUE PANPHARMA G Colistimethate Sodium - 1.000.000IU 1.000.000IU Injectable powder for solution, Inhalation powder 6,392,659 L.L
J01XB01 COLISTIN HIKMA G Colistimethate Sodium - 1MIU 1MIU Injectable powder for solution, Inhalation powder 903,062 L.L
J01XB01 COLIXIN G Colistimethate Sodium - 1,000,000IU 1,000,000IU Injectable powder for solution, Inhalation powder 20,296,042 L.L
L01FB01 BESPONSA FOR INJECTION BioTech Inotuzumab Ozogamicin - 0.9mg 0.9mg Injectable powder for suspension 921,176,511 L.L
L01BC07 AZACITIDINE EVER PHARMA G Azacitidine - 100mg/100ml 25mg/ml Injectable powder for suspension 10,967,854 L.L
L01BC07 VAPREZA 100 G Azacitidine - 100mg 100mg Injectable powder for suspension 10,706,993 L.L
L03AX03 BCG-MEDAC G BCG seed RIVM derived from seed 1173-P2 - 2x10? to 3x10? viable units Injectable powder for suspension+diluent 13,873,850 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
J07BK01 VARIVAX B Varicella virus, live attenuated - 1350PFU Injectable powder for suspension+diluent 4,102,751 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent 36,504,302 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent 54,757,132 L.L
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