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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
J01DI54 ZERBAXA B Ceftolozane Sulfate - 1g, Tazobactam (sodium) - 0.5g Injectable powder for concentrate for solution 74,780,802 L.L
J07BX05 ABRYSVO B RSV subgroup A stabilized perfusion F antigen 60mcg - 60mcg, RSV subgroup B stabilized perfusion F antigen 60mcg - 60mcg, Glycoprotein F stabilized in the perfusion conformation - Injectable powder + solvent 22,650,721 L.L
J01DD04 MEGION-A G Ceftriaxone - 0.5g/2ml, Lidocaine (ampoule) - 0.5g/2ml Injectable powder + solvent 342,285 L.L
L04AC02 SIMULECT BioTech Basiliximab - 20mg 20mg Injectable powder + solvent 131,822,828 L.L
J01DD04 MEGION-A G Ceftriaxone - 1g/3.5ml, Lidocaine (ampoule) - 1g/3.5ml Injectable powder + solvent 599,719 L.L
G03GA02 MERIONAL HG BioHuman Menotropin - 75IU 75IU Injectable powder + solvent 24,771,315 L.L
G03GA02 MERIONAL HG BioHuman Menotropin - 150IU 150IU Injectable powder + solvent 41,777,992 L.L
G03GA02 MERIONAL HG BioHuman Menotropin - 900IU 900IU Injectable powder + solvent 25,830,983 L.L
L01BA04 PEMETREXED NEAPOLIS G Pemetrexed (disodium) - 500mg Injectable powder L.L
J01DB04 CEFAZOL IM/IV G Cefazolin (sodium) - 1g 1g Injectable powder 5,375,370 L.L
L01BA04 PEMETREXED NEAPOLIS G Pemetrexed (disodium) - 500mg Injectable powder 41,289,202 L.L
J01DD04 CEFAXONE G Ceftriaxone - 1g 1g Injectable powder 403,153 L.L
L01BC07 AZACITIDINE SPC G Azacitidine - 100mg 100mg Injectable powder 10,706,993 L.L
L01FX02 MYLOTARG BioTech Gemtuzumab Ozogamicin - 4.5mg 4.5mg Injectable powder 748,160,090 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
J01DH03 ERTANZ G Ertapenem - 1g 1g Injectable powder 2,521,049 L.L
J01DH51 SYNERGIC G Imipenem - 500mg, Cilastatin - 500mg Injectable powder 1,142,266 L.L
N01AH06 REMIFENTANIL MEDIS G Remifentanil (HCl) - 1mg 1mg Injectable powder 1,101,951 L.L
N01AH06 REMIFENTANIL MEDIS G Remifentanil (HCl) - 5mg 5mg Injectable powder 2,576,146 L.L
J01CR02 VAAMOX IV G Amoxicillin - 1g, Clavulanic Acid - 200mg Injectable powder 225,766 L.L
J01CR02 VAAMOX IV G Amoxicillin - 1g, Clavulanic Acid - 200mg Injectable powder 2,150,148 L.L
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L01FX07 BLINCYTO BioTech Blinatumomab - 35mcg 35mcg Injectable lyophilised powder for solution+stabilizer 239,484,334 L.L
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J07AH08 NIMENRIX B Polysaccharide of Neisseria meningitidis (serogroups A, C, Y and W-135) conjugated - 5mcg/0.5ml, Tetanus toxoid carrier protein - 44mcg/0.5ml Injectable lyophilised powder for solution+diluent 4,483,059 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,561,486 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,247,110 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 27,354,631 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 26,495,478 L.L
B02BD02 BERIATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 47,481,122 L.L
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