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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
C05AX HEMOCARE G Bismuth subgallate - 100mg, Zinc oxide - 100mg, Lidocaine - 60mg Suppository 588,731 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 600IU, Blood Coagulation Factor VIII - 250IU Injectable lyophilised powder for solution+diluent 14,117,737 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 2400IU, Blood Coagulation Factor VIII - 1000IU Injectable lyophilised powder for solution+diluent 49,643,758 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent 33,698,319 L.L
N02BE51 HUMACE PLUS G Paracetamol - 500mg, Aceclofenac (potassium) - 200mg Tablet 575,165 L.L
N02BE51 HUMEXLIB PARACETAMOL CHLORPHENAMINE B Paracetamol - 500mg, Chlorphenamine maleate - 4mg Capsule 598,010 L.L
C09DA01 HYZAAR B Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet 1,523,022 L.L
N02BE51 HUMEX RHUME B Pseudoephedrine HCl (tablet) - 60mg, Paracetamol (tablet) - 500mg, Paracetamol (capsule) - 500mg, Chlorphenamine maleate (capsule) - 4mg Tablet, capsule 467,657 L.L
C09DA01 HYZAAR B Losartan potassium - 100mg, Hydrochlorothiazide - 12.5mg Tablet 1,740,596 L.L
R05CA12 HEDECTON COUGH G Ivy leaf soft extract - 40mg/5ml Syrup 467,657 L.L
A03AX HEPABYL G Sorbitol - 2.5g/5ml, Diisopromine - 0.02g/5ml Liquid 238,052 L.L
R06AA52 HISTALIX G Diphenhydramine HCl - 14mg/5ml, Ammonium chloride - 135mg/5ml, Menthol - 1.1mg/5ml Syrup 405,840 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine - 2mg/5ml, Dexamethasone - 0.25mg/5ml Syrup 712,876 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine maleate - 2mg, Dexamethasone - 0.25mg, Fluphenazine HCl - 0.25mg Tablet, coated 579,772 L.L
D06BA51 HYALO4 PLUS G Hyaluronic acid (sodium) - 0.2%, Silver sulfadiazine - 1% Cream 466,313 L.L
B05BB02 HI-SODIUM WITHOUT POTASSIUM INJECTION G Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 166,708 L.L
B05BB02 HI-SODIUM INJECTION G Sodium lactate - 0.223g%, Sodium dihydrogenophosphate - 0.137g%, Potassium chloride - 0.149g%, Sodium chloride - 0.175g%, Dextrose, H2O - 5.0g% Injectable solution 176,024 L.L
B05BB02 HI-SODIUM INJECTION WITH POTASSIUM G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
D07CA01 HYDROMYCINE G Neomycin sulfate - 0.005g/g, Hydrocortisone acetate - 0.01g/g Cream 238,052 L.L
B02BD06 HAEMATE P BioHuman Von Willebrand Factor - 1200IU, Blood Coagulation Factor VIII - 500IU Injectable lyophilised powder for solution+diluent L.L
A06AA01 HUILE DE PARAFFINE G Liquid paraffin - Liquid 207,336 L.L
A06AB05 HUILE DE RICIN G Castor oil - Liquid 163,821 L.L
J07CA09 HEXAXIM BioTech Diphteria Toxoid - ?20IU/0.5ml, Tetanus toxoid - ?40IU/0.5ml, Bordetella Pertussis Antigens: toxoid - 25mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg/0.5ml, Polio virus inactivated type 1 (Mahoney strain) - 40D antigen units/0.5ml, Polio virus inactivated type 2 (MEF-I strain) - 8D antigen units/0.5ml, Polio virus inactivated type 3 (Saukett strain) - 32D antigen units/0.5ml, Hepatitis B, surface antigen - 10mcg/0.5ml, H. Influenza type b polysaccharide1 ,2 - 12mcg/0.5ml, 1 conjugated to tetanus protein - 22-36mcg, 2 adsorbed on aluminium hydroxide hydrated, Al+++ - 0.6mg Injectable suspension 4,462,901 L.L
D03AX HEALIN B G ?-sitosterol - 0.25% 0.25% Ointment 849,820 L.L
A11CC06 HIDROFEROL G Calcifediol - 0.266mg 0.266mg Capsule, soft 1,316,966 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
J05AF10 HEPCAVIR 0.5 G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 18,998,515 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 0.5ml/dose 0.5ml/dose Injectable suspension 1,777,904 L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 1ml/dose 0.5ml/dose Injectable suspension 2,257,655 L.L
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