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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
L03AX16 MOZOBIL B Plerixafor - 20mg/ml 20mg/ml Injectable solution 413,801,327 L.L
N02AA05 OXYNORM B Oxycodone HCl - 5mg 5mg Capsule, hard 1,991,575 L.L
R01AC03 ALLERGODIL NASAL B Azelastine HCl - 0.14mg/dose 0.14mg/dose Spray, solution 657,139 L.L
C09DA01 HYZAAR B Losartan potassium - 50mg, Hydrochlorothiazide - 12.5mg Tablet 1,523,022 L.L
G04CA04 SILOSIN B Silodosine - 8mg 8mg Capsule 1,927,454 L.L
J07CA02 TETRAXIM (Vaccin Diphterique, tetanique, coquelucheux acellulaire et Poliomyelitique inactivé adsorbé) B Diphteria toxoid purified - ?30IU, Tetanus toxoid purified - ?40IU, Poliomyelitis virus type 1 inactivated - 40D.U., Poliomyelitis virus type 2 inactivated - 8D.U., Poliomyelitis virus type 3 inactivated - 32D.U., Bordetella Pertussis Antigens: toxoid - 25mcg, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg Injectable suspension 1,628,737 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg 10mg Capsule, hard 3,988,525 L.L
N06AB04 CIPRAM B Citalopram - 20mg 20mg Tablet 2,280,501 L.L
R01AD08 OTRIALLERGY B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Spray, suspension 675,953 L.L
A02BC05 NEXIUM B Esomeprazole sodium - 40mg 40mg Injectable powder for solution 5,254,424 L.L
C07AB02 BETALOC ZOK B Metoprolol succinate - 50mg 50mg Tablet, controlled release 491,846 L.L
J07CA06 INFANRIX IPV + HIB B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen(Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg+pertactin 8mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 3,014,239 L.L
L01EJ01 JAKAVI B Ruxolitinib - 20mg 20mg Tablet 341,075,567 L.L
N02AA05 OXYNORM B Oxycodone HCl - 20mg 20mg Capsule, hard 7,634,958 L.L
R06AE09 XYZAL B Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 572,477 L.L
J07CA06 PENTAXIM B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen (Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 2,558,676 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 545,600 L.L
C07AB02 BETALOC ZOK B Metoprolol succinate - 25mg 25mg Tablet, controlled release 219,046 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 1,087,169 L.L
J07CA09 INFANRIX HEXA B Diphteria toxoid purified (Prefilled syringe) - ?30IU/0.5ml, Tetanus toxoid purified (prefilled syringe) - ?40IU/0.5ml, Bordetella pertussis antigen (Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg+pertactin 8mcg/0.5ml, Poliomyelitis virus type 1 antigen (prefilled syringe) - 40D.U./0.5ml, Poliomyelitis virus type 2 antigen(prefilled syringe) - 8D.U./0.5ml, Poliomyelitis virus type 3 antigen (prefilled syringe) - 32D.U./0.5ml, HBs Antigen (prefilled syringe) - 10mcg/0.5ml, H. Influenza type b polysaccharide (Vial) - 10mcg/0.5ml Injectable suspension 4,230,416 L.L
L01EK01 INLYTA B Axitinib - 5mg 5mg Tablet, film coated 184,486,511 L.L
L04AA06 MYFORTIC B Mycophenolic acid (sodium) - 360mg 360mg Tablet, gastroresistant 20,324,991 L.L
M01AE01 ALGIFAST 400 B Ibuprofen Lysine - 400mg 400mg Powder for suspension 473,033 L.L
N06AB05 SEROXAT B Paroxetine (HCl) - 20mg 20mg Tablet, film coated 1,586,205 L.L
R01AD09 NASONEX B Mometasone furoate (monohydrate) - 50mcg/dose 0.05% Spray, suspension 529,474 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 287,582 L.L
B03BA51 DEPOVEX B Aluminium monostearate - 20mg/ml, Cyanocobalamine - 1mg/ml Injectable oily suspension 423,310 L.L
C10AB05 LIPANTHYL 200 M B Fenofibrate - 200mg 200mg Capsule 1,115,364 L.L
J01MA14 AVALOX B Moxifloxacin (HCl) - 400mg 400mg Tablet, film coated 1,521,230 L.L
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