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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
A07EA06 BUDENOFALK B Budesonide - 3mg 3mg Capsule 8,554,692 L.L
A10BJ06 OZEMPIC B Semaglutide - 1mg 1mg Injectable solution 10,927,526 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
C03CA02 BURINEX B Bumetanide - 5mg 5mg Tablet 1,054,916 L.L
L01EM03 PIQRAY B Alpelisib - 200mg 200mg Tablet, film coated 359,195,954 L.L
R03AK12 ZEPHIRUS B Salmeterol - 20mcg, Budesonide - 120mcg Capsule, inhalation 1,412,378 L.L
S01AE01 OFLOX B Ofloxacin - 3mg/ml 0.3% Drops solution 366,869 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
C03DA01 ALDACTONE B Spironolactone - 100mg 100mg Tablet 458,250 L.L
J07BM03 GARDASIL 9 HUMAN PAPILLOMAVIRUS 9- VALENT VACCINE RECOMBINANT B Papillomavirus (human type 6) - 30mcg/0.5ml, Papillomavirus (human type 11) - 40mcg/0.5ml, Papillomavirus (human type 16) - 60mcg/0.5ml, Papillomavirus (human type 18) - 40mcg/0.5ml, Papillomavirus (human type 31) - 20mcg/0.5ml, Papillomavirus (human type 33) - 20mcg/0.5ml, Papillomavirus (human type 45) - 20mcg/0.5ml, Papillomavirus (human type 52) - 20mcg/0.5ml, Papillomavirus (human type 58) - 20mcg/0.5ml Injectable suspension 14,139,396 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
N02BE01 TYLENOL B Paracetamol - 100mg 100mg Suppository 190,826 L.L
R03AK12 ZEPHIRUS B Salmeterol - 20mcg, Budesonide - 240mcg Capsule, inhalation 1,678,459 L.L
S01AE01 OFLOX B Ofloxacin - 0.3% 0.3% Drops solution 366,869 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated L.L
A10BK01 FORXIGA B Dapagliflozin - 10mg 10mg Tablet, film coated 2,927,964 L.L
C03DA01 ALDACTONE B Spironolactone - 25mg 25mg Tablet 237,860 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg 250mg Tablet, film coated 349,399 L.L
J07CA LANTIGEN B B Streptococcus pneumoniae type 3 (antigenic extracts) - 63.2A.U./ml, Streptococcus pyogenes group A (antigenic extracts) - 126.2A.U./ml, Branhamella catarrhalis (antigenic extracts) - 39.9A.U./ml, Staphylococcus aureus (antigenic extracts) - 79.6A.U./ml, Haemophilus influenzae type b (antigenic extracts) - 50.2A.U./ml, Klebsiella pneumoniae (antigenic extracts) - 39.8A.U./ml Drops suspension 916,501 L.L
L04AA32 OTEZLA B Apremilast - 4x10mg- 4x20mg- 19x30mg Tablet, film coated 34,751,325 L.L
M01AH05 ARCOXIA B Etoricoxib - 60mg 60mg Tablet, film coated 1,685,178 L.L
A07EA06 CORTIMENT MMX B Budesonide - 9mg 9mg Tablet, prolonged release 8,996,996 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg/5ml 250mg/5ml Granules for suspension 1,120,782 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
N02BE01 TYLENOL B Paracetamol - 200mg 200mg Suppository 235,172 L.L
A07EC02 ASACOL B Mesalazine - 400mg 400mg Tablet, enteric coated 5,895,437 L.L
C09CA04 APROVEL B Irbesartan - 150mg 150mg Tablet, film coated 651,764 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
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
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