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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
L04AX07 TECFEO 240 G Dimethyl Fumarate - 240mg 240mg Capsule, delayed release 67,784,092 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
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 20mg/ml 20mg/ml Injectable concentrated solution+diluent 6,574,078 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 20mg/ml 20mg/ml Injectable concentrated solution+diluent 6,574,078 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
J05AX12 TIVICAY B Dolutegravir - 50mg 50mg Tablet, film coated 54,508,037 L.L
J05AR13 TRIUMEQ B Dolutegravir - 50mg, Abacavir sulfate - 600mg, Lamivudine - 300mg Tablet, film coated 74,756,237 L.L
S01ED51 TWINZOL G Dorzolamide HCl - 2%, Timolol - 0.5% Drops solution 632,950 L.L
J01AA02 TOLEXINE G Doxycycline (monohydrate) - 100mg 100mg Tablet, microgranules 589,947 L.L
R05CA12 TOUCALM G Dried Ivy leaf extract - 0.7g/100ml 0.7g/100ml Syrup 300,765 L.L
S01XA20 TEARS NATURALE B Duasorb - 0.4% 0.4% Drops solution 189,482 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 0.75mg/0.5ml 0.75mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 1.5mg/0.5ml 1.5mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 3mg/0.5ml 3mg/0.5ml Injectable solution 10,165,201 L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 4.5mg 4.5mg/0.5ml Injectable solution 10,165,201 L.L
J05AR03 TRUVADA B Emtricitabine - 200mg, Tenofovir disoproxil - 245mg Tablet, film coated 20,507,286 L.L
L01EB02 TARESSA 100 G Erlotinib (HCl) - 100mg 100mg Tablet, film coated 82,247,256 L.L
L01EB02 TARESSA 150 G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 98,617,813 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 53,437,592 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
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
R01AD08 TICANASE G Fluticasone propionate - 50mcg/actuation 12g/Bottle Spray, suspension 405,840 L.L
D07CC01 TOPIZONE G Fusidic acid - 20mg/g, Betamethasone (valerate) - 1mg/g Cream 216,359 L.L
S01AE06 TYMER G Gatifloxacin (sesquihydrate) - 3mg/ml 3mg/ml Drops solution 427,342 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 600,698 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 1,662,333 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
S02AA30 TYOTOCIN B Hexylresorcinol - 0.1%, Antipyrine - 5%, Benzocaine - 1.25%, Tyrothricin - 0.05% Drops solution 409,552 L.L
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