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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
L04AA27 GILENYA B Fingolimod - 0.5mg 0.5mg Capsule 159,392,560 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 2,218,684 L.L
D10AD06 AKLIEF B Trifarotene - 50mcg/g 50mcg/g Cream 4,359,425 L.L
J07BK01 VARIVAX B Varicella virus, live attenuated - 1350PFU Injectable powder for suspension+diluent 4,102,751 L.L
L01EM03 PIQRAY B Alpelisib - 150mg 150mg Tablet, film coated 359,195,954 L.L
R03AK06 SERETIDE DISKUS 500 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 500mcg/inhalation Inhalation powder 3,199,689 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
L01EM03 PIQRAY B Alpelisib - 200mg, Alpelisib - 50mg 150mg Tablet, film coated 359,195,954 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 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
L01EM03 PIQRAY B Alpelisib - 200mg 200mg Tablet, film coated 359,195,954 L.L
R06AX29 LABIXTEN B Bilastine - 20mg 20mg Tablet 584,571 L.L
A08AA01 LOMAIRA B Phentermine Hydrochloride - 8mg 8mg Tablet 6,138,673 L.L
B02BX01 DICYNONE B Etamsylate - 250mg/2ml 250mg Injectable solution 482,439 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg 250mg Tablet, film coated 349,399 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
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
N04BB01 PK-MERZ B Amantadine (sulfate) - 100mg 100mg Tablet, film coated 1,382,814 L.L
R06AX29 LABIXTEN B Bilastine - 2.5mg/ml 2.5mg/ml Solution 463,626 L.L
L02BA03 FASLODEX B Fulvestrant - 250mg/5ml 250mg/5ml Injectable solution L.L
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A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
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C09CA06 ATACAND B Candesartan cilexetil - 8mg 8mg Tablet 526,786 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg/5ml 250mg/5ml Granules for suspension 1,120,782 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
L04AA29 XELJANZ B Tofacitinib - 5mg 5mg Tablet 80,685,473 L.L
M01AG01 PONSTAN FORTE B Mefenamic acid - 500mg 500mg Tablet, film coated 219,046 L.L
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