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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
A11BA VITALIPID N INFANT B Vitamin A - 230IU/ml, Vitamin D2 - 40IU/ml, Vitamin E - 0.7IU/ml, Vitamin K1 - 20mcg/ml Injectable concentrate for solution 2,448,481 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
L04AA29 XELJANZ XR B Tofacitinib - 11mg 11mg Tablet, extended release 78,687,316 L.L
M01AH01 CELEBREX B Celecoxib - 200mg 200mg Capsule 1,126,140 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 1.5mg 1.5mg Tablet, extended release 1,847,783 L.L
R03AK07 SYMBICORT TURBUHALER B Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Inhalation powder 1,689,210 L.L
R07AA01 SURVANTA B Colfosceril palmitate - 200mg/8ml 200mg/8ml Suspension 36,957,499 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 2,218,684 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
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
C09CA06 ATACAND B Candesartan cilexetil - 8mg 8mg Tablet 526,786 L.L
G04BE30 LIF-DOL B Yohimbin HCl - 3.3mg, Thiamine - 5.5mg, Cyanocobalamine - 0.015mg, Ferrous fumarate - 50mg, Sildenafil citrate - 10mg Tablet, coated 231,653 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
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 1mg 1mg Capsule, prolonged release L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
C09CA06 BLOPRESS B Candesartan cilexetil - 8mg 8mg Tablet 847,965 L.L
G04BX ROWATINEX B Olive oil - 33mg, Cineol - 3mg, Fenchone - 4mg, Anethol - 4mg, Borneol - 10mg, Camphene - 15mg, ?-Pinene - 6.2mg, ?-Pinene - 24.8mg Capsule 255,330 L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule 197,706,574 L.L
L04AA31 AUBAGIO B Teriflunomide - 14mg 14mg Tablet, film coated 38,773,533 L.L
N02BE01 PANADOL JOINT B Paracetamol - 665mg 665mg Tablet, film coated, prolonged release 291,614 L.L
N04BC09 NEUPRO B Rotigotine - 2mg/24h 2mg/24h Patch 4,427,961 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 9mcg/Inhalation, Budesonide - 320mcg/Inhalation Inhalation powder 3,378,420 L.L
L04AD02 ADVAGRAF B Tacrolimus monohydrate - 3mg 3mg Capsule, prolonged release 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
C05AX05 PROCTO GLYVENOL B Lidocaine - 40mg, Tribenoside - 400mg Suppository 399,121 L.L
G04BX14 PRILIGY B Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 1,957,979 L.L
J07CA11 DIPHTHERIA, TETANUS,PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE B Diphteria Toxoid1 - ?25Lf (?30IU)/0.5ml, Tetanus toxoid1 - ?2.5Lf (?40IU)/0.5ml, Bordetella pertussis (Whole cell) - ?16OU (?4.0IU)/0.5ml, HBs Antigen (r DNA)1 - ?10mcg/0.5ml, H. Influenza type b, purified capsular polysaccharide2 - 10mcg/0.5ml, 1 adsorbed on aluminium phosphate, Al+++ - ?1.25mg , 2 conjugated to tetanos toxoid carrier protein - Injectable suspension 1,515,854 L.L
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