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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
M01AB55 DIFEN B12 G Diclofenac sodium - 75mg, Prednisolone sodium phosphate - 10.08mg, Hydroxocobalamin acetate - 10.44mg Injectable solution 978,317 L.L
B05BC01 SOLUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 603,320 L.L
J06BA02 PRIVIGEN BioHuman Immunoglobulin human - 5g/50ml 10% Injectable solution 42,577,976 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 329,815 L.L
J06BA02 CLAIRYG BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 74,469,269 L.L
M01AC01 INFLACAM G Piroxicam - 20mg/ml 20mg/ml Injectable solution 190,826 L.L
N01BB58 ARTINIBSA 4% WITH EPINEPHRINE 1/100000 B Articaine HCl - 4%, Epinephrine - 1/100.000 Injectable solution 1,968,729 L.L
N03AX14 KEPAM MS G Levetiracetam - 500mg/5ml 500mg/5ml Injectable solution 9,170,015 L.L
N07BC01 BUVIDAL B Buprenorphine - 8mg 8mg Injectable solution prolonged release 8,524,771 L.L
N07BC01 BUVIDAL B Buprenorphine - 16mg 16mg Injectable solution prolonged release 8,524,771 L.L
N07BC01 BUVIDAL B Buprenorphine - 24mg 24mg Injectable solution prolonged release 8,524,771 L.L
N07BC01 BUVIDAL B Buprenorphine - 32mg 32mg Injectable solution prolonged release 8,524,771 L.L
N07BC01 BUVIDAL B Buprenorphine - 64mg 64mg Injectable solution prolonged release 34,835,645 L.L
N07BC01 BUVIDAL B Buprenorphine - 96mg 96mg Injectable solution prolonged release 34,835,645 L.L
N07BC01 BUVIDAL B Buprenorphine - 128mg 128mg Injectable solution prolonged release 34,835,645 L.L
J07BD52 M-M-R II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE) B Rubella virus live attenuated - , Mumps virus live attenuated - , Measles virus live attenuated - Injectable solution+diluent 12,924,401 L.L
A02BC01 ULCAZAL G Omeprazole (sodium) - 40mg 40mg Injectable sterile lyophilised powder for solution 895,895 L.L
A02BC01 ULCAZAL G Omeprazole (sodium) - 40mg 40mg Injectable sterile lyophilised powder for solution 5,916,747 L.L
J01XA01 ZERMACIN G Vancomycin (HCl) - 0.5g 0.5g Injectable sterile lyophilised powder for solution 840,861 L.L
J01XA01 ZERMACIN G Vancomycin (HCl) - 0.5g 0.5g Injectable sterile lyophilised powder for solution 5,875,791 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable sterile lyophilised powder for solution 995,723 L.L
J01DH02 AROPEM G Meropenem - 0.5g 0.5g Injectable sterile lyophilised powder for solution 19,022,727 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable sterile lyophilised powder for solution 995,723 L.L
J01DH02 AROPEM G Meropenem - 1g 1g Injectable sterile lyophilised powder for solution 19,022,727 L.L
J01DD04 LEBACEF G Ceftriaxone - 1g 1g Injectable sterile powder for solution + lidocaine solvent 508,100 L.L
J01DD04 LEBACEF G Ceftriaxone - 1g 1g Injectable sterile powder for solution + lidocaine solvent 508,100 L.L
J07AJ51 BOOSTRIX B Diphteria toxoid purified - ?2.5Lf/0.5ml, Tetanus toxoid purified - ?5Lf/0.5ml, Bordetella Pertussis Antigens: toxoid - 8mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 8mcg/0.5ml, Pertactine - 2.5mcg Al3+/0.5ml, Aluminium hydroxide - 0.3mg Al3+/0.5ml, Aluminium Phosphate - 0.2mg/0.5ml Injectable suspension 1,394,909 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
L03AB03 IMUKIN BioTech Interferon gamma - 100mcg/0.5ml 100mcg/0.5ml Injectable suspension 6,348,312 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
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