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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
L01FX04 YERVOY BioTech Ipilimumab - 50mg/10ml 50mg/10ml Injectable solution 332,262,937 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 176,974 L.L
C07AG01 LABETALOL HYDROCHLORIDE INJECTION G Labetalol HCl - 100mg/20ml 100mg/20ml Injectable solution 2,955,110 L.L
L04AX03 METOJECT G Methotrexate disodium - 10mg/0.2ml 10mg/0.2ml Injectable solution 1,553,482 L.L
B05BA01 AMINOVEN 10% B Glacial Acetic Acid 99% - 5.297g/l, L-Proline - 15.0g/l, L-Alanine - 15.0g/l, Glycine - 14.0g/l, L-Histidine - 3.00g/l, L-Arginine - 12.0g/l, L-Valine - 6.20g/l, L-Tryptophan - 2.00g/l, L-Threonine - 4.40g/l, L-Phenylalanine - 5.10g/l, L-Methionine - 4.30g/l, L-Lysine (monoacetate) - 6.60g/l, L-Leucine - 7.40g/l, L-Isoleucine - 5.00g/l Injectable solution 951,440 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 137,902 L.L
G02AX OXYTOCIN 10 PANPHARMA 10 UI-1ML G Oxytocin - 10IU/ml 10IU/ml Injectable solution 525,442 L.L
L04AX03 EBETREXAT G Methotrexate - 15mg/1.5ml 15mg/1.5ml Injectable solution 2,135,366 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 355,798 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 155,139 L.L
G02AX OXYTOCIN 10 PANPHARMA 10 UI-1ML G Oxytocin - 10IU/ml 10IU/ml Injectable solution 525,442 L.L
L04AX03 METOJECT G Methotrexate disodium - 15mg/0.3ml 15mg/0.3ml Injectable solution 1,968,729 L.L
A03BB01 ANTIPAN G Hyoscine N butylbromide - 20mg/ml Injectable solution 2,557,140 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
L04AX03 METOJECT G Methotrexate disodium - 20mg/0.4ml 20mg/0.4ml Injectable solution 2,134,022 L.L
R03DX05 XOLAIR BioTech Omalizumab - 150mg 150mg Injectable solution 37,110,724 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
L01FX24 TECVAYLI BioTech Teclistamab - 10mg/ml 10mg/ml Injectable solution 95,166,436 L.L
L04AX03 METOJECT G Methotrexate disodium - 25mg/0.5ml 25mg/0.5ml Injectable solution 2,582,865 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 178,731 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 133,856 L.L
L01CA02 CELLCRISTIN G Vincristine sulfate - 1mg/ml 1mg/ml Injectable solution 1,166,025 L.L
L01FX24 TECVAYLI BioTech Teclistamab - 90mg/ml 90mg/ml Injectable solution 483,720,518 L.L
A03BB01 ? HYOSCINE BUTYLBROMIDE G Hyoscine butylbromide - 20mg/ml 20mg/ml Injectable solution 70,392 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
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