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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
R05X COLD-MED G Glyceryl guaiacolate - 15mg/5ml, Pseudoephedrine HCl - 15mg/5ml, Pyrilamine maleate - 6.25mg/5ml, Paracetamol - 120mg/5ml Syrup 386,515 L.L
V03AE02 FOSEAL-800 G Sevelamer HCl - 800mg 800mg Tablet, film coated 470,345 L.L
A03FA03 DOMPERIDONE BIOGARAN G Domperidone - 10mg 10mg Tablet, coated 116,914 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2 G Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 AMLINE G Amlodipine - 10mg 10mg Tablet 662,962 L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
J01AA02 DOXY 50 G Doxycycline (hyclate) - 50mg 50mg Tablet, coated 311,771 L.L
J01DH02 MEROZAN G Meropenem - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 1mg 1mg Tablet, coated 18,701,506 L.L
L01DB01 DOXORUBICINA TEDEC G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable concentrate for solution 2,015,764 L.L
M01AB05 CLOREN ADULTS G Diclofenac sodium - 100mg 100mg Suppository 598,970 L.L
N03AX12 PMS-GABAPENTIN G Gabapentin - 300mg 300mg Capsule 869,466 L.L
N05BA06 LORAZEPAM G Lorazepam - 1mg 1mg Tablet, scored 325,082 L.L
P01AB07 SECNOL G Secnidazole - 2g 2g Granules 842,589 L.L
R05X TRIMEDIL FORTE G O-(?-hydroxyethyl)-rutosides - 30mg, Ascorbic acid - 80mg, Dimethindene - 0.5mg, Phenylephrine HCl - 2.5mg, Paracetamol - 200mg Capsule 386,515 L.L
V03AE02 FOSEAL-800 G Sevelamer HCl - 800mg 800mg Tablet, film coated 7,977,094 L.L
A03FA03 FARCOTILIUM G Domperidone - 10mg 10mg Capsule, soft gelatin 146,479 L.L
A10BB12 AMEPRIDE G Glimepiride - 3mg 3mg Tablet 215,015 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 154,450 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C08CA01 AMLOCARD 10 G Amlodipine (besylate) - 10mg 10mg Tablet 870,298 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,638,144 L.L
D04AB01 AVOCAINE G Lidocaine - 10% 10% Spray 620,855 L.L
J01AA02 DOXY 100 G Doxycycline (hyclate) - 100mg 100mg Tablet, coated 788,836 L.L
J01DH02 MIRAN G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 819,744 L.L
J05AF10 ENTECAVIR BIOGARAN G Entecavir - 1mg 1mg Tablet, coated 19,080,319 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 2mg/ml 50mg/25ml Injectable concentrated solution 1,804,780 L.L
M01AB05 DICLO-DENK 100 RECTAL G Diclofenac sodium - 100mg 100mg Suppository 310,428 L.L
N01AF03 THIOPENTAL PANPHARMA G Thiopental - 500mg 500mg Injectable powder for solution 8,446,717 L.L
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