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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
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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ATC Name B/G Ingredients Dosage Form Price
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 631,606 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.7mg 0.7mg Tablet 2,478,046 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.75mg 0.75mg Tablet, extended release 942,034 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.375mg 0.375mg Tablet, extended release 473,033 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 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
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule 197,706,574 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 9mcg/Inhalation, Budesonide - 320mcg/Inhalation Inhalation powder 3,378,420 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated 262,387,816 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
G04CA04 SILOSIN B Silodosine - 4mg 4mg Capsule 1,251,693 L.L
G04CA04 SILOSIN B Silodosine - 8mg 8mg Capsule 1,927,454 L.L
N06AX27 SPRAVATO B Esketamine - 28mg/device 28mg/device Solution 25,122,440 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 66,978,978 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 44,561,381 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
R03BB04 SPIRIVA RESPIMAT B Tiotropium bromide - 2.5mcg/dose 2.5mcg/dose Inhalation solution 3,000,800 L.L
R03BB06 SEEBRI BREEZHALER B Glycopyronium Bromide - 50mcg 50mcg Capsule, inhalation 2,687,685 L.L
N06BX06 SOMAZINA B Citicoline - 1000mg/sachet 1000mg/sachet Solution 974,286 L.L
N06BX06 SOMAZINA B Citicoline (sodium) - 1,000mg/4ml 1,000mg/4ml Injectable solution 787,492 L.L
D11AX22 SOOLANTRA B Ivermectin - 10mg/g 10mg/g Cream 2,154,180 L.L
D11AX22 SOOLANTRA B Ivermectin - 10mg/g 10mg/g Cream 1,053,573 L.L
H01CB02 SANDOSTATIN B Octreotide - 0.1mg/ml 0.1mg/ml Injectable solution 1,038,790 L.L
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