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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
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 0.275g/100g, Lidocaine - 5g/100g, Zinc oxide - 18g/100g, Aluminium Subacetate - 3.5g/100g Ointment 330,585 L.L
R03AC02 SALBUTAMOL SULFATE G Salbutamol (sulfate) - 2mg 2mg Tablet, scored 401,873 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 10mg 10mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 10mg 10mg Tablet, coated 517,379 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 18,264,981 L.L
L04AA27 SCLEMOD G Fingolimod Hydrochloride - 0.5mg 0.5mg Capsule 17,079,643 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 12.5mg 12.5mg Capsule 36,042,560 L.L
R03AK06 SEROFLO 500 G Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 500mcg/inhalation Inhalation suspension 2,031,890 L.L
L01EX01 SUNITINIB AQVIDA G Sunitinib maleate - 12.5mg 12.5mg Capsule, hard 35,585,027 L.L
R03AK06 SEROFLO-S 125 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 125mcg/inhalation Inhalation suspension 1,212,146 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 25mg 25mg Capsule 64,804,314 L.L
R03AK06 SEROFLO 250 G Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,580,359 L.L
R03AK06 SEROFLO-S 250 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,725,494 L.L
L01EX01 SOVIDEX G Sunitinib maleate - 50mg 50mg Capsule 118,623,323 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
L01EX01 SUNITINIB AQVIDA G Sunitinib maleate - 50mg 50mg Capsule, hard 130,270,326 L.L
A11CC05 SUN-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 935,570 L.L
D10AF02 SPOTEX G Erythromycin - 4% 4% Gel 854,684 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 20mg 20mg Tablet, coated 517,379 L.L
N02BE01 SICADOL G Paracetamol - 1000mg 1000mg Tablet 423,310 L.L
N02BE01 SULDEX B G Paracetamol - 150mg 150mg Suppository 117,746 L.L
J01DD01 STOPAREN G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 213,671 L.L
N02BE01 SULDEX 250 G Paracetamol - 250mg 250mg Suppository 127,985 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 5mg 5mg Tablet, film coated 387,027 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 4.2g/100ml 4.2g/100ml Injectable solution 742,370 L.L
G04CA04 SILODOSINE ARROW G Silodosine - 4mg 4mg Capsule 732,394 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 8.4g/100ml 8.4% Injectable solution 959,565 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 160mg 160mg Tablet, scored 357,462 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 4mg 4mg Capsule 555,007 L.L
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