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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
R03AK06 SEROFLO-S 250 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,725,494 L.L
A02BC DANLOX QUICK G Omeprazole - 20mg, Sodium bicarbonate - 1680mg Powder 1,323,685 L.L
D07XC01 BETA-MICOTER G Betamethasone (dipropionate) - 0.5mg/g, Clotrimazole - 10mg/g Cream 415,951 L.L
J01CR05 TAZOBACT Piperacillin sodium - 4g, Tazobactam (sodium) - 500mg 783,460 L.L
M01AE51 FLUMIX BENTA G Ibuprofen - 200mg, Guaifenesin - 200mg, Chlorpheniramine maleate - 2mg, Phenylephrine HCl - 5mg Tablet, film coated 460,746 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
D07XC01 DIPROSALIC B Salicylic acid - 30mg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 352,087 L.L
J01CR50 FLUMOX G Flucloxacillin (monohydrate) - 250mg, Amoxicillin (trihydrate) - 250mg Capsule 348,055 L.L
J07BD52 PRIORIX B Rubella virus live attenuated - ?10³ CCID50, Mumps virus live attenuated - ?103.7 CCID50, Measles virus live attenuated - ?10³ CCID50 Injectable lyophilised powder for solution+diluent 1,142,266 L.L
R03AK07 SYMBICORT TURBUHALER B Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Inhalation powder 1,689,210 L.L
D07XC03 ELICA M G Mometasone furoate - 0.1%, Miconazole nitrate - 2% Cream 459,594 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
R03AK07 BUFOMIX EASYHALER G Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Metered dose inhaler 2,365,163 L.L
D07XC03 ELICASAL G Mometasone furoate - 1mg/g, Salicylic acid - 50mg/g Ointment 462,282 L.L
J07BD52 MEASLES, MUMPS AND RUBELLA VACCINE LIVE ATTENUATED (FREEZE-DRIED) MMR G Rubella virus live attenuated - ?1000CCID50 /0.5ml, Mumps virus live attenuated - ?5000CCID50 /0.5ml, Measles virus live attenuated - ?1000CCID50 /0.5ml Injectable freeze dried powder + diluent 739,113 L.L
R03AK07 BUFOMIX EASYHALER G Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Metered dose inhaler 1,182,581 L.L
A07BA51 CARBOSYLANE B Simethicone (blue-red) - 45mg (blue-red), Activated charcoal (blue-red) - 140mg (blue-red) Capsule 585,915 L.L
D07XC04 TRAVOCORT B Diflucortolone valerate - 0.1%, Isoconazole nitrate - 1% Cream 435,405 L.L
J07BF03 POLIOMYELITIS VACCINE INACTIVATED B Poliomyelitis virus type 1 inactivated - 40D.U, Poliomyelitis virus type 2 inactivated - 8D.U, Poliomyelitis virus type 3 inactivated - 32D.U Injectable suspension 1,206,771 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 9mcg/Inhalation, Budesonide - 320mcg/Inhalation Inhalation powder 3,378,420 L.L
A07BA51 EUCARBON B Rhubarbe - 25mg, Sulfur - 50mg, Senna - 105mg, Vegetal charcoal - 180mg Tablet 795,555 L.L
D07XC04 AZONIT - D G Diflucortolone valerate - 1mg/g, Isoconazole nitrate - 10mg/g Cream 225,766 L.L
J07BG01 RABIVAX-S (RABIES VACCINE INACTIVATED) BioTech Freeze dried inactivated purified rabies antigen (Pitman Moore PM3218 as virus strain) - Injectable freeze dried material 1,552,138 L.L
R03AK07 BUFOMIX EASYHALER G Formoterol fumarate dihydrate - 9mcg, Budesonide - 320mcg Metered dose inhaler 2,365,163 L.L
D08AC52 CYTEAL Solution Antiseptique G Chlorhexidine digluconate - 0.5ml/100ml, Hexamidine - 0.1g/100ml, Chlorocresol - 0.3g/100ml Solution 362,420 L.L
J07BH01 ROTATEQ ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT B Rotavirus G1, live attenuated - ?2.2x106 IU, Rotavirus G2, live attenuated - ?2.8x106 IU, Rotavirus G3, live attenuated - ?2.2x106 IU, Rotavirus G4, live attenuated - ?2.0x106 IU, Rotavirus P1, live attenuated - ?2.3x106 IU Suspension 4,508,592 L.L
R03AK07 FORACORT 200 G Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 200mcg/inhalation Metered dose inhaler 2,159,555 L.L
D08AC52 CYTEAL Solution Antiseptique G Chlorhexidine digluconate - 0.5ml/100ml, Hexamidine - 0.1g/100ml, Chlorocresol - 0.3g/100ml Solution 616,977 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 L.L
R03AK07 FORACORT 400 G Formoterol fumarate - 4.5mcg/inhalation, Budesonide - 400mcg/inhalation Metered dose inhaler 3,104,276 L.L
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