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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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ATC Name B/G Ingredients Dosage Form Price
N01BB58 ARTICAINE MEDIS ADRENALINE G Articaine HCl - 40mg/ml, Adrenaline - 0.07mg/ml Injectable solution 1,881,380 L.L
B05DB DIANEAL PD4 CYCLER 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,150,329 L.L
C05CA53 DAFLON B Hesperidin - 50mg, Diosmin - 450mg Tablet, film coated 627,574 L.L
G04BX14 PRIXETIN 60 G Dapoxetine (hydrochloride) - 60mg Tablet, film coated 1,479,123 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
N01BB58 ORABLOC G Articaine HCl - 4%, Epinephrine (tartrate) - 1/100.000 Injectable solution 2,308,721 L.L
B05DB DIANEAL PD4 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,111,506 L.L
C05CA53 DAFLON B Hesperidin - 50mg, Diosmin - 450mg Tablet, film coated 1,191,988 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
B05DB DIANEAL PD4 CYCLER 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,150,329 L.L
C05CA53 DAFLON B Hesperidin - 100mg, Diosmin - 900mg Tablet, film coated 1,256,493 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
B05XA PEDITRACE B Sodium selenite 5H2O (anhydrous) - 6.66mcg/ml, Sodium fluoride - 126mcg/ml, Potassium iodide - 1.31mcg/ml, Zinc chloride - 521mcg/ml, Copper chloride - 53.7mcg/ml, Manganese chloride 4H2O - 3.6mcg/ml Injectable concentrated solution 4,749,139 L.L
C05CA54 GINKOR FORT B Heptaminol HCl - 0.300g, Troxerutine - 0.300g, Ginkgo biloba extract - 0.014g Capsule 681,328 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
V06DD KETOSTERIL B Calcium - 0.05g, Total nitrogen - 36mg, L-Tyrosine - 30mg, L-Histidine - 38mg, L-Tryptophan - 23mg, L-Threonine - 53mg, L-Lysine Monoacetate - 105mg, Alpha Hydroxyanalogue-DL-Methionine, Calcium Salt - 59mg, Alpha Ketoanalogue-Valine,Calcium Salt - 86mg, Alpha Ketoanalogue-Phenylalanine,Calcium Salt - 68mg, Alpha-Ketoanalogue- Leucine,Calcium Salt - 101mg, Alpha-Ketoanalogue-DL-isoleucine,Calcium Salt - 67mg Tablet, film coated 3,950,897 L.L
B03AD MALTOFER FOL B Folic acid - 0.35mg, Iron trivalent (hydroxide polymaltose) - 100mg Tablet, chewable 854,684 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
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 572,634 L.L
V07AB01 ARWAN WFI G Water for injection - Water for injection, irrigation 399,915 L.L
B03AD EURO-FER CF G Folic acid - 0.5mg, Vitamin C - 200mg, Ferrous fumarate - 300mg Capsule 706,861 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
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 393,746 L.L
V07AB01 EAU POUR PREPARATION INJ. G Water for injection - Water for injection, irrigation 3,385,139 L.L
B03AD VITA-FERIN C G Ferrous fumarate - 300mg, Folic acid - 0.5mg, Vitamin C - 200mg Capsule 716,268 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 L.L
R06AD52 CODOPALM G Promethazine HCl - 5mg/5ml, Sodium gentisate - 0.5mg/5ml Syrup 149,742 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
B03AD VITEXFER G Folic acid - 1mg, Ascorbic acid - 200mg, Iron ferrous fumarate - 100mg Tablet, film coated 791,523 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL FREEZE-DRIED) BioTech Rotavirus bovine-human , live attenuated - Suspension 2,822,069 L.L
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