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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
G01AF12 LOMEXIN B Fenticonazole nitrate - 200mg 200mg Ovule 810,359 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 581,884 L.L
J01XX08 ZYVOX B Linezolide - 600mg 600mg Tablet 35,584,461 L.L
L01BB02 PURI-NETHOL B Mercaptopurine - 50mg 50mg Tablet 830,495 L.L
M01AH05 ARCOXIA B Etoricoxib - 60mg 60mg Tablet, film coated 1,685,178 L.L
N04BB01 SYMMETREL B Amantadine - 100mg 100mg Capsule 568,253 L.L
N06AX11 REMERON SOLTAB B Mirtazapine - 30mg 30mg Tablet, orodispersible 1,486,290 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
C07AG02 DILATREND B Carvedilol - 6.25mg 6.25mg Tablet, scored 364,181 L.L
G01AF12 LOMEXIN B Fenticonazole nitrate - 600mg 600mg Ovule 850,727 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 581,884 L.L
L01BB04 LITAK 10 B Cladribine - 2mg/ml 2mg/ml Injectable solution 130,295,163 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 631,606 L.L
L04AA10 RAPAMUNE B Sirolimus - 1mg 1mg Tablet L.L
A03CA02 LIBRAX DRAGEES B Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 435,405 L.L
C09DA08 VOTUM PLUS B Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 900,374 L.L
G01AF12 LOMEXIN "T" B Fenticonazole nitrate - 1,000mg 1,000mg Ovule 909,037 L.L
L01BB04 LITAK 10 B Cladribine - 10mg/5ml 10mg/5ml Injectable solution 39,016,157 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 75mg 75mg Capsule, sustained release 732,394 L.L
B01AA07 SINTROM B Acenocoumarol - 4mg 4mg Tablet 490,183 L.L
H02AB02 DECADRON B Dexamethasone - 0.5mg 0.5mg Tablet, scored 393,218 L.L
L01BB04 MAVENCLAD B Cladribine - 10mg 10mg Tablet 200,244,812 L.L
N02BE01 PANADOL JOINT B Paracetamol - 665mg 665mg Tablet, film coated, prolonged release 291,614 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.7mg 0.7mg Tablet 2,478,046 L.L
L04AA18 CERTICAN B Everolimus - 0.5mg 0.5mg Tablet L.L
B05BA10 OLIMEL N9E B Glucose solution - 27.5%, Amino acids solution - 14.2%, Lipid emulsion - 20%, Sodium - 70mmol/2l, Potassium - 60mmol/2l, Magnesium - 8mmol/2l, Calcium - 7mmol/2l, Phosphate - 30mmol/2l, Acetate - 107mmol/2l, Chloride - 90mmol/2l, Azote - 18g/2l Injectable emulsion 4,711,512 L.L
C07AG02 DILATREND B Carvedilol - 25mg 25mg Tablet, scored 598,010 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
J02AA01 AMBISOME B Liposomal Amphotericin B - 50mg 50mg Injectable powder for liposomal dispersion 13,126,040 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
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    172
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