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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
L01EJ01 JAKAVI B Ruxolitinib - 20mg 20mg Tablet 326,608,760 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 1.5mg 1.5mg Tablet, extended release 1,847,783 L.L
A07BA01 BIOCARBON B Activated charcoal - 250mg 250mg Tablet 1,361,312 L.L
A10BH05 TRAJENTA B Linagliptin - 5mg 5mg Tablet, film coated 3,213,127 L.L
B01AX05 ARIXTRA B Fondaparinux sodium - 2.5mg/0.5ml 2.5mg/0.5ml Injectable solution 5,341,774 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 500mg 500mg Capsule 659,123 L.L
A07BA51 CARBOSYLANE B Simethicone (blue-red) - 45mg (blue-red), Activated charcoal (blue-red) - 140mg (blue-red) Capsule 585,915 L.L
B01AX05 ARIXTRA B Fondaparinux sodium - 7.5mg/0.6ml 7.5mg/0.6ml Injectable solution 12,004,668 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
L01EK01 INLYTA B Axitinib - 5mg 5mg Tablet, film coated 184,486,511 L.L
M01AH01 CELEBREX B Celecoxib - 200mg 200mg Capsule 1,126,140 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
B02AA02 EXACYL B Tranexamic acid - 500mg/5ml 500mg/5ml Injectable solution 748,520 L.L
L01EK01 INLYTA B Axitinib - 1mg 1mg Tablet, film coated 57,595,789 L.L
N04BC09 NEUPRO B Rotigotine - 2mg/24h 2mg/24h Patch 4,427,961 L.L
A07BC05 SMECTALIA B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
C09CA03 DIOVAN B Valsartan - 160mg 160mg Tablet, film coated 846,621 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
L01EL01 IMBRUVICA B Ibrutinib - 140mg 140mg Tablet, film coated 187,342,573 L.L
L04AA29 XELJANZ B Tofacitinib - 5mg 5mg Tablet 80,685,473 L.L
N02BE01 PANADOL JOINT B Paracetamol - 665mg 665mg Tablet, film coated, prolonged release 291,614 L.L
N04BC09 NEUPRO B Rotigotine - 4mg/24h 4mg/24h Patch 7,292,823 L.L
S01AA13 FUCITHALMIC VISCOUS B Fusidic acid - 10mg/g 1% Drops 373,588 L.L
A07BC05 SMECTALIA STRAWBERRY B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
B02BA01 KONAKION MM PEDIATRIC B Phytomenadione - 2mg/0.2ml 2mg/0.2ml Solution 442,124 L.L
J01MA12 TAVANIC B Levofloxacin - 500mg 500mg Tablet, film-scored 1,150,329 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 L.L
N04BC09 NEUPRO B Rotigotine - 6mg/24h 6mg/24h Patch 9,427,593 L.L
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