Product Information

Within this section of the website, you will find patient information regarding our licensed products. These information sources include patient information leaflets, the Summary of Product Characteristics and European Public Assessment Reports.

  • The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and provides important information about taking our licensed products.
  • The Summary of Product Characteristics (SmPC) is a description of a medicinal product including recommendations for its use.
  • The European Public Assessment Report (EPAR) explains how the European Medicines Agency (EMA) assessed the medicine to recommend its authorisation in the EU and its conditions of use.

Please note that this information is specific to Ireland and is not intended to replace the advice of a qualified doctor or pharmacist.

Products
European Public Assessment Report



Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
Abraxane® (paclitaxel formulated as albumin bound nanoparticles: nab-paclitaxel)European Public Assessment ReportSummary of Product Characteristics
Imnovid® (pomalidomide)European Public Assessment ReportSummary of Product Characteristics
Otezla® 10MG, 20MG, 30MG (apremilast)European Public Assessment ReportSummary of Product Characteristics
Otezla® 30MG (apremilast)European Public Assessment ReportSummary of Product Characteristics
Revlimid® 2.5 MG, 5MG, 7.5MG, 10MG, 15MG, 20MG, 25MG (lenalidomide)European Public Assessment ReportSummary of Product Characteristics
THALIDOMIDE CELGENE™ (thalidomide)European Public Assessment ReportSummary of Product Characteristics
VIDAZA® (azacitidine)European Public Assessment ReportSummary of Product Characteristics

ABRAXANE®, IMNOVID®, OTEZLA®, REVLIMID®, THALIDOMIDE CELGENE™ , VIDAZA® are registered trademarks of Celgene Corporation.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects, you can help provide more information on the safety of this medicine.


UK-CELG170172k(1)
Date of preparation: November 2018