More medicines for children: impact of the EU paediatric regulation

Archives of Disease in Childhood
Sofia NordenmalmChrissi Pallidis

Abstract

This paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007. To investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure. We retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004-2006 and 2012-2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded. In 2004-2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012-2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004-2006 and seven in 2012-2014. There was a huge incre...Continue Reading

References

Apr 5, 2012·Clinical Pharmacology and Therapeutics·E Kimland, V Odlind
Jan 11, 2013·International Journal of Telemedicine and Applications·Per Egil Kummervold, Rolf Wynn
Aug 6, 2014·Orphanet Journal of Rare Diseases·Annemarie Rosan Kreeftmeijer-VegterPeter J de Vries
Nov 7, 2015·Archives of Disease in Childhood·Agnès Saint-RaymondSarah Branch

❮ Previous
Next ❯

Citations

Nov 8, 2018·British Journal of Clinical Pharmacology·Cécile OllivierLynne Yao
Sep 20, 2019·Archives of Disease in Childhood·Suzy HuijghebaertMyriam Van Winckel
Feb 8, 2019·European Journal of Clinical Pharmacology·Daria PutignanoMaurizio Bonati
Oct 11, 2019·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·F BautistaUNKNOWN Sociedad Española de Hematología y Oncología Pediátrica (SEHOP)
Jan 10, 2021·Archives of Disease in Childhood·Kalle Hoppu, Helena Fonseca
Jan 10, 2021·Journal of Pharmaceutical Sciences·Isa VieiraCarla Vitorino
Dec 6, 2020·Pharmaceutics·Bethany Faulkner, M Begoña Delgado-Charro
Feb 20, 2021·Frontiers in Medicine·Maddalena TomaUNKNOWN TEDDY European Network of Excellence for Paediatric Research
Mar 31, 2021·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·C M Díaz-CanejaC Arango
Apr 6, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Caroline Kofoed-DjursnerRagna Berthelsen
Jun 3, 2021·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·A Rubio-San-SimónL Moreno
May 21, 2021·Health Science Reports·Julia BackEstelle Naumburg
Jul 16, 2021·Archives of Disease in Childhood·Eveline E M van KampenElisabeth J Ruijgrok

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.