The First Paediatric Use Marketing Authorisation: A Case Study-Reference-Cited by-同舟云学术

The First Paediatric Use Marketing Authorisation: A Case Study

Published:2015-03 Issue:2 Volume:49 Page:297-301
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Watson John,Nowacki Kulminder

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479014537260.pdf

Reference12 articles.

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2. Paediatric Working Party. Assessment of the paediatric needs for epilepsy. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004047.pdf. Published September 20, 2006. Accessed January 7, 2014.

3. Roche. Hypnovel SmPC, eMC, Datapharm Communications Ltd. http://www.medicines.org.uk/emc/medicine/1692/SPC/Hypnovel+10mg+2ml+solution+for+injection/#INDICATIONS. Published April 2012. Accessed January 7, 2014.

4. European Commission. Regulation (Ec) No 1901/2006 of the European Parliament and of the council. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf. Published December 12, 2006. Accessed January 7, 2014.

5. Bryson S. Experience of PIP/waiver/deferral process from an SME perspective. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500013719.pdf. Published October 23, 2009. Accessed January 7, 2014.