European Medicines Agency - Human Medicines - Medicines for children - EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP

Opinions and decisions on PIP applications
EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP
Click on a column heading to sort alphabetically or by date. [documento orginal únicamente

'W' - decision granting a waiver in all age groups for all conditions / indications
'P' - decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s)
'PM' – decision on the application for modification of an agreed PIP

W/P/PM
Product name Therapeutic area
Decision date
Published date
Procedure and EMEA decision numbers
Contact point for public enquiries

Example:
P - Purified diphtheria toxoid, Purified tetanus toxoid, Five component acellular pertussis [Purified Pertussis Toxoid, Purified Filamentous Haemagglutinin, Purified Fimbriae Types 2 and 3, and Purified Pertactin], Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 and Type 3 (Saukett), Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PEDIACEL) Vaccines 31/03/2009 18/05/09 EMEA-000278-PIP01-07-M01
P/64/09
Applicant: Sanofi Pasteur MSD SNC
E-mail: piplan@spmsd.com
Country: France
Phone: +33 437284000
Fax: Not available


abrir aquí para acceder al muy extenso documento que describe todas las moléculas farmacológicas en análisis de la EMEA:
European Medicines Agency - Human Medicines - Medicines for children - EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP