EMEA-000619-PIP02-10 - paediatric investigation plan
Pralatrexate
PIPHuman
Key facts
Active Substance
Pralatrexate
Therapeutic area
Oncology
Decision number
P/270/2010
PIP number
EMEA-000619-PIP02-10
Pharmaceutical form(s)
Solution for injection
Solution for infusion
Condition(s) / indication(s)
Treatment of Hodgkin lymphoma
Treatment of lymphoblastic non-Hodgkin lymphoma
Treatment of mature B-cell non-Hodgkin lymphoma
Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Route(s) of administration
Intravenous use
Intrathecal use
Contact for public enquiries
Allos Therapeutics Limited
pedinfo@allos.com United States Phone: +1 3034266262 Fax: +1 3034129160
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/270/2010: EMA decision of 6 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the
granting of a waiver for pralatrexate (EMEA-000619-PIP02-10)