EMEA-000013-PIP01-07-M03

Key facts

Active substance
recombinant L-asparaginase
Therapeutic area
Oncology
Decision number
P/0084/2013
PIP number
EMEA-000013-PIP01-07-M03
Pharmaceutical form(s)
Powder for solution for injection or infusion
Condition(s) / indication(s)
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
Route(s) of administration
  • Intravenous use
  • Intramuscular use
Contact for public enquiries
Medac Gesellschaft für klinische Spezialpräparate mbH

E-mail: j.kuehnel@medac.de
Country: Germany
Tel. +49 41038006413
Fax: +49 41038009130

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000013-PIP01-07-M03
Compliance opinion date
14/06/2013
Compliance outcome
positive

Decision

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