Key facts

Invented name
  • Akynzeo
  • Akynzeo
Active Substance
  • Fosnetupitant
  • Palonosetron
Therapeutic area
Other
Decision number
P/0358/2016
PIP number
EMEA-001198-PIP02-16
Pharmaceutical form(s)
Powder for solution for infusion
Condition(s) / indication(s)
Prevention of chemotherapy-induced nausea and vomiting
Route(s) of administration
Intravenous use
Contact for public enquiries

Helsinn Birex Pharmaceuticals Limited

Switzerland
E-mail: paediatrics-netu@helsinn.com
Tel.: +41 919851950
Fax: +41 919852195

Decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Decision date

Decision

P/0358/2016: EMA decision of 21 December 2016 on the refusal of a product specific waiver for fosnetupitant / palonosetron (Akynzeo), (EMEA-001198- PIP02-16)

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