Key facts

Active Substance
  • Recombinant human granulocyte colony stimulating factor
  • recombinant human albumin fusion protein
Therapeutic area
Oncology
Decision number
P/36/2011
PIP number
P/36/2011
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Prevention of chemotherapy induced neutropenia
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Teva Pharmaceuticals Europe B.V

info@ratiopharm.de
Germany
Phone: +49 73140202
Fax: +49 7314027832

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/36/2011: EMA decision of 28 January 2011 on the refusal of a product specific waiver for recombinant human granulocyte colony stimulating factor / recombinant human albumin fusion protein (EMEA-001042-PIP01-10) in acc...

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