EMEA-001152-PIP02-16
Key facts
Active substance |
Recombinant modified human growth hormone
|
Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
Decision number |
P/0121/2017
|
PIP number |
EMEA-001152-PIP02-16
|
Pharmaceutical form(s) |
Solution for injection
|
Condition(s) / indication(s) |
Treatment of growth hormone deficiency
|
Route(s) of administration |
Subcutaneous use
|
Contact for public enquiries |
Richardson Associates Regulatory Affairs Ltd
|
Decision type |
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
|