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
|