EMEA-002692-PIP01-19
Key facts
| Active substance |
Lonapegsomatropin
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/0275/2020
|
| PIP number |
EMEA-002692-PIP01-19
|
| Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
| Condition(s) / indication(s) |
Treatment of growth hormone deficiency
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Ascendis Pharma Endocrinology Division A/S
E-mail: MedicalAffairs@ascendispharma.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-002692-PIP01-19
|
| Compliance opinion date |
04/09/2020
|
| Compliance outcome |
negative
|