Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
lonapegsomatropin
Table of contents
Overview
Lonapegsomatropin Ascendis Pharma is a medicine that is used to improve growth in children and adolescents who do not produce enough growth hormone (growth hormone deficiency or GHD). The medicine is intended for children and adolescents from 3 up to 18 years of age.
GHD is rare, and Lonapegsomatropin Ascendis Pharma was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 October 2019. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3192213.
Lonapegsomatropin Ascendis Pharma contains the active substance lonapegsomatropin.
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Lonapegsomatropin Ascendis Pharma : EPAR - Medicine Overview (PDF/93.55 KB)
First published: 04/02/2022
EMA/740430/2021 -
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Lonapegsomatropin Ascendis Pharma : EPAR - Risk management plan summary (PDF/1.24 MB)
First published: 04/02/2022
Authorisation details
Product details | |
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Name |
Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
|
Agency product number |
EMEA/H/C/005367
|
Active substance |
Lonapegsomatropin
|
International non-proprietary name (INN) or common name |
lonapegsomatropin
|
Therapeutic area (MeSH) |
Growth and Development
|
Anatomical therapeutic chemical (ATC) code |
H01AC09
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Ascendis Pharma Endocrinology Division A/S
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
11/01/2022
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Contact address |
Tuborg Boulevard 12 |
Product information
20/12/2022 Skytrofa (previously Lonapegsomatropin Ascendis Pharma) - EMEA/H/C/005367 - PSUSA/00010969/202202
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pituitary and hypothalamic hormones and analogues
Therapeutic indication
Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD])