Skytrofa (previously Lonapegsomatropin Ascendis Pharma)

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lonapegsomatropin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 31/01/2023

Authorisation details

Product details
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
Additional monitoringAdditional 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.

OrphanOrphan

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
Marketing-authorisation holder
Ascendis Pharma Endocrinology Division A/S
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
11/01/2022
Contact address

Tuborg Boulevard 12
2900 Hellerup
Denmark

Product information

20/12/2022 Skytrofa (previously Lonapegsomatropin Ascendis Pharma) - EMEA/H/C/005367 - PSUSA/00010969/202202

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Product information documents contain:

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])

Assessment history

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