Somavert

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pegvisomant

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

Overview

Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.

Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).

Somavert contains the active substance pegvisomant.

This EPAR was last updated on 16/04/2019

Authorisation details

Product details
Name
Somavert
Agency product number
EMEA/H/C/000409
Active substance
Pegvisomant
International non-proprietary name (INN) or common name
pegvisomant
Therapeutic area (MeSH)
Acromegaly
Anatomical therapeutic chemical (ATC) code
H01AX01
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
Pfizer Europe MA EEIG
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
12/11/2002
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

04/03/2019 Somavert - EMEA/H/C/000409 - IB/0090

Contents

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Pharmacotherapeutic group

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Therapeutic indication

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF -I concentrations or was not tolerated.

Assessment history

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