Somavert
pegvisomant
Table of contents
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.
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
27
|
Date of issue of marketing authorisation valid throughout the European Union |
12/11/2002
|
Contact address |
Boulevard de la Plaine 17 |
Product information
29/09/2022 Somavert - EMEA/H/C/000409 - N/0105
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
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.