Somavert (pegvisomant)
- Region
- 🇪🇺 EU
- Active substance
- pegvisomant
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Acromegaly
- CHMP opinion
- Thu 25 Jul 2002
- EU approval
- Tue 12 Nov 2002
- Application
- EMEA/H/C/000409
- ATC
- H01AX01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.