Product class:
|
Authorized package
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Medicinal product class:
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For human use
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Package code:
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1709793
|
Name of medicinal product:
|
SOMAVERT
|
Active substances:
|
|
ATC code:
|
H01AX01
|
Dosage form:
|
powder and solvent for solution for injection
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
30mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
lahusti 1 ml
|
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.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
19 March 2024
|
Marketing authorization holder:
|
Pfizer Europe MA EEIG
|
Marketing authorization number:
|
EU/1/02/240
|
Marketing authorization issued on:
|
17 July 2015
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
13 September 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription