Product class:
|
Authorized package
|
Medicinal product class:
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For human use
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Package code:
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1203286
|
Name of medicinal product:
|
EMEND
|
Active substances:
|
|
ATC code:
|
A04AD12
|
Dosage form:
|
capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
80mg
|
Amount in package:
|
2TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Prevention of nausea and vomiting associated with highly and moderately emetogenic
cancer chemotherapy in adults and adolescents from the age of 12.
EMEND 80 mg is given as part of combination therapy (see section 4.2).
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
July 11, 2007
|
Marketing authorization holder:
|
Merck Sharp & Dohme B.V.
|
Marketing authorization number:
|
EU/1/03/262
|
Marketing authorization issued on:
|
November 11, 2003
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
June 4, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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