Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1205345
|
Name of medicinal product:
|
EMEND
|
Active substances:
|
|
ATC code:
|
A04AD12
|
Dosage form:
|
capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
125mg/80mg
|
Amount in package:
|
125mg 1TK / 80mg 2TK
|
Legal status for supply*:
|
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 125 mg/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:
|
August 11, 2021
|
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
You can download Acrobat Reader fromhere