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PALONOSETRON KALCEKS
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1830675
Name of medicinal product:
PALONOSETRON KALCEKS
Active substances:
Palonosetron
Estonian
,
English
,
Latin
ATC code:
A04AA05
Dosage form:
solution for injection
Route of administration:
intravenous use
Strengh:
50mcg 1ml
Amount in package:
5ml 1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Palonosetron Kalceks is indicated in adults for: ? the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; ? the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Kalceks is indicated in paediatric patients 1 month of age and older for: ? the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated March 6, 2023)
Package information leaflet (PIL):
EST
(last updated May 23, 2022)
Labelling:
(last updated May 23, 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Kalceks AS
Marketing authorization number:
1045621
Marketing authorization issued on:
November 3, 2021
Marketing authorization expires on:
November 3, 2026
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: October 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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