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ONDANSETRON ACCORD 2MG/ML
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1472835
Name of medicinal product:
ONDANSETRON ACCORD 2MG/ML
Active substances:
Ondansetron
Estonian
,
English
,
Latin
ATC code:
A04AA01
Dosage form:
solution for injection/infusion
Route of administration:
intravenous use
Strengh:
2mg 1ml
Amount in package:
2ml 5TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Adults: Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, Prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population: Management of chemotherapy-induced nausea and vomiting in children aged >=6 months. Prevention and treatment of post-operative nausea and vomiting in children aged >= 1 month.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated October 3, 2022)
Package information leaflet (PIL):
EST
(last updated October 3, 2022)
Labelling:
(last updated March 19, 2019)
Last imported to Estonia:
June 13, 2019
Marketing authorization
Marketing authorization holder:
Accord Healthcare B.V.
Marketing authorization number:
679810
Marketing authorization issued on:
April 21, 2010
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: March 12, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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