Palonosetron Hospira
palonosetron
Table of contents
Overview
The marketing authorisation of Palonosetron Hospira has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Palonosetron Hospira
|
| Agency product number |
EMEA/H/C/004069
|
| Active substance |
palonosetron hydrochloride
|
| International non-proprietary name (INN) or common name |
palonosetron
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
A04AA05
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
08/04/2016
|
| Contact address |
Boulevard de la Plaine 17 |
Product information
12/12/2018 Palonosetron Hospira - EMEA/H/C/004069 - IAIN/0005/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antiemetics and antinauseants
Therapeutic indication
Palonosetron Hospira 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 Hospira 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.