Myocet

RSS

doxorubicin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Myocet. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myocet.

This EPAR was last updated on 20/08/2018

Authorisation details

Product details
Name
Myocet
Agency product number
EMEA/H/C/000297
Active substance
doxorubicin hydrochloride
International non-proprietary name (INN) or common name
doxorubicin
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01DB01
Publication details
Marketing-authorisation holder
Teva B.V.
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
12/07/2000
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

19/07/2018 Myocet - EMEA/H/C/000297 - IA/0057/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Myocet, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

Assessment history

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