Carmustine Obvius

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carmustine

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

Overview

Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:

  • brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
  • Hodgkin’s lymphoma and non-Hodgkin’s lymphomas, types of cancer that originate from white blood cells. The medicine is used when initial treatment has not worked or the cancer has come back.

Carmustine Obvius is a ‘generic medicine’. This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Carmubris.

This EPAR was last updated on 12/11/2018

Authorisation details

Product details
Name
Carmustine Obvius
Agency product number
EMEA/H/C/004326
Active substance
carmustine
International non-proprietary name (INN) or common name
carmustine
Therapeutic area (MeSH)
  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code
L01AD01
GenericGeneric

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
Obvius Investment B.V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/07/2018
Contact address
De Cuserstraat 93
1081 CN Amsterdam
Netherlands

Product information

09/11/2018 Carmustine Obvius - EMEA/H/C/004326 - IB/0001

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):

• Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases

• Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease

Assessment history

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