Carmustine Obvius

carmustine

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An overview of Carmustine Obvius and why it is authorised in the EU

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.

How is Carmustine Obvius used?

Carmustine Obvius is given by infusion (drip) into a vein. It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription. A dose based on the patient’s weight and height is given at intervals of at least 6 weeks, and should be adjusted according to the patient’s blood cell counts.

For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist.

How does Carmustine Obvius work?

Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent. It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply. Because cancer cells tend to grow and multiply more than normal cells they are more vulnerable to the action of the medicine. By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading.

How has Carmustine Obvius been studied?

Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.

As for every medicine, the company provided studies on the quality of Carmustine Obvius. There was no need for ‘bioequivalence’ studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Carmustine Obvius?

Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Carmustine Obvius authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris. Therefore, the Agency’s view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Carmustine Obvius?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Carmustine Obvius are continuously monitored. Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.

Other information about Carmustine Obvius

Information on the reference medicine can also be found on the Agency’s website.

Name Language First published Last updated
Carmustine Obvius : EPAR - Medicine overview BG = bălgarski 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview ES = español 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview CS = čeština 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview DA = dansk 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview DE = Deutsch 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview ET = eesti keel 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview EL = elliniká 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview EN = English 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview FR = français 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview IT = italiano 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview LV = latviešu valoda 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview LT = lietuvių kalba 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview HU = magyar 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview MT = Malti 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview NL = Nederlands 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview PL = polski 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview PT = português 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview RO = română 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview SK = slovenčina 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview SL = slovenščina 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview FI = suomi 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview SV = svenska 2018-08-20  
Carmustine Obvius : EPAR - Medicine overview HR = Hrvatski 2018-08-20  

This EPAR was last updated on 20/08/2018 .

Authorisation details

Product details

Product details for Carmustine Obvius
NameCarmustine Obvius
Agency product numberEMEA/H/C/004326
Active substance

carmustine

International non-proprietary name (INN) or common name

carmustine

Therapeutic area Multiple MyelomaHodgkin DiseaseLymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code L01AD01
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Carmustine Obvius
Marketing-authorisation holder

Obvius Investment B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union19/07/2018

Contact address:

Obvius Investment B.V.
De Cuserstraat 93
1081 CN Amsterdam
Netherlands

Product information

Product information

19/07/2018  Carmustine Obvius -EMEA/H/C/004326

Name Language First published Last updated
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - Product Information HR = Hrvatski 2018-08-20  

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.


Name Language First published Last updated
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  
Carmustine Obvius : EPAR - All Authorised presentations HR = Hrvatski 2018-08-20  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Carmustine Obvius : EPAR - Public assessment report HR = Hrvatski 2018-08-20  
CHMP summary of positive opinion for Carmustine Obvius HR = Hrvatski 2018-04-27  

Authorised

This medicine is approved for use in the European Union