Cetrotide

cetrorelix

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This is a summary of the European public assessment report (EPAR) for Cetrotide. 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 Cetrotide.

What is Cetrotide?

Cetrotide is a medicine that contains the active substance cetrorelix. It is available as a powder and solvent used to make a solution for injection.

What is Cetrotide used for?

Cetrotide is used to prevent premature ovulation (early release of eggs from the ovary). It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).

The medicine can only be obtained with a prescription.

How is Cetrotide used?

Treatment with Cetrotide should be carried out by a doctor who has experience in this type of fertility treatment. Cetrotide is given by injection under the skin of the lower abdomen (belly). The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening. Treatment starts on day 5 or 6 of ovarian stimulation, and is continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.

Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes. Further injections may be given by the patient herself, as long as she is made aware of the signs of allergic reaction and what to do if they appear. The medicine should be injected slowly at different places on the abdomen every day.

How does Cetrotide work?

The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing hormone (LHRH) in the body. LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation. During fertility treatment, ovarian stimulation is used to make the ovaries produce more eggs. By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).

How has Cetrotide been studied?

The ability of Cetrotide to prevent premature ovulation has been studied in three main studies involving 814 women. Cetrotide was compared with buserelin nasal spray and triptorelin depot injection. These medicines act on the secretion of LH, but work by overstimulating the production of LHRH so that the body stops making LH. The main measure of effectiveness was the prevention of premature LH production.

What benefit has Cetrotide shown during the studies?

Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH. Between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin. Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.

What is the risk associated with Cetrotide?

The most common side effects with Cetrotide (seen in between 1 and 10 patients in 100) are mild to moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation procedure itself) and reactions at the injection site, such as redness, swelling and itching. For the full list of all side effects reported with Cetrotide, see the package leaflet.

Cetrotide must not be used in people who are hypersensitive (allergic) to cetrorelix or any of the other ingredients, to any hormones that are chemically similar to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone medicines similar to Cetrotide). It must not be used in women who are pregnant or breastfeeding, or in patients with severe kidney disease. For the full list of restrictions, see the package leaflet.

Why has Cetrotide been approved?

The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the prevention of premature ovulation. The CHMP decided that Cetrotide’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

Other information about Cetrotide

The European Commission granted a marketing authorisation valid throughout the European Union for Cetrotide on 13 April 1999.

For more information about treatment with Cetrotide, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Cetrotide : EPAR - Summary for the public BG = bălgarski 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public ES = español 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public CS = čeština 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public DA = dansk 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public DE = Deutsch 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public ET = eesti keel 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public EL = elliniká 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public EN = English 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public FR = français 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public IT = italiano 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public LV = latviešu valoda 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public LT = lietuvių kalba 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public HU = magyar 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public MT = Malti 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public NL = Nederlands 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public PL = polski 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public PT = português 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public RO = română 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public SK = slovenčina 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public SL = slovenščina 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public FI = suomi 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public SV = svenska 2009-11-24 2016-06-28
Cetrotide : EPAR - Summary for the public HR = Hrvatski 2009-11-24 2016-06-28

This EPAR was last updated on 13/09/2017 .

Authorisation details

Product details

Product details for Cetrotide
NameCetrotide
Agency product numberEMEA/H/C/000233
Active substance

cetrorelix

International non-proprietary name (INN) or common name

cetrorelix

Therapeutic area Ovulation InductionOvulation
Anatomical therapeutic chemical (ATC) code H01CC02

Publication details

Publication details for Cetrotide
Marketing-authorisation holder

Merck Serono Europe Ltd.

Revision21
Date of issue of marketing authorisation valid throughout the European Union13/04/1999

Contact address:

Merck Serono Europe Ltd.
56, Marsh Wall
London
E14 9TP
United Kingdom

Product information

Product information

26/07/2017  Cetrotide -EMEA/H/C/000233 -IB/0060

Name Language First published Last updated
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13
Cetrotide : EPAR - Product Information HR = Hrvatski 2009-10-16 2017-09-13

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
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06
Cetrotide : EPAR - All Authorised presentations HR = Hrvatski 2007-10-11 2014-10-06

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.

In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Cetrotide : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Cetrotide : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21  

Authorised

This medicine is approved for use in the European Union