About
This is a summary of the European public assessment report (EPAR) for Yttriga. 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 Yttriga.
- What is Yttriga?
Yttriga is a radioactive liquid, which contains the active substance yttrium (90Y) chloride. 90Y, or yttrium-90, is a radioactive form of the chemical element yttrium.
- What is Yttriga used for?
Yttriga is not used on its own but is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled (tagged) with a radioactive compound. Once the substance is labelled with Yttriga, it then carries the radioactivity to where it is needed in the body, for example the site of a tumour.
Yttriga is used to label medicines that have been specially developed for use with yttrium (90Y) chloride.
The medicine can only be obtained with a prescription.
- How is Yttriga used?
Yttriga is only to be used by specialists who have experience in radiolabelling.
Yttriga is never given directly to a patient. Radiolabelling of a medicine takes place outside the body in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine’s summary of product characteristics (SmPC).- How does Yttriga work?
The active substance in Yttriga, yttrium (90Y) chloride, is a radioactive compound that emits a type of radiation known as beta radiation. The effect of Yttriga depends on the nature of the medicine that is radiolabelled with it. An example of its use is the treatment of some type of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour to destroy the tumour cells.
- How has Yttriga been studied?
As Yttriga will only be used to prepare radiolabelled medicines, no studies of Yttriga have been done in humans. The company presented information from scientific articles already published on 90Y. The company also presented published information on the effect of using 90Y to radiolabel other medicines, including one study of non-Hodgkin’s lymphoma (a cancer of the lymph tissue, part of the immune system).
- What benefit has Yttriga shown during the studies?
The information supplied by the company shows the utility of Yttriga as a precursor to radiolabel medicines with 90Y.
- What is the risk associated with Yttriga?
Yttriga is a precursor and will not be given on its own. The side effects seen with treatment involving Yttriga will therefore depend largely on the medicine being labelled and will be described in that medicine’s package leaflet. Yttriga itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects. The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
Yttriga must not be given directly to any patient. Medicines radiolabelled with Yttriga should not be used in people who may be hypersensitive (allergic) to yttrium chloride or any of the other ingredients. A medicine labelled with Yttriga must not be used in women who are or may be pregnant. More information on the restrictions on the use of medicines radiolabelled with Yttriga will be found in their package leaflets.- Why has Yttriga been approved?
The CHMP decided that Yttriga’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about Yttriga
The European Commission granted a marketing authorisation valid throughout the European Union for Yttriga on 19 January 2006.
For more information about treatment with Yttriga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
| Name | Language | First published | Last updated |
|---|---|---|---|
| Yttriga : EPAR - Summary for the public | BG = bălgarski | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | ES = español | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | CS = čeština | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | DA = dansk | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | DE = Deutsch | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | ET = eesti keel | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | EL = elliniká | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | EN = English | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | FR = français | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | IT = italiano | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | LV = latviešu valoda | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | LT = lietuvių kalba | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | HU = magyar | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | MT = Malti | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | NL = Nederlands | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | PL = polski | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | PT = português | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | RO = română | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | SK = slovenčina | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | SL = slovenščina | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | FI = suomi | 07/08/2007 | 12/09/2011 |
| Yttriga : EPAR - Summary for the public | SV = svenska | 07/08/2007 | 12/09/2011 |
This EPAR was last updated on 06/12/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
21/11/2011 Yttriga -EMEA/H/C/000596 -N/0009
| Name | Language | First published | Last updated |
|---|---|---|---|
| Yttriga : EPAR - Product Information | BG = bălgarski | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | ES = español | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | CS = čeština | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | DA = dansk | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | DE = Deutsch | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | ET = eesti keel | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | EL = elliniká | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | EN = English | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | FR = français | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | IT = italiano | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | LV = latviešu valoda | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | LT = lietuvių kalba | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | HU = magyar | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | MT = Malti | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | NL = Nederlands | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | PL = polski | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | PT = português | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | RO = română | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | SK = slovenčina | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | SL = slovenščina | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | FI = suomi | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | SV = svenska | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | IS = Islenska | 19/08/2009 | 06/12/2011 |
| Yttriga : EPAR - Product Information | NO = Norsk | 19/08/2009 | 06/12/2011 |
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
Diagnostic radiopharmaceuticals
Therapeutic indication
To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Radiopharmaceutical precursor - Not intended for direct use in patients.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Yttriga : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 19/08/2009 | 06/12/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Yttriga : EPAR - Scientific Discussion | (English only) | 29/10/2006 | |
| Yttriga : EPAR - Procedural steps taken before authorisation | (English only) | 29/10/2006 |
Authorised
This medicine is approved for use in the European Union
Yttriga RSS feed