Striascan

Authorised

This medicine is authorised for use in the European Union

ioflupane (123l)

Overview

Striascan is a diagnostic medicine. It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.

The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):

• movement disorders such as those in Parkinson’s disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles. Because tremor can also occur in ‘essential tremor’ (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson’s disease;
• dementia (loss of intellectual function). Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies’ and Alzheimer’s disease.

Striascan contains the active substance ioflupane (123I) and is a ‘generic medicine’. This means that Striascan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called DaTSCAN.

How is Striascan used?

Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia. Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.

Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein. A scan is taken 3 to 6 hours after the injection. Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland. 

Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.

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

How does Striascan work?

The active substance in Striascan, ioflupane (123I), is a radiopharmaceutical. It contains a substance called ioflupane, which is labelled with 123I (iodine 123), a radioactive form of iodine. Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.

When Striascan is injected, ioflupane (123I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine. This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine 123.

In patients with Parkinson’s disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum. If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan. This enables diseases related to Parkinson’s disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer’s disease.

How has Striascan been studied?

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

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

What are the benefits and risks of Striascan?

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

Why is Striascan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN. Therefore, the Agency’s view was that, as for DaTSCAN, the benefit of Striascan 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 Striascan?

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

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

Other information about Striascan

Striascan received a marketing authorisation valid throughout the EU on 25 June 2019.

Striascan : EPAR - Medicine overview

Reference Number: EMA/410451/2019

Striascan : EPAR - Risk Management Plan

Product information

Striascan : EPAR - Product information

Latest procedure affecting product information: IB/0009

11/04/2024

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Striascan : EPAR - All authorised presentations

Product details

• Name of medicine:
  Striascan
• Active substance:
  ioflupane (123l)
• International non-proprietary name (INN) or common name:
  ioflupane (123l)
• Therapeutic area (MeSH):
  • Radionuclide Imaging
  • Dementia
  • Movement Disorders
• Anatomical therapeutic chemical (ATC) code:
  V09AB03

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

This medicinal product is for diagnostic use only.

Striascan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

• In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Striascan is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.
• In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

Authorisation details

• EMA product number:
  EMEA/H/C/004745
• Generic:

  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.

• Marketing authorisation holder:
  CIS bio international

  Route Nationale 306, Saclay; B.P. 32; F-91192 Gif sur Yvette Cedex; France

• Opinion adopted:
  25/06/2019
• Marketing authorisation issued:
  25/06/2019
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Striascan : EPAR - Procedural steps taken and scientific information after the authorisation

Initial marketing authorisation documents

Striascan : EPAR - Public assessment report

AdoptedReference Number: EMA/280752/2019

CHMP summary of positive opinion for Striascan

AdoptedReference Number: EMA/CHMP/225317/2019