Neuraceq

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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Neuraceq 300 MBq/mL solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of 
calibration. 
The activity per vial ranges from 300 MBq to 3000 MBq at the date and time of calibration. 
 
Fluorine (18F) decays to stable oxygen (18O) with a half-life of approximately 110 minutes by emitting 
a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV. 
 
Excipient(s) with known effect 
This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see 
section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1  Therapeutic indications 
 
This medicinal product is for diagnostic use only.  
 
Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of 
β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are 
being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq 
should be used in conjunction with a clinical evaluation.  
 
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For 
the limitations in the interpretation of a positive scan see sections 4.4 and 5.1. 
 
4.2 Posology and method of administration 
 
A PET scan with florbetaben (18F) should be requested by clinicians experienced in the clinical 
management of neurodegenerative disorders. 
 
Neuraceq images should only be interpreted by readers trained in the interpretation of PET images 
with florbetaben (18F). A recent co-registered computed tomography (CT) scan or magnetic resonance 
(MR) imaging of the patient to get a fused PET-CT or PET-MR image is recommended in cases of 
uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see 
section 4.4).  
 
Posology 



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The recommended activity for an adult is 300 MBq florbetaben (18F). The maximum dose should not 
exceed 360 MBq and not fall below 240 MBq at time of administration. The volume of Neuraceq to 
be injected can be from 0.5 to 10 mL in order to provide the target activity of 300 MBq at the time of 
intravenous administration. 
 
Special populations 
 
Elderly  
No dose adjustment is recommended based on age. 
 
Renal and hepatic impairment 
Careful consideration of the activity to be administered is required since an increased radiation 
exposure is possible in these patients (see section 4.4). 
 
Extensive dose-range and adjustment studies with the medicinal product in normal and special 
populations have not been performed. The pharmacokinetics of florbetaben (18F) in patients with renal 
or hepatic impairment has not been characterised.  
 
Paediatric population 
There is no relevant use of Neuraceq in the paediatric population. 
 
Method of administration 
Neuraceq is for intravenous use and for multidose use.  
 
The activity of florbetaben (18F) has to be measured with an activimeter (dose calibrator) immediately 
prior to injection.  
 
Neuraceq should not be diluted. 
 
The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of 
approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full 
delivery of the dose. If the injection volume ranges between 0.5 and 1 mL, only syringes of an 
appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride 
solution (see section 12).  
 
The injection of florbetaben (18F) must be intravenous in order to avoid irradiation as a result of local 
extravasation, as well as imaging artefacts. 
 
Image acquisition 
A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous 
injection of florbetaben (18F).  
 
Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the 
PET scanner field of view. Reducing head movement with tape or other flexible head restraints may 
be employed. Reconstruction should include attenuation correction with resulting transaxial pixel 
sizes between 2.0 and 3.0 mm. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
 
4.4 Special warnings and precautions for use 
 
Individual benefit/risk justification 



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For each patient, the radiation exposure must be justified by the likely benefit. The activity 
administered should, in every case, be as low as reasonably achievable to obtain the required 
diagnostic information. 
 
Renal impairment and hepatic impairment 
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation 
exposure is possible. Florbetaben (18F) is excreted primarily through the hepatobiliary system and 
patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2). 
 
Paediatric population 
For information on the use in the paediatric population, see sections 4.2 or 5.1. 
 
Interpretation of Neuraceq images 
Neuraceq images should only be interpreted by readers trained in the interpretation of PET images 
with florbetaben (18F). A negative scan indicates sparse or no density of cortical β-amyloid plaques. A 
positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of 
brain β-amyloid neuritic plaque density, including false negatives and false positives, have been 
observed. 
 
PET images are read in a transaxial orientation using a grey scale. The reader should compare the 
cortical grey matter signal intensity to the maximum white matter signal intensity. The images should 
be viewed in a systematic manner (Figure 1) starting at the level of cerebellum and scrolling up 
through the lateral temporal and frontal lobes, then to the area of the posterior cingulate cortex and 
precuneus, and finally to the parietal lobe.  
 
Interpretation of the images is made visually comparing the activity in cortical grey matter with 
activity in adjacent cortical white matter. Each of these brain regions, the lateral temporal, frontal, 
posterior cingulate, precuneus, and parietal lobes should be systematically visually assessed and 
scored according to the regional cortical tracer uptake (RCTU) score (Table 1).  
 
Table 1: Definitions of regional cortical tracer uptake (RCTU) 
 
RCTU score Condition for assessment 

1 (No tracer uptake) 
Tracer uptake (i.e., signal intensity) in grey matter in the 
region is lower than in white matter. 

2 (Moderate tracer uptake) 

Smaller area(s) of tracer uptake equal to or higher than 
that present in white matter: extending beyond the white 
matter rim to the outer cortical margin involving the 
majority of the slices within the respective region. 

3 (Pronounced tracer uptake) 

A large confluent area of tracer uptake equal to or higher 
than that present in white matter extending beyond the 
white matter rim to the outer cortical margin and 
involving the entire region including the majority of slices 
within the respective region. 

Note: For a score of tracer uptake in the cortex, the finding should have been present in the majority of 
the slices within the region in question. 
 
 
 
 
 
 
 
 



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Figure 1: Neuraceq PET cases showing examples of negative florbetaben (18F) PET scan (top 
row) and positive scan (bottom row).  
 

 
 
The overall decision of the visual PET scan assessment is subject-based and based on a binary 
outcome as ‘positive’ or ‘negative‘. A subject is classified as “positive” or “negative” based on the 
brain amyloid plaque load (BAPL) score (Table 2) which is derived from RCTU scores in the four 
brain regions (Table 1). 
 
Table 2: Definitions of brain amyloid plaque load (BAPL) 
 
Assessment BAPL score Rule for assessment 

Negative scan 

1 Scan without beta-amyloid 
deposition 

RCTU score 1 in each of the  4 brain 
regions (lateral temporal lobes, frontal 
lobes, posterior cingulate/precuneus, 
parietal lobes) 

Positive scan 

2 Scan with moderate 
beta-amyloid deposition  

RCTU score 2 in any or all of the 
4 brain regions and no score 3 in these 
4 brain regions 

3 Scan with pronounced 
beta-amyloid deposition 

RCTU score 3 at least in one of 4 brain 
regions  

 
Limitations of use 
A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since 
neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some 
neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia).  
 
For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.  
 
The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy 
has not been established (see section 5.1). 
 
Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or 
image blurs, which could lead to interpretation errors. For cases in which there is uncertainty about 
the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered 



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recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR 
image to clarify the relationship of the PET radioactivity and the grey matter anatomy. 
 
Increased uptake has been identified in extracerebral structures such as face, scalp and bone in some 
cases. Residual activity in the midsagittal sinus can be sometimes observed (see section 5.2).  
 
After the procedure 
Close contact with infants and pregnant women should be restricted during the initial 24 hours 
following the injection. 
 
Specific warnings 
This medicinal product contains up to 33 mg sodium per dose, equivalent to 1.6% of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 
This medicinal product contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 
30 mL beer or 12.5 mL wine per dose.  
 
Harmful for those suffering from alcoholism. 
 
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as 
patients with liver disease, or epilepsy. 
 
For precautions with respect to environmental hazard, see section 6.6. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No in vivo interaction studies have been performed. 
 
In radioligand binding assays using a broad panel of animal and human receptors, ion channels and 
transporters no significant binding was found. 
 
In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome 
P450 enzyme system. 

 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential  
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it 
is important to determine whether or not she is pregnant. Any woman who has missed a period should 
be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the 
woman has missed a period, if the period is very irregular, etc.), alternative techniques not using 
ionising radiation (if there are any) should be offered to the patient.  
 
Pregnancy 
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. 
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit 
far exceeds the risk incurred by the mother and foetus. 
No studies have been conducted in pregnant women. No animal studies have been conducted to 
investigate the reproductive effects in florbetaben (18F) (see section 5.3). 
 
Breast-feeding 
It is unknown whether florbetaben (18F) is excreted in human milk. Before administering 
radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the 
possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, 
and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of 



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activity in breast milk. If the administration is considered necessary, breast-feeding should be 
interrupted for 24 hours and the expressed feeds discarded. 
 
Close contact with infants should be restricted during the initial 24 hours following injection. 
 
Fertility 
No fertility studies have been performed.  
 
4.7 Effects on ability to drive and use machines 
 
Neuraceq has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 
1,077 subjects and 12 subjects who received vehicle. Repeat dosing in yearly intervals showed that 
there was no difference in safety profile after first, second or third dosing. 
 
Tabulated list of adverse reactions 
The adverse reactions are ranked under heading of frequency using the following convention: very 
common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); 
rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the 
available data). Within each frequency grouping, adverse reactions are presented in order of 
decreasing seriousness.  
 
Table 3: List of adverse reactions 
System Organ Class Common Uncommon 

Nervous  system disorders  Neuralgia 
Headache 
Burning sensation 
Tremor 

Vascular disorders  Hypotension 
Flushing 
Haematoma 

Gastrointestinal disorders  Diarrhoea 
Nausea 

Hepatobiliary disorders  Hepatic function abnormal 

Skin and subcutaneous tissue disorders  Toxic skin eruption 
Rash 
Hyperhidrosis 

Musculoskeletal and connective tissue 
disorders 

 Pain in extremity 
Limb discomfort 



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General disorders and administration 
site conditions 

Injection site pain 
Injection/application site 
erythema 

Pyrexia 
Fatigue 
Feeling hot 
Vessel puncture site pain 
Catheter site pain 
Injection site haematoma 
Injection site irritation 
Puncture site reaction 
Injection site discomfort 
Injection site warmth 

Investigations   Blood creatinine increased  

 
Exposure to ionising radiation is linked with cancer induction and a potential for development of 
hereditary defects. As the effective dose is about 5.8 mSv when the maximum recommended activity 
of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a 
low probability. 
 
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Due to the small quantity of florbetaben (18F) in each dose, overdose is not expected to result in 
pharmacological effects. In the event of administration of a radiation overdose, the absorbed dose to 
the patient should be reduced where possible by increasing the elimination of the radionuclide from 
the body by frequent micturition and defecation. It might be helpful to estimate the effective dose that 
was applied. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, central nervous system; 
ATC code: V09AX06  
 
Mechanism of action 
Florbetaben (18F) binds to β-amyloid neuritic plaques in the brain. In vitro, florbetaben (18F) shows 
nanomolar binding affinity to synthetic β-amyloid fibrils and to AD brain homogenate. In addition, 
binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated 
by autoradiography and supported by immunohistochemistry or Bielschowsky stain.  
In vivo, quantitative correlation was not assessed in end-of-life patients between florbetaben (18F) 
uptake in cortical grey matter and the beta-amyloid deposition in autopsied samples. The in vivo 
binding of florbetaben (18F) to other amyloid structures or other brain structures or receptors remains 
unknown.  
 
Pharmacodynamic effects  
At the low chemical concentrations present in Neuraceq, florbetaben (18F) does not have any 
detectable pharmacodynamic activity. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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In completed clinical trials, uptake of florbetaben (18F) in 7 predefined cortical areas of the brain 
(frontal, parietal, lateral and medial temporal, occipital, caudate, posterior cingulate/precuneus cortex, 
and anterior cingulate gyrus) and cerebellar cortex was measured quantitatively using standardised 
uptake values (SUV). Cortical SUV ratios (SUVRs, relative to cerebellar cortex) are higher in AD 
patients compared with those of healthy volunteer subjects. 
 
Clinical efficacy 
A pivotal study in 31 end-of-life patients was aimed at establishing the diagnostic performance of 
florbetaben (18F) to detect the cortical neuritic plaque density (no or sparse vs. moderate or frequent) 
as established by the CERAD criteria. The PET results were compared with the maximal neuritic 
plaque density measured on sections of middle frontal gyrus, superior and middle temporal gyri, 
inferior parietal lobe, hippocampus and other brain regions at the patient’s autopsy. The cognitive 
status of the subjects could not be determined reliably. In all 31 subjects, a blinded visual 
subject-level PET reading by 3 blinded readers resulted in a majority read sensitivity of 
100% (95% CI: 80.5-100%) and specificity 85.7% (95% CI: 67.4 - 100%). In a post-hoc analysis 
sensitivity and specificity of the majority read of the visual subject-level PET reading vs 
histopathology in a larger population (74 patients) was 97.9% (95% CI: 93.8 - 100%) and 
88.9% (95% CI: 77-100%). 
Sensitivity and specificity to estimate beta-amyloid deposition of florbetaben (18F) was further 
investigated in one additional study, in which a different set of 5 electronically-trained blinded readers 
interpreted images from 54 subjects followed to autopsy in the pivotal study. The histopathology 
criteria did not match the CERAD criteria. The results were lower than the results obtained in the 
pivotal trial: a sensitivity range between 77.5% to 90% and specificity range between 62.5-85.7%. 
Inter-rater agreement using Fleiss’ kappa values ranged from 0.68 to 0.87. Comparing the results of 
PET scan reading with the histopathology assessment collected for all subjects (same as used for the 
original pivotal study and its post-hoc analysis), the majority read sensitivity and specificity were 
100% (95%CI: 89.4-100%) and 71.4% (95%CI: 52.1-90.8%), respectively. 
 
In a longitudinal study, 45 subjects clinically diagnosed with mild cognitive impairment (MCI), 
underwent baseline florbetaben (18F) PET scans, and were followed for 24 months to evaluate the 
relationship between florbetaben (18F) imaging and changes in diagnostic status. 29 (64.4%) of MCI 
patients were positive by florbetaben (18F) PET scan. At the 24-month follow-up, 19 (42.2%) 
converted to clinical AD. Of the 29 MCI subjects who had a positive PET scan, 19 (65.5%) were 
classified clinically as converted to clinical AD after 24 months compared to 0 (0%) of 16 who had a 
negative scan. Sensitivity of florbetaben (18F) scan to show the MCI conversion rate to AD in 
19 converters was 100%, specificity in 26 non-converters was 61.5% (95% CI: 42.8-80.2%) and 
positive likelihood ratio was 2.60 (1.60-4.23). The design of this study does not allow estimating the 
risk of MCI progression to clinical AD. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
florbetaben (18F) in all subsets of the paediatric population as the disease or condition for which the 
specific medicinal product is intended only occurs in adult population, and the specific medicinal 
product does not represent a significant therapeutic benefit over existing treatments for paediatric 
patients (see section 4.2 for information on paediatric use).  
 
5.2 Pharmacokinetic properties 
 
Distribution  
After intravenous bolus injection a radioactivity concentration of 2-3% injected dose/L is achieved in 
arterial plasma 10 minutes after injection. 
 
Florbetaben (18F) is highly bound to plasma proteins (>98.5%).  
 
Organ uptake 



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Uptake of radioactivity in the brain is rapid, reaching about 6% of injected radioactivity at 10 minutes 
post injection. 
 
Healthy controls show relatively low levels of florbetaben (18F) retention in cortex. The highest level 
of uptake is in pons and other white matter regions. In AD subjects, cortical regions and striatal 
regions show significantly greater uptake compared to controls. In AD subjects, as in controls, there is 
high retention in pons and other white matter areas.  
 
Uptake has also been identified in some cases in extracerebral structures such as face, scalp and bone. 
The reason for this accumulation is unknown, but maybe due to accumulation of florbetaben (18F) or 
to any of its radioactive metabolites, or to blood radioactivity. Residual activity in the midsagittal 
sinus can be sometimes observed likely due to the presence of tracer in the blood pool.  
 
The biophysical basis of the white matter retention of florbetaben (18F) in the living human brain 
cannot be definitively explained. It is hypothesised that unspecific binding of the radiopharmaceutical 
to the lipid-containing myelin sheath may contribute to white matter retention. 
 
Elimination 
Florbetaben (18F) is eliminated from plasma of AD patients with a mean biological half-life of 
about 1 hour. No radioactivity could be measured in blood at about 4 hours post injection.  
Based on in vitro investigations florbetaben (18F) is metabolised predominantly 
by CYP2J2 and CYP4F2.  
 
At 12 hours post-injection, up to approximately 30% of the injected radioactivity is excreted with 
urine. Time points beyond that time frame did not allow for further quantitation of activity in urine. 
 
Half-life 
Fluorine (18F) has a physical half-life of 110 minutes.  
At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the 
activity is decayed. 
 
Renal/hepatic impairment 
The pharmacokinetics in patients with renal or hepatic impairment has not been characterised. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, single and repeated dose toxicity and genotoxicity. The potential toxicity of 28 days of 
repeated intravenous injections of florbetaben (18F) was tested in rats and dogs, and the NOAEL was 
found to be at least 20 times the maximum human dose. 
 
Chronic studies and carcinogenicity studies have not been carried out, since the medicinal product is 
not intended for regular or continuous administration.  
 
Studies on reproduction toxicity have not been performed.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Ascorbic acid 
Ethanol anhydrous 
Macrogol 400  
Sodium ascorbate (for pH adjustment)  
Water for injections 



11 
 

 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other 
medicinal products. 
 
6.3 Shelf life 
 
Up to 10 hours from the end of the synthesis. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive 
materials. 
 
6.5 Nature and contents of container  
 
Colourless 15 mL Type I glass vial, sealed with a chlorobutyl stopper and aluminium seal. 
 
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq at the date 
and time of calibration (ToC). 
 
As a result of differences in the manufacturing process, it is possible that some vials are distributed 
with punctured rubber stoppers. 
 
Pack size: one vial 
 
6.6 Special precautions for disposal and other handling 
 
General warning 
Radiopharmaceuticals should be received, used and administered only by authorised persons in 
designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the 
regulations and/or appropriate licences of the competent official organisation.  
 
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and 
pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. 
 
If the integrity of the vial is compromised it should not be used. 
 
Administration procedures should be carried out in a way to minimise risk of contamination of the 
medicinal product and irradiation of the operators. Adequate shielding is mandatory. 
 
The administration of radiopharmaceuticals creates risks for other persons (including pregnant 
healthcare professionals) from external radiation or contamination from spill of urine, vomiting, etc. 
Radiation protection precautions in accordance with national regulations must therefore be taken. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
 
 
 
 
 



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7. MARKETING AUTHORISATION HOLDER 
 
Life Radiopharma Berlin GmbH 
Max-Planck-Straße 4 
12489 Berlin 
Germany 
e-mail: gra@life-mi.com  
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/906/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20. February 2014 
Date of latest renewal: 20. November 2018 
 



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10. DATE OF REVISION OF THE TEXT 
 
 
11.  DOSIMETRY  
 
The table below shows the dosimetry as calculated using the OLINDA (Organ Level INternal Dose 
Assessment) software. 
 
The estimated absorbed radiation doses to organs are listed in Table 3, providing data from Caucasian 
healthy volunteers (n=17). Dosimetry calculations were adapted to the adult model (with a body 
weight of 70 kg).  
 
Table 4: Estimated radiation absorbed doses from intravenous injection of Neuraceq to 
Caucasian subjects 
 

Organ  Dose absorbed per activity administered [mGy/MBq] 
Adrenal 0.0130  
Brain  0.0125  
Breasts 0.0074  
Gallbladder  0.137  
Gastrointestinal tract 

Lower large intestine  0.0351  
Small intestine  0.0314  
Stomach 0.0116  
Upper large intestine 0.0382  

Heart  0.0139  
Kidneys  0.0238  
Liver  0.0386  
Lungs  0.0148  
Muscles 0.00948  
Ovaries  0.0156 
Pancreas  0.0139  
Red marrow  0.0122  
Osteogenic cells  0.0148  
Skin  0.00689  
Spleen  0.0102  
Testes  0.00913  
Thymus  0.00892  
Thyroid  0.00842 
Bladder 0.0695  
Uterus  0.0163  
Remaining organs  0.0110  
Effective dose (mSv/MBq) 0.0193 

 
The effective dose resulting from the administration of a maximal recommended activity of 360 MBq 
dose for an adult weighing 70 kg is about 7.0 mSv. If a CT scan is simultaneously performed as part 
of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the 
settings used in the CT acquisition. For an administered activity of 360 MBq the typical radiation 
dose to the target organ (brain) is 4.5 mGy. 
 
For an administered activity of 360 MBq the typical radiation doses delivered to the critical organs, 
gallbladder, urinary bladder, upper large intestine wall, lower large intestine wall, small intestine and 
liver are 49.3 mGy, 25.0 mGy, 13.8 mGy, 12.6 mGy, 11.3 mGy and 13.9 mGy, respectively. 



14 
 

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS 
 
Method of preparation 
The package must be checked before use and the activity measured using an activimeter. 
 
Withdrawals should be performed under aseptic conditions. The vials must not be opened before 
disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe 
fitted with suitable protective shielding and a disposable sterile needle or using an authorised 
automated application system. If the integrity of the vial is compromised, the medicinal product 
should not be used. 
 
Florbetaben (18F) should not be diluted. 
 
The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of 
approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full 
delivery of the dose. If the injection volume ranges between 0.5 and 1 mL, only syringes of an 
appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride 
solution.  
 
The injection of florbetaben (18F) must be intravenous in order to avoid irradiation as a result of local 
extravasation, as well as imaging artefacts. 
 
Quality control 
The solution should be inspected visually prior to use. Only clear solutions, free of visible particles 
should be used. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



16 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Alliance Medical Radiopharmacy Ltd.  
Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU  
United Kingdom 
 
BC Cyclotron VU  
De Boelelaan 1081 
1081 HV Amsterdam 
The Netherlands 
 
Cis Bio International  
CHU de Brabois 
Avenue de Bourgogne  
54500 Vandoeuvre les Nancy  
France  
 
Cis Bio International  
Parc scientifique Georges Besse 
180 Allée Von Neumann 
30000 Nîmes 
France 
 
Cis Bio International  
14 rue de la Grange aux Belles 
75010 Paris 
France 
 
Cis Bio International  
Centre Eugene Marquis  
Rue de la Bataille Flandres Dunkerque, CS 44229 
35042 Rennes 
France 
 
Cis Bio International  
Hôpital Xavier Arnozan 
Avenue du Haut Lévèque 
33600 Pessac (Bordeaux) 
France 
 
Life Radiopharma Berlin GmbH  
Max-Planck-Strasse 4 
12489 Berlin 
Germany 
 
Advanced Accelerator Applications Germany GmbH  
Marchioninistrasse 15 
81377 Munich  
Germany 



17 
 

 
Life Radiopharma Warszawa Sp. z o.o.  
ul. Szeligowska 3  
05-850 Szeligi 
Poland 
 
Life Radiopharma GmbH  
Spessartstr. 9  
53119 Bonn 
Germany 
 
IBA Molecular Italy S.R.L.  
via Pergolesi, 33 
20052 Monza 
Italy  
 
IBA Molecular Italy S.R.L.  
Viale Oxford 81 (Tor Vergata) 
00133 Rome 
Italy 
 
IBA Molecular Italy S.R.L.  
Piazzale Santa Maria della Misericordia, 15 



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33100 Udine 
Italy 
 
Curium Pharma Spain, S.A.  
Thomas Alba Edison, s/n 
41092 Seville 
Spain 
 
Curium Pharma Spain, S.A.  
Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16,  
Ajalvir 28864 (Madrid)  
Spain 
 
Seibersdorf Labor GMBH  
Grundstueck Nr. 482/2 EZ 98 KG 
2444 Seibersdorf 
Austria 
 
BetaPlus Pharma SA  
Avenue Hippocrate 10 bte 1527 
1200 Brussels  
Belgium 
 
Institut Radiofarmacia Aplicada Barcelona-IRAB 
c/Doctor Aiguader 88, planta -1 
08003 Barcelona 
Spain 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirement for submission of periodic safety update report for this medicinal product are set 
out in the line of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2011/83/EC and any subsequent updates published on the European medicines web-portal.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 



19 
 

 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency;  
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
• Additional risk minimisation measures  
 
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final 
educational programme with the National Competent Authority.  
 
The MAH shall ensure that, following discussion and agreement with the National Competent 
Authority in each Member State where Neuraceq is marketed, at launch and after launch, all 
physicians who are expected to use Neuraceq have access to a training programme in order to ensure 
accurate and reliable interpretation of the PET images. 
 
The training programme should contain the following key elements: 
• Information on amyloid pathology in Alzheimer’s disease; 
• Relevant information on Neuraceq as anβ-amyloid PET tracer, including the approved 

indication according to the SmPC, limitations of Neuraceq use, interpretation errors, safety 
information and the results of clinical trials informing on the diagnostic use of Neuraceq; 

• Review of the PET reading criteria, including method of image review, criteria for 
interpretation, and images demonstrating the read methodology; 

• The training material should include Neuraceq PET demonstration cases with correct PET scan 
interpretation by an experienced reader Neuraceq-PET scans for self-assessment and a self-
qualification procedure to be offered to each trainee. Training should include a sufficient 
number of clearly positive and negative cases as well as intermediate level cases. Cases should 
be histopathologically confirmed, if possible. 

• Expertise and qualification of trainers should be ensured. 



20 
 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



21 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 



22 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
METALLIC BOX (with Blue Box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neuraceq 300 MBq/mL solution for injection 
florbetaben (18F)  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of 
calibration. 
 
 
3. LIST OF EXCIPIENTS 
 
Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate (for pH adjustment), water for 
injections 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Customer ref 
 
Activity: {XXX} MBq in {XX} mL 
 
ToC: {DDMMYYYY} {XX}h{XX} {Time zone} 
 
Volume: {XX} mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use.  
Multidose.  
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 

 Radioactive material. 



23 
 

 
Alliance Medical Radiopharmacy Ltd., UK 
 
BV Cyclotron VU, the Netherlands 
 
Cis Bio International, Nancy, France 
 
Cis Bio International, Nîmes, France 
 
Cis Bio International, Paris, France 
 
Cis Bio International, Rennes, France 
 
Cis Bio International, Pessac, France 

 
Life Radiopharma Berlin GmbH, Germany 
 
Advanced Accelerator Applications Germany GmbH, Germany 
 
Life Radiopharma Warszawa Sp. z o.o., Poland 
 
Life Radiopharma Bonn GmbH, Germany  
 
IBA Molecular Italy S.R.L., Monza, Italy 
 
IBA Molecular Italy S.R.L., Rome, Italy 
 
IBA Molecular Italy S.R.L., Udine, Italy 
 
Curium Pharma Spain, S.A., Seville, Spain 
 
Curium Pharma Spain, S.A., Madrid, Spain 
 
Seibersdorf Labor GmbH, Austria  
 
BetaPlus Pharma SA, Brussels, Belgium 
 
Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain 
 
 
8. EXPIRY DATE 
 
EXP {DD/MM/YYYY} {XX}h{XX} {Time zone} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused material should be disposed of in accordance with national regulations.  
 
 



24 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Life Radiopharma Berlin GmbH, Max-Planck-Straße 4, 12489 Berlin, DE 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/906/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
<Justification for not including Braille accepted> 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<Not applicable> 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
<Not applicable> 



25 
 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LEAD POT (without Blue Box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Neuraceq 300 MBq/mL solution for injection 
florbetaben (18F)  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of 
calibration. 
 
 
3. LIST OF EXCIPIENTS 
 
Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections. 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
One multi-dose vial 
 
Activity: {XXX} MBq in {XX} mL 
 
ToC: {DDMMYYYY} {XX}h{XX} {Time zone} 
 
Volume: {XX} mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use.  
Multidose. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 

 Radioactive material. 
 



26 
 

Alliance Medical Radiopharmacy Ltd., UK 
 
BV Cyclotron VU, the Netherlands 
 
Cis Bio International, Nancy, France 
 
Cis Bio International, Nîmes, France 
 
Cis Bio International, Paris, France 
 
Cis Bio International, Rennes, France 
 
Cis Bio International, Pessac, France  

 
Life Radiopharma Berlin GmbH, Germany 
 
Advanced Accelerator Applications Germany GmbH, Germany  
 
Life RadiopharmaWarszawa Sp. z o.o., Poland 
 
Life Radiopharma Bonn GmbH, Germany   
 
IBA Molecular Italy S.R.L., Monza, Italy 
 
IBA Molecular Italy S.R.L., Rome, Italy 
 
IBA Molecular Italy S.R.L., Udine, Italy 
 
Curium Pharma Spain, S.A., Seville, Spain 
 
Curium Pharma Spain, S.A., Madrid, Spain 
 
Seibersdorf Labor GmbH, Austria 
 
BetaPlus Pharma SA, Brussels, Belgium 
 
Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain 
 
 
8. EXPIRY DATE 
 
EXP {DD/MM/YYYY} {XX}h{XX} {Time zone} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package to protect from ionizing radiation (lead shielding). 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused medicinal product or waste should be disposed of in accordance with local requirements. 
 



27 
 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Life Radiopharma Berlin GmbH, Max-Planck-Straße 4, 12489 Berlin, DE  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/906/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
<Justification for not including Braille accepted> 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<Not applicable> 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
<Not applicable> 



28 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Neuraceq 300 MBq/mL solution for injection 
florbetaben (18F)  
Intravenous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: ToC + 6 h 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Act.: ≤ 3000 MBq at ToC (see outer label)  
 
 
6. OTHER 
 

 Radioactive material. 
 
Alliance Medical Radiopharmacy Ltd., UK 
 
BV Cyclotron VU, the Netherlands 
 
Cis Bio International, Nancy, France 
 
Cis Bio International, Nîmes, France 
 
Cis Bio International, Paris, France 
 
Cis Bio International, Rennes, France 
 
Cis Bio International, Pessac, France  

 
Life Radiopharma Berlin GmbH, Germany 
 
Advanced Accelerator Applications Germany GmbH, Germany  
 
Life RadiopharmaWarszawa Sp. z o.o., Poland 



29 
 

Life Radiopharma Bonn GmbH, Germany   
 
IBA Molecular Italy S.R.L., Monza, Italy 
 
IBA Molecular Italy S.R.L., Rome, Italy 
 
IBA Molecular Italy S.R.L., Udine, Italy 
 
Curium Pharma Spain, S.A., Seville, Spain 
 
Curium Pharma Spain, S.A., Madrid, Spain 
 
Seibersdorf Labor GmbH, Austria 
 
BetaPlus Pharma SA, Brussels, Belgium 
 
Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain 



30 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 



31 
 

Package leaflet: Information for the patient 
 

Neuraceq 300 MBq/mL solution for injection 
florbetaben (18F) 

 
Read all of this leaflet carefully before you are given this medicine because it contains 
important information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your nuclear medicine doctor who will supervise the 

procedure.  
- If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side 

effects not listed in this leaflet. See section 4.  
 

What is in this leaflet: 
 
1. What Neuraceq is and what it is used for 
2. What you need to know before Neuraceq is used 
3. How Neuraceq will be used 
4. Possible side effects 
5. How Neuraceq is stored 
6. Contents of the pack and other information 
 
 
1.  What Neuraceq is and what it is used for 
 
This medicine is a radiopharmaceutical product for diagnostic use only. 
 
Neuraceq contains the active substance florbetaben (18F).  
 
Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, 
called a PET scan. A Neuraceq PET scan, along with other brain function tests, can help your doctor 
determine whether or not you may have β-amyloid plaques in your brain. This medicine is intended 
for adults only.  
 
You should discuss the results of the test with the doctor that requested the scan. 
 
The use of Neuraceq does involve exposure to small amounts of radioactivity. Your doctor and the 
nuclear medicine doctor have considered that the clinical benefit of this procedure with the 
radiopharmaceutical outweighs the risk of being exposed to radiation. 
 
 
2.  What you need to know before Neuraceq is used 
 
Neuraceq must not be used: 
- if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in 

section 6).  
 

Warnings and precautions 
Talk to your nuclear medicine doctor before you are given Neuraceq if you: 
- have kidney problems 
- have liver problems 
- are pregnant or think you may be pregnant  
- are breast-feeding 
 
Children and adolescents 



32 
 

Neuraceq is not intended for use in children and adolescents below the age of 18 years old. 
 
Other medicines and Neuraceq 
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other 
medicines since they may interfere with the interpretation of the images from the PET scan. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your nuclear medicine doctor for advise before you are given this medicine. 
 
You must inform the nuclear medicine doctor before you are given Neuraceq if there is a possibility 
you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it 
is important to consult your nuclear medicine doctor who will supervise the procedure.  
 
Pregnant 
The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected 
which would outweigh the risks.  
 
Breast-feeding 
You must stop breast-feeding for 24 hours after the injection. Express breast milk during this period 
and discard the breast milk you have expressed. Resuming breast-feeding should be in agreement with 
the nuclear medicine doctor who will supervise the procedure.  
 
Driving and using machines 
Neuraceq has no influence on the ability to drive and use machines. 
 
Neuraceq contains ethanol and sodium ascorbate 
- This medicine contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 

30 mL beer or 12.5 mL wine per dose.  
Harmful for those suffering from alcoholism, and is also to be taken into account in pregnant or 
breast-feeding women, children and high-risk groups such as patients with liver disease, or 
epilepsy. 

- This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each 
dose. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium 
for an adult. 
 

3.  How Neuraceq will be used 
 
There are strict laws on the use, handling and disposal of radiopharmaceutical products.  
Neuraceq will only be used in specially controlled areas. This medicine will only be handled and 
given to you by professionals who are trained and qualified to use it safely. These persons will take 
special care for the safe use of this medicine and will keep you informed of their actions. 
 
 
Dose 
The nuclear medicine doctor supervising the procedure will decide on the amount of Neuraceq to be 
used in your case. It will be the smallest amount necessary to get the desired information. 
 
The quantity to be administered usually recommended for an adult is 300 MBq (megabecquerel, the 
unit used to express radioactivity). 
 
Administration of Neuraceq and conduct of the procedure 
Neuraceq is given as an injection into your vein (intravenous injection) followed by a flush of sodium 
chloride solution to ensure full delivery of the dose.  
 
One injection is sufficient to carry out the scan that your doctor needs. 



33 
 

 
Duration of the procedure 
A brain scan is usually taken 90 minutes after Neuraceq is given.  
Your nuclear medicine doctor will inform you about the usual duration of the procedure.  
 
After administration of Neuraceq, you should: 
Avoid any close contact with young children and pregnant women for 24 hours following the 
injection. 
 
The nuclear medicine doctor will inform you if you need to take any special precautions after 
receiving this medicine. Contact your nuclear medicine doctor if you have any questions. 
 
If you have been given more Neuraceq than you should 
An overdose is unlikely since you will only receive a single dose of Neuraceq precisely controlled by 
the nuclear medicine doctor supervising the procedure.  
 
However, in the case of an overdose, you will receive the appropriate treatment. In particular, the 
nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine 
and stools in order to help remove radioactivity from your body. 
 
If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor 
who supervises the procedure. 
 
 
4.  Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Possible side effects include: 
 
Common (may affect up to 1 in 10 people): 
- Injection site reactions: injection site pain, redness of the skin at injection site (injection / 

application site erythema) 
 

Uncommon (may affect up to 1 in 100 people): 
- Burning sensation, headache, neuralgia (intense, typically intermittent pain along the course of 

a nerve), tremor (an involuntary quivering movement) 
- Vessels: flushing (sudden reddening of the face and/or neck), haematoma (a bruise, a black and 

blue mark), hypotension (low blood pressure) 
- Stomach: diarrhea, nausea (feeling sick) 
- Liver: abnormal liver function 
- Skin: hyperhidrosis (excessive sweat), rash, toxic skin eruption (acute skin affections with 

measles-type erythema of the skin, potentially including blisters and ulcerations) 
- Muscles and bones: limb discomfort, pain in extremity 
- Injection site conditions: injection site irritation, pain and discomfort around the injection site, 

injection site haematoma (a bruise, a black and blue mark at injection site), injection site 
warmth, tiredness, feeling hot, pyrexia (raised body temperature, a fever) 

- Abnormal blood test: increased blood creatinine levels (reduced kidney function) 
 
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk 
of cancer and hereditary abnormalities.  
 
Reporting of side effects 
If you get any side effects please talk to your nuclear medicine doctor. This includes any side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 



34 
 

listed in Appendix V. By reporting side effects, you can help provide more information on the safety 
of this medicine. 
 
 
5.  How Neuraceq is stored 
 
You will not have to store this medicine. This medicine is stored under the responsibility of the 
specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with 
national regulation on radioactive materials. 
 
The following information is intended for the specialist only: 
- Keep out of the sight and reach of children. 
- Do not use after the expiry date which is stated on the box, shield label and vial label after 

EXP. 
- This medicine does not require any special storage conditions.  
- Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 
 
 

6.  Contents of the pack and other information 
 
What Neuraceq contains 
- The active substance is florbetaben (18F). Each mL of solution for injection contains 300 MBq 

of florbetaben (18F) at the date and time of calibration. The activity per vial ranges from 300 
MBq to 3000 MBq at the date and time of calibration. 

- The other ingredients are ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, 
and water for injections (see section 2 “Neuraceq contains ethanol and sodium ascorbate”). 

 
What Neuraceq looks like and contents of the pack 
Neuraceq is a clear, colourless solution for injection. It is supplied in a colourless 15 mL glass vial, 
sealed with a rubber stopper and aluminium seal. 
 
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq of 
florbetaben (18F) at the date and time of calibration. 
 
Pack size of 1 vial.  
 
Marketing Authorization Holder  
Life Radiopharma Berlin GmbH 
Max-Planck-Straße 4 
12489 Berlin 
Germany 
e-mail: gra@life-mi.com 
 
Manufacturer  
Alliance Medical Radiopharmacy Ltd.  
Unit 19, Quadrum Park, Old Portsmouth Road  
Peasmarsh, Guildford, Surrey, GU3 1LU 
United Kingdom 
 
BV Cyclotron VU 
De Boelelaan 1081 
1081 HV Amsterdam 
The Netherlands  
 
Cis Bio International  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


35 
 

CHU de Brabois 
Avenue de Bourgogne  
54500 Vandoeuvre les Nancy  
France  
 
Cis Bio International 
Parc scientifique Georges Besse 
180 Allée Von Neumann 
30000 Nîmes 
France 
 
Cis Bio International  
14, rue de la Grange aux Belles 
75010 Paris 
France 
 
Cis Bio International 
Centre Eugene Marquis  
Rue de la Bataille Flandres Dunkerque, CS 44229 
35042 Rennes 
France 
 
Cis Bio International 
Hôpital Xavier Arnozan 
Avenue du Haut Lévèque 
33600 Pessac (Bordeaux) 
France 
 
Life Radiopharma Berlin GmbH 
Max-Planck-Strasse 4 
12489 Berlin 
Germany 
 
Advanced Accelerator Applications Germany GmbH 
Marchioninistrasse 15 
81377 Munich 
Germany 



36 
 

 
Life RadiopharmaWarszawa Sp. z o.o. 
ul. Szeligowska 3  
05-850 Szeligi 
Poland 
 
Life Radiopharma Bonn GmbH  
Spessartstr. 9  
53119 Bonn 
Germany 
 
IBA Molecular Italy S.R.L. 
via Pergolesi, 33 
20052 Monza 
Italy 
 
IBA Molecular Italy S.R.L. 
Viale Oxford 81 (Tor Vergata) 
00133 Rome 
Italy 
 
IBA Molecular Italy S.R.L. 
Piazzale Santa Maria della Misericordia, 15 
33100 Udine 
Italy 
 
Curium Pharma Spain, S.A. 
Thomas Alba Edison, s/n 
41092 Seville 
Spain 
 
Curium Pharma Spain, S.A. 
Pol. Ind. Conpisa,  
C/ Veguillas – 2 Nave 16,  
Ajalvir 28864 (Madrid) 
Spain 
 
Seibersdorf Labor GmbH 
Grundstueck Nr. 482/2 EZ 98 KG 
2444 Seibersdorf 
Austria 
 
BetaPlus Pharma SA 
Avenue Hippocrate 10 bte 1527 
1200 Brussels  
Belgium 
 
Institut Radiofarmacia Aplicada Barcelona-IRAB 
c/Doctor Aiguader 88, planta -1 
08003 Barcelona 
Spain 
 
For any information about this medicine, please contact the Marketing Authorisation Holder. 
 
This leaflet was last revised in {month YYYY}. 
 



37 
 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  
 
 
The following information is intended for medical or healthcare professionals only. 
 
The complete SmPC of Neuraceq is provided as a separate document in the product package, with the 
objective to provide healthcare professionals with other additional scientific and practical information 
about the administration and use of this radiopharmaceutical. 
 
Please refer to the SmPC {SmPC should be included in the box}. 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET