Cerdelga

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1.  NAME OF THE MEDICINAL PRODUCT 
 
Cerdelga 84 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each capsule contains 84.4 mg of eliglustat (as tartrate). 
 
Excipient(s) with known effect:  
Each capsule contains 106 mg lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule 
 
Capsule with pearl blue-green opaque cap and pearl white opaque body with “GZ02” printed in black 
on the body of the capsule. The size of the capsule is ‘size 2’ (dimensions 18.0 x 6.4 mm). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), 
who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers 
(EMs). 
 
4.2 Posology and method of administration  
 
Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the 
management of Gaucher disease. 
 
Posology   
 
The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) 
and extensive metabolisers (EMs). The recommended dose is 84 mg eliglustat once daily in CYP2D6 
poor metabolisers (PMs).  
 
Missed dose 
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose 
should not be doubled. 
 
Special populations 
 
CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers 
Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or 
indeterminate metabolisers (see section 4.4). 



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Patients with hepatic impairment 
In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, 
eliglustat is contraindicated (see sections 4.3 and 5.2). 
 
In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), 
eliglustat is not recommended (see sections 4.4 and 5.2). 

In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment (Child-Pugh class A), no 
dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily.  
 
In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic 
impairment, eliglustat is not recommended (see sections 4.4 and 5.2). 

In CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong 
or moderate CYP2D6 inhibitor, Cerdelga is contraindicated (see sections 4.3 and 5.2).  
 
In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 
inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should 
be considered (see sections 4.4 and 5.2). 
 
Patients with renal impairment 
In CYP2D6 extensive metabolisers (EMs) with mild, moderate or severe renal impairment, no dosage 
adjustment is required and the recommended dose is 84 mg eliglustat twice daily (see sections 4.4 
and 5.2). 
 
In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 
and 5.2).     
 
In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate or 
severe renal impairment or ESRD, eliglustat is not recommended (see sections 4.4 and 5.2). 
 
Elderly  
There is limited experience in the treatment of elderly with eliglustat. Data indicates that no dosage 
adjustment is considered necessary (see sections 5.1 and 5.2). 
  
Paediatric population 
The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been 
established. No data are available.  
 
Method of administration 
 
Cerdelga is to be taken orally. The capsules should be swallowed whole, preferably with water, and 
should not be crushed, dissolved, or opened.  
 
The capsules may be taken with or without food. Consumption of grapefruit or its juice should be 
avoided (see section 4.5). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a 
strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and 
patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor. Use of Cerdelga 
under these conditions results in substantially elevated eliglustat plasma concentrations (see 
section 4.4 and 4.5). 



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Due to significantly increased eliglustat plasma concentrations, Cerdelga is contraindicated in 
CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 extensive 
metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 
inhibitor (see sections 4.2 and 5.2). 
 
4.4 Special warnings and precautions for use 
 
Initiation of therapy: CYP2D6 genotyping 
 
Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine 
the CYP2D6 metaboliser status (see section 4.2, Special populations). 
 
Drug-drug interactions 
 
Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive 
metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong  or 
moderate CYP3A inhibitor, and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong 
CYP3A inhibitor (see section 4.3).  
 
For use of eliglustat with one strong or moderate inhibitor of CYP2D6 or CYP3A, see section 4.5. 
 
Use of eliglustat with strong CYP3A inducers substantially decreases the exposure to eliglustat, which 
may reduce the therapeutic effectiveness of eliglustat; therefore concomitant administration is not 
recommended (see section 4.5). 
 
Patients with pre-existing cardiac conditions 
 
Use of eliglustat in patients with pre-existing cardiac conditions has not been studied during clinical 
trials. Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated 
plasma concentrations, use of eliglustat should be avoided in patients with cardiac disease (congestive 
heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), 
long QT syndrome, and in combination with Class IA (e.g. quinidine) and Class III (e.g. amiodarone, 
sotalol) antiarrhythmic medicinal products. 
 
Patients with hepatic impairment 
 
Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic 
impairment. Use of eliglustat in these patients is not recommended (see sections 4.2. and 5.2). 

Limited or no data are available in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers 
(PMs) with any degree of hepatic impairment. Use of eliglustat in these patients is not recommended 
(see sections 4.2 and 5.2). 

Concomitant use of eliglustat with CYP2D6 or CYP3A4 inhibitors in CYP2D6 extensive metabolisers 
(EMs) with mild hepatic impairment can result in further elevation of eliglustat plasma concentrations, 
with the magnitude of the effect depending on the enzyme inhibited and the potency of the inhibitor. 
In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 
inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of  84 mg eliglustat mg once daily 
should be considered (see sections 4.2 and 5.2). 
 
Patients with renal impairment 
   
Limited or no data are available in CYP2D6 extensive metabolisers (EMs), intermediate metabolisers 
(IMs) or poor metabolisers (PMs)  with ESRD and in CYP2D6 intermediate metabolisers (IMs) or 
poor metabolisers (PMs) with mild, moderate, or severe renal impairment; use of eliglustat in these 
patients is not recommended (see sections 4.2 and 5.2). 



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Monitoring of clinical response 
 
Some treatment-naïve patients showed less than 20% spleen volume reduction (sub-optimal results) 
after 9 months of treatment (see section 5.1). For these patients, monitoring for further improvement or 
an alternative treatment modality should be considered. 
 
For patients with stable disease who switch from enzyme replacement therapy to eliglustat, monitoring 
for disease progression (e.g. after 6 months with regular monitoring thereafter) should be performed 
for all disease domains to evaluate disease stability. Reinstitution of enzyme replacement therapy or an 
alternative treatment modality should be considered in individual patients who have a sub-optimal 
response. 
 
Lactose 
 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or 
glucose-galactose malabsorption should not take this medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Eliglustat is metabolised primarily by CYP2D6 and to a lesser extent by CYP3A4. Concomitant 
administration of substances affecting CYP2D6 or CYP3A4 activity may alter eliglustat plasma 
concentrations. Eliglustat is an inhibitor of P-gp and CYP2D6 in vitro; concomitant administration of 
eliglustat with P-gp or CYP2D6 substrate substances may increase the plasma concentration of those 
substances. 
 
The list of substances in section 4.5 is not an inclusive list and the prescriber is advised to consult the 
SmPC of all other prescribed medicinal products for potential drug-drug interactions with eliglustat. 
 
Agents that may increase eliglustat exposure 
 
Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive 
metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or 
moderate CYP3A inhibitor , and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong 
CYP3A inhibitor (see section 4.3). Use of Cerdelga under these conditions results in substantially 
elevated eliglustat plasma concentrations.  
 
CYP2D6 inhibitors 
In intermediate (IMs) and extensive metabolisers (EMs): 
 
After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with 
repeated 30 mg once daily doses of paroxetine, a strong inhibitor of CYP2D6, resulted in a 7.3- and 
8.9-fold increase in eliglustat Cmax and AUC0-12, respectively. A dose of eliglustat 84 mg once daily 
should be considered when a strong CYP2D6 inhibitor (e.g. paroxetine, fluoxetine, quinidine, 
bupropion) is used concomitantly in IMs and EMs. 
 
At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of 
moderate CYP2D6 inhibitors (e.g. duloxetine, terbinafine, moclobemide, mirabegron, cinacalcet, 
dronedarone) would increase eliglustat exposure approximately up to 4-fold. Caution should be used 
with moderate CYP2D6 inhibitors in IMs and EMs. 
 
In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and 
4.4.  
In extensive metabolisers (EMs) with severe hepatic impairment: see sections 4.2 and 4.3. 
CYP3A inhibitors 
 



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In intermediate (IMs) and extensive metabolisers (EMs): 
 
After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with 
repeated 400 mg once daily doses of ketoconazole, a strong inhibitor of CYP3A, resulted in a 3.8 and 
4.3-fold increase in eliglustat Cmax and AUC0-12, respectively; similar effects would be expected for 
other strong inhibitors of CYP3A (e.g. clarithromycin, ketoconazole, itraconazole, cobicistat, 
indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, 
telithromycin, conivaptan, boceprevir). Caution should be used with strong CYP3A inhibitors in IMs 
and EMs. 
 
At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of 
moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, 
aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase eliglustat 
exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in IMs 
and EMs. 
 
In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.  
 
In extensive metabolisers (EMs) with moderate or severe hepatic impairment: see sections 4.2 and 4.3. 
 
In poor metabolisers (PMs): 
 
At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of strong 
CYP3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, 
ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, 
boceprevir) would increase the Cmax and AUC0-24 of eliglustat 4.3- and 6.2-fold. The use of strong 
CYP3A inhibitors is contraindicated in PMs. 
 
At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of moderate 
CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, 
atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase the Cmax and AUC0-24 of 
eliglustat 2.4- and 3.0-fold, respectively. Use of a moderate CYP3A inhibitor with eliglustat is not 
recommended in PMs. 
 
Caution should be used with weak CYP3A inhibitors (e.g. amlodipine, cilostazol, fluvoxamine, 
goldenseal, isoniazid, ranitidine, ranolazine) in PMs. 
 
CYP2D6 inhibitors used simultaneously with CYP3A inhibitors 
In intermediate (IMs) and extensive metabolisers (EMs): 
 
At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that the concomitant use of 
strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors would increase Cmax 
and AUC0-12 up to 17- and 25-fold, respectively. The use of a strong or moderate CYP2D6 inhibitor 
concomitantly with a strong or moderate CYP3A inhibitor is contraindicated in IMs and EMs. 
 
Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma 
concentrations of eliglustat. Consumption of grapefruit or its juice should be avoided. 
 
Agents that may decrease eliglustat exposure 
 
Strong CYP3A inducers 
After repeated 127 mg twice daily doses of eliglustat in non-PMs, concomitant administration of 
repeated 600 mg once daily doses of rifampicin (a strong inducer of CYP3A as well as the efflux 
transporter P-gp) resulted in an approximately 85% decrease in eliglustat exposure. After repeated 
84 mg twice daily doses of eliglustat in PMs, concomitant administration of repeated 600 mg once 
daily doses of rifampicin resulted in an approximately 95% decrease in eliglustat exposure. Use of a 



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strong CYP3A inducer (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, rifabutin and St. 
John’s wort) with eliglustat is not recommended in IMs, EMs and PMs. 
 
Agents whose exposure may be increased by eliglustat 
 
P-gp substrates 
After a single 0.25 mg dose of digoxin, a P-gp substrate, concomitant administration of 127 mg twice 
daily doses of eliglustat resulted in a 1.7- and 1.5-fold increase in digoxin Cmax and AUClast, 
respectively. Lower doses of substances which are P-gp substrates (e.g. digoxin, colchicine, 
dabigatran, phenytoin, pravastatin) may be required. 
 
CYP2D6 substrates 
After a single 50 mg dose of metoprolol, a CYP2D6 substrate, concomitant administration of repeated 
127 mg twice daily doses of eliglustat resulted in a 1.5- and 2.1-fold increase in metoprolol Cmax and 
AUC, respectively. Lower doses of medicinal products that are CYP2D6 substrates may be required. 
These include certain antidepressants (tricyclic antidepressants, e.g. nortriptyline, amitriptyline, 
imipramine, and desipramine), phenothiazines, dextromethorphan and atomoxetine). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of eliglustat in pregnant women. Animal studies 
do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.  
 
Breast-feeding 
 
It is unknown whether eliglustat or its metabolites are excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of eliglustat in milk (see section 
5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to 
discontinue breast-feeding or to discontinue/abstain from Cerdelga therapy taking into account the 
benefit of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Effects on testes and reversible inhibition of spermatogenesis were observed in rats (see section 5.3). 
The relevance of these findings for humans is not known. 
 
4.7 Effects on ability to drive and use machines 
 
Cerdelga has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The overall adverse reaction profile of Cerdelga is based on 1400 patient-years of treatment exposure 
and pooled results from the primary analysis periods and extension periods of two pivotal Phase 3 
studies (ENGAGE and ENCORE), one 8-year, long term Phase 2 study (Study 304) and one 
supporting Phase 3b study (EDGE). In these four studies a total of 393 patients between the ages of 
16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years). 
 
The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the 
clinical trial patients.  
 



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Tabulated list of adverse reactions 
 
Adverse reactions are ranked by system organ class and frequency ([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)]). Adverse reactions from long term clinical trial data reported in at least 4 patients are 
presented in Table 1.Within each frequency grouping, adverse reactions are presented in order of 
decreasing seriousness. 
 
Table 1: Tabulated list of adverse reactions 

System Organ Class Common 

Nervous system disorders Headache*, dizziness*, dysgeusia 
Cardiac disorders Palpitations 
Respiratory, thoracic and mediastinal disorders Throat irritation 

Gastrointestinal disorders 

Dyspepsia, abdominal pain upper*, 
diarrhoea*, nausea, constipation, abdominal 
pain*, gastrooesophageal reflux disease, 
abdominal distension*, gastritis, dysphagia, 
vomiting*, dry mouth, flatulence  

Skin and subcutaneous tissue disorders Dry skin, urticaria*  
Musculoskeletal and connective tissue disorders Arthralgia, pain in extremity*, back pain*  
General disorders and administration site conditions Fatigue 

 
* The incidence of the adverse reaction was the same or higher with placebo than with Cerdelga in the 

placebo-controlled pivotal study. 
 
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 
 
The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose 
escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times 
the recommended dose for GD1 patients. At the time of the highest plasma concentration (59-fold 
higher than normal therapeutic conditions), the subject experienced dizziness marked by 
disequilibrium, hypotension, bradycardia, nausea, and vomiting. 
  
In the event of acute overdose, the patient should be carefully observed and given symptomatic 
treatment and supportive care. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract 
and metabolism products, ATC code: A16AX10. 
 

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


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Mechanism of action 
 
Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate 
reduction therapy (SRT) for GD1. SRT aims to reduce the rate of synthesis of the major substrate 
glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby 
preventing glucosylceramide accumulation and alleviating clinical manifestations. 
 
Pharmacodynamic effects 
 
In clinical trials in treatment-naïve GD1 patients, plasma GL-1 levels were elevated in the majority of 
these patients and decreased upon Cerdelga treatment. Additionally, in a clinical trial in GD1 patients 
stabilised on enzyme replacement therapy (ERT) (i.e. having already achieved therapeutic goals on 
ERT prior to initiating Cerdelga treatment), plasma GL-1 levels were normal in most patients and 
decreased upon Cerdelga treatment. 
 
Clinical efficacy and safety 
 
The recommended dosing regimens (see section 4.2) are based on modelling, either of PK/PD data 
from the dose-titration regimens applied in the clinical studies for IMs and EMs, or physiologically-
based PK data for PMs. 
 
Pivotal study of Cerdelga in treatment-naïve GD1 patients – study 02507(ENGAGE) 
Study 02507 was a randomized, double-blind, placebo-controlled, multicenter clinical study in 
40 patients with GD1. In the Cerdelga group 3 (15%) patients received a starting dose of 42 mg 
eliglustat twice daily during the 9-month primary analysis period and 17 (85%) patients received a 
dose escalation to 84 mg twice daily based on plasma trough concentration. 
 
Table 2: Change from baseline to Month 9 (primary analysis period) in treatment-naïve patients 

with GD1 receiving treatment with Cerdelga in study 02507  

 
Placebo* 
(n=20) a 

Cerdelga 
(n=20) a 

Difference 
(Cerdelga – 
Placebo) 
[95% CI] 

p valueb 

Percentage Change in Spleen Volume MN (%) 
(primary endpoint) 2.26 -27.77 

-30.0 
[-36.8, -23.2] <0.0001 

Absolute Change in Haemoglobin Level (g/dL) 
(secondary endpoint) -0.54

  0.69 1.22 [0.57, 1.88] 0.0006 

Percentage Change in Liver Volume MN (%) 
(secondary endpoint) 1.44

  -5.20 -6.64 [-11.37, -1.91] 0.0072 

Percentage Change in Platelet Count (%) 
(secondary endpoint) -9.06

  32.00 41.06 [23.95, 58.17] <0.0001 

MN = Multiples of Normal, CI = confidence interval 
a At baseline, mean spleen volumes were 12.5 and 13.9 MN in the placebo and Cerdelga groups, 

respectively, and mean liver volumes were 1.4 MN for both groups.  Mean haemoglobin levels 
were 12.8 and 12.1 g/dL, and platelet counts were 78.5 and 75.1 x 109/L, respectively. 

b Estimates and p-values are based on an ANCOVA model 
* All patients transitioned to Cerdelga treatment after Month 9.   

 
During the open-label long term treatment period with Cerdelga (extension phase), all patients with 
complete data who continued to receive Cerdelga showed further improvements throughout the 
extension phase. Results (change from baseline) after 18 months, 30 months and 4.5 years of exposure 
to Cerdelga on the following endpoints were: absolute change in haemoglobin level (g/dL) 1.1 (1.03) 
[n=39], 1.4 (0.93) [n=35], and 1.4 (1.31) [n=12]; mean increase in platelet count (mm3) 58. 5% 
(40.57%) [n=39], 74.6% (49.57%) [n=35], and 86.8% (54.20%) [n=12]; mean reduction in spleen 
volume (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], and 65.6% (7.43%) [n=13]; and mean 



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reduction in liver volume (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], and 23.4% 
(10.59%) [n=13].  
 
Long-term clinical outcomes in treatment-naïve GD1 patients – study 304 
Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients. Nineteen 
patients completed 4 years of treatment. Fifteen (79%) of these patients received a dose escalation to 
84 mg eliglustat twice daily; 4 (21%) patients continued to receive 42 mg twice daily.   

Eighteen patients completed 8 years of treatment. One patient (6%) received a further dose escalation 
to 127 mg twice daily. Fourteen (78%) continued on 84 mg Cerdelga twice daily. Three (17%) patients 
continued to receive 42 mg twice daily. Sixteen patients had an efficacy endpoint assessment at year 8. 

Cerdelga showed sustained improvements in organ volume and haematological parameters over the 8 
year treatment period (see Table 3). 
 
Table 3: Change from baseline to year 8 in study 304  

 N Baseline Value 
(Mean) 

Change from 
Baseline (Mean) 
 

Standard Deviation 

Spleen Volume (MN) 15 17.34 -67.9%  17.11 
Haemoglobin Level (g/dL) 16 11.33 2.08 1.75 
Liver Volume (MN) 15 1.60 -31.0%  13.51 
Platelet Count (x109/L) 16 67.53  109.8%  114.73 

MN = Multiples of Normal 
 
Pivotal study of Cerdelga in GD1 patients switching from ERT– Study 02607 (ENCORE) 
Study 02607 was a randomized, open-label, active-controlled, non-inferiority, multicenter clinical 
study in 159 patients previously stabilised with ERT. In the Cerdelga group 34 (32%) patients received 
a dose escalation to 84 mg eliglustat twice daily and 51 (48%) to 127 mg twice daily during the 12-
month primary analysis period , and 21 (20%) patients continued to receive 42 mg twice daily. 
 
Based on the aggregate data from all doses tested in this study, Cerdelga met the criteria set in this 
study to be declared non-inferior to Cerezyme (imiglucerase) in maintaining patient stability. After 12 
months of treatment, the percentage of patients meeting the primary composite endpoint (composed of 
all four components mentioned in Table 4) was 84.8% [95% confidence interval 76.2% - 91.3%] for 
the Cerdelga group compared to 93.6% [95% confidence interval 82.5% - 98.7 %] for the Cerezyme 
group. Of the patients who did not meet stability criteria for the individual components, 12 of 15 
Cerdelga patients and 3 of 3 Cerezyme patients remained within therapeutic goals for GD1. 
  
There were no clinically meaningful differences between groups for any of the four individual disease 
parameters (see Table 4). 
 



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Table 4: Changes from baseline to Month 12 (primary analysis period) in patients with GD1 
switching to Cerdelga in study 02607 

 

Cerezyme 
(N=47)** 
Mean [95% CI] 

Cerdelga 
(N=99) 
Mean [95% CI] 

Spleen Volume 
 Percentage of Patients with stable 
spleen volume*a  100%  95.8% 

 Percentage Change in Spleen Volume 
MN (%)* -3.01 [-6.41, 0.40] -6.17 [-9.54, -2.79] 

Haemoglobin Level 
Percentage of Patients with stable 
haemoglobin levela 100%  94.9% 

Absolute Change in Haemoglobin 
Level (g/dL) 0.038 [-0.16, 0.23] -0.21 [-0.35, -0.07] 

Liver Volume 
Percentage of Patients with stable liver 
volumea 93.6%  96.0% 

Percentage Change in Liver Volume 
MN (%) 3.57 [0.57, 6.58] 1.78 [-0.15, 3.71] 

Platelet Count 
Percentage of Patients with stable 
platelet counta 100%  92.9% 

Percentage Change in Platelet Count 
(%) 2.93 [-0.56, 6.42] 3.79 [0.01, 7.57] 

 
MN = Multiples of Normal, CI = confidence interval 
* Excludes patients with a total splenectomy. 
** All patients transitioned to Cerdelga treatment after 52 weeks  
a The stability criteria based on changes between baseline and 12 months: haemoglobin level ≤1.5 g/dL decrease, platelet 
count ≤25% decrease, liver volume ≤20% increase, and spleen volume ≤25% increase. 
All patient number (N)= Per Protocol Population 

 
During the open-label long term treatment period with Cerdelga (extension phase) the percentage of 
patients with complete data meeting the composite stability endpoint was maintained at 84.6% 
(n=136) after 2 years, 84.4% (n=109) after 3 years and 91.1% (n=45) after 4 years. The majority of 
extension phase discontinuations were due to transition to commercial product from year 3 onwards. 
Individual disease parameters of spleen volume, liver volume, haemoglobin levels and platelet count 
remained stable through 4 years (see Table 5). 
 



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Table 5: Changes from Month 12 (primary analysis period) to Month 48 in patients with GD1 in 
the Long Term Treatment Period on Cerdelga in study 02607 
 

MN = Multiples of Normal, CI = confidence interval 
* Excludes patients with a total splenectomy. 
a Cerezyme/Cerdelga - Originally Randomized to Cerezyme 
b Cerdelga - Originally Randomized to Cerdelga 
 

 Year 2 Year 3 Year 4 

 Cerezyme 
/Cerdelgaa 

Mean [95% 
CI]  

Cerdelgab 
 

Mean [95% 
CI])  

Cerezyme 
/Cerdelgaa 

Mean [95% 
CI]  

Cerdelgab 
 

Mean [95% 
CI] 

Cerezyme 
/Cerdelgaa 

Mean [95% 
CI]  

Cerdelgab 
 

Mean [95% 
CI] 

Patients at start of year (N) 51 101 46 98 42 96 

Patients at end of year (N) 46 98 42 96 21 44 

Patients with available 
data (N) 

39 97 16 93 3 42 

Spleen Volume 

Patients with stable spleen 
volume (%)* 

31/33 (93.9) 
[0.798, 0.993] 

69/72 (95.8) 
[0.883, 0.991] 

12/12 (100.0)  
[0.735, 1.000] 

65/68 (95.6)  
[0.876, 0.991] 

2/2 (100.0) 
[0.158, 1.000] 

28/30 (93.3) 
[0.779, 0.992] 

Change in Spleen Volume 
MN (%)* 

-3.946[-8.80, 
0.91] 

-6.814[-10.61, -
3.02] 

-10.267[-20.12, 
-0.42] 

-7.126[-11.70, -
2.55] 

-27.530[-89.28, 
34.22] 

-13.945[-20.61, 
-7.28] 

Haemoglobin Level 

Patients with stable 
haemoglobin level (%) 

38/39 (97.4) 
[0.865, 0.999] 

95/97 (97.9) 
[0.927, 0.997] 

16/16 (100.0) 
[0.794, 1.000] 

90/93 (96.8) 
[0.909, 0.993] 

3/3 (100.0) 
(0.292, 1.000] 

42/42 (100.0) 
[0.916, 1.000] 

Change from baseline in 
Haemoglobin Level (g/dL) 

0.034[-0.31, 
0.38] 

-0.112[-0.26, 
0.04] 

0.363[-0.01, 
0.74] 

-0.103[-0.27, 
0.07] 

0.383[-1.62, 
2.39] 

0.290[0.06, 
0.53] 

Liver Volume 

Patients with stable liver 
volume (%) 

38/39 (97.4) 
(0.865, 0.999) 

94/97 (96.9) 
(0.912, 0.994) 

15/16 (93.8) 
[0.698, 0.998] 

87/93 (93.5) 
(0.865, 0.976) 

3/3 (100.0) 
[0.292, 1.000] 

40/42 (95.2) 
[0.838, 0.994] 

Change from baseline in 
Liver Volume MN (%) 

0.080[-3.02, 
3.18] 

2.486[0.50, 
4.47] 

-4.908[-11.53, 
1.71] 

3.018[0.52, 
5.52] 

-14.410[-61.25, 
32.43] 

-1.503[-5.27, 
2.26] 

Platelet Count 

Patients with stable 
platelet count (%) 

33/39 (84.6) 
[0.695, 0.941] 

92/97 (94.8) 
[0.884, 0.983] 

13/16 (81.3) 
[0.544, 0.960] 

87/93 (93.5) 
[0.865, 0.976] 

3/3 (100.0) 
[0.292, 1.000] 

40/42 (95.2) 
[0.838, 0.994] 

Change in Platelet Count 
(%) 

-0.363[-6.60, 
5.88] 

2.216[-1.31, 
5.74] 

0.719[-8.20, 
9.63] 

5.403[1.28, 
9.52] 

-0.163[-35.97, 
35.64] 

7.501[1.01, 
13.99] 

Composite Stability Endpoint 

Patients who are Stable on 
Cerdelga (%) 

30/39 (76.9) 
[0.607, 0.889] 

85/97 (87.6) 
[0.794, 0.934] 

 

12/16 (75.0) 
[0.476, 0.927] 

80/93 (86.0) 

[0.773, 0.923] 
 

3/3 (100.0) 
[0.292, 1.000] 

38/42 (90.5) 
[0.774, 0.973] 



13 

Clinical experience in CYP2D6 poor metabolisers (PMs) and ultra-rapid metabolisers (URMs) 
 
There is limited experience with Cerdelga treatment of patients who are PMs or URMs. In the primary 
analysis periods of the three clinical studies, a total of 5 PMs and 5 URMs were treated with Cerdelga. 
All PMs received 42 mg eliglustat twice daily, and four of these (80%) had an adequate clinical 
response. The majority of URMs (80%) received a dose escalation to 127 mg eliglustat twice daily, all 
of which had adequate clinical responses. The one URM who received 84 mg twice daily did not have 
an adequate response. 
 
The predicted exposures with 84 mg eliglustat once daily in patients who are PMs are expected to be 
similar to exposures observed with 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers 
(IMs). Patients who are URMs may not achieve adequate concentrations to achieve a therapeutic 
effect. No dosing recommendation for URMs can be given. 
 
Effects on skeletal pathology 
 
After 9 months of treatment, in Study 02507, bone marrow infiltration by Gaucher cells, as determined 
by the total Bone Marrow Burden (BMB) score (assessed by MRI in lumbar spine and femur) 
decreased by a mean of 1.1 points in Cerdelga treated patients (n=19) compared to no change in 
patients receiving placebo (n=20). Five Cerdelga-treated patients (26%) achieved a reduction of at 
least 2 points in the BMB score.  
 
After 18 and 30 months of treatment, BMB score had decreased by a mean 2.2 points (n=18) and 2.7 
(n=15), respectively for the patients originally randomised to Cerdelga, compared to a mean decrease 
of 1 point (n=20) and 0.8 (n=16) in those originally randomised to placebo.  
 
After 18 months of Cerdelga treatment in the open-label extension phase, the mean (SD) lumbar spine 
Bone Mineral Density T-score increased from -1.14 (1.0118) at Baseline (n=34) to -0.918 
(1.1601) (n=33) in the normal range. After 30 months and 4.5 years of treatment, the T-score further 
increased to -0.722 (1.1250) (n=27) and -0.533 (0.8031) (n=9), respectively.  
 
Results of study 304 indicate that skeletal improvements are maintained or continue to improve during 
at least 8 years of treatment with Cerdelga. 
 
In study 02607, lumbar spine and femur BMD T- and Z-scores were maintained within the normal 
range in patients treated with Cerdelga for up to 4 years. 
 
Electrocardiographic evaluation 
 
No clinically significant QTc prolonging effect of eliglustat was observed for single doses up to 
675 mg. 
Heart-rate corrected QT interval using Fridericia's correction (QTcF) was evaluated in a randomized, 
placebo and active (moxifloxacin 400 mg) controlled cross-over, single-dose study in 47 healthy 
subjects. In this trial with demonstrated ability to detect small effects, the upper bound of the one-
sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTcF was below 
10 msec, the threshold for regulatory concern. While there was no apparent effect on heart rate, 
concentration-related increases were observed for the placebo corrected change from baseline in the 
PR, QRS, and QTc intervals. Based on PK/PD modelling, eliglustat plasma concentrations 11-fold the 
predicted human Cmax are expected to cause mean (upper bound of the 95% confidence interval) 
increases in the PR, QRS, and QTcF intervals of 18.8 (20.4), 6.2 (7.1), and 12.3 (14.2) msec, 
respectively. 
 
Elderly 
 
A limited number of patients aged 65 years (n=10) and over were enrolled in clinical trials. No 
significant differences were found in the efficacy and safety profiles of elderly patients and younger 
patients. 



14 

Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Cerdelga in all subsets of the paediatric population in Gaucher disease Type 2 (see section 4.2 for 
information on paediatric use). 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Cerdelga in the subsets of the paediatric population from 24 months to less than 18 years in Gaucher 
disease Type 1 and Type 3 (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, 
with low oral bioavailability (<5%) due to significant first-pass metabolism. Eliglustat is a substrate of 
the efflux transporter P-gp. Food does not have a clinically relevant effect on eliglustat 
pharmacokinetics. Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once 
daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.   
 
Distribution 
 
Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in 
plasma.  After intravenous administration, the volume of distribution was 816 L, suggesting wide 
distribution to tissues in humans. Nonclinical studies demonstrated a wide distribution of eliglustat to 
tissues, including bone marrow. 
 
Biotransformation 
 
Eliglustat is extensively metabolized with high clearance, mainly by CYP2D6 and to a lesser extent 
CYP3A4. Primary metabolic pathways of eliglustat involve sequential oxidation of the octanoyl 
moiety followed by oxidation of the 2,3-dihydro-1,4-benzodioxane moiety, or a combination of the 
two pathways, resulting in multiple oxidative metabolites. 
 
Elimination 
 
After oral administration, the majority of the administered dose is excreted in urine (41.8%) and 
faeces (51.4%), mainly as metabolites. After intravenous administration, eliglustat total body 
clearance was 86 L/h. After repeated oral doses of 84 mg eliglustat twice daily, eliglustat elimination 
half-life is approximately 4-7 hours in non-PMs and 9 hours in PMs. 
 
Characteristics in specific groups 
 
CYP2D6 phenotype 
Population pharmacokinetic analysis shows that the CYP2D6 predicted phenotype based on genotype 
is the most important factor affecting pharmacokinetic variability. Individuals with a CYP2D6 poor 
metaboliser predicted phenotype (approximately 5 to 10% of the population) exhibit higher eliglustat 
concentrations than intermediate or extensive CYP2D6 metabolisers. 
 
Gender, body weight, age, and race 
Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or 
no impact on the pharmacokinetics of eliglustat. 
 
Hepatic impairment:    
Effects of mild and moderate hepatic impairment were evaluated in a single dose phase 1 study. After 
a single 84 mg dose, eliglustat Cmax and AUC were 1.2- and 1.2-fold higher in CYP2D6 extensive 
metabolisers (EMs) with mild hepatic impairment, and 2.8- and 5.2-fold higher in CYP2D6 extensive 



15 

metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive 
metabolisers (EMs).  
 
After repeated 84 mg twice daily doses of Cerdelga, Cmax and AUC0-12 are predicted to be 2.4- and 2.9-
fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment and 6.4- and 8.9-
fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to 
healthy CYP2D6 extensive metabolisers (EMs). 
 
After repeated 84 mg once daily doses of Cerdelga, Cmax and AUC0-24 are predicted to be 3.1- and 3.2 -
fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to 
healthy CYP2D6 extensive metabolisers (EMs ) receiving Cerdelga 84 mg twice daily (see sections 
4.2 and 4.4).  
Steady state PK exposure could not be predicted in CYP2D6 intermediate metabolisers (IMs) and poor 
metabolisers (PMs) with mild and moderate hepatic impairment due to limited or no single-dose data. 
The effect of severe hepatic impairment was not studied in subjects with any CYP2D6 phenotype (see 
sections 4.2, 4.3 and 4.4).  
 
Renal impairment:   
Effect of severe renal impairment was evaluated in a single dose phase 1 study. After a single 84 mg 
dose, eliglustat Cmax and AUC were similar in CYP2D6 extensive metabolisers (EMs) with severe 
renal impairment and healthy CYP2D6 extensive metabolisers (EMs).  
 
Limited or no data were available in patients with ESRD and in CYP2D6 intermediate metabolisers 
(IMs) or poor metabolisers(PMs)  with severe renal impairment (see sections 4.2 and 4.4). 
 
5.3 Preclinical safety data 
 
The principal target organs for eliglustat in toxicology studies are the GI tract, lymphoid organs, the 
liver in rat only and, in the male rat only, the reproductive system. Effects of eliglustat in toxicology 
studies were reversible and exhibited no evidence of delayed or recurring toxicity. Safety margins for 
the chronic rat and dog studies ranged between 8-fold and 15-fold using total plasma exposure and 1- 
to 2-fold using unbound (free fraction) plasma exposures. 
 
Eliglustat did not have effects on CNS or respiratory functions. Concentration-dependent cardiac 
effects were observed in nonclinical studies: inhibition of human cardiac ion channels, including 
potassium, sodium, and calcium, at concentrations ≥ 7-fold of predicted human Cmax; sodium ion 
channel-mediated effects in an ex-vivo electrophysiology study in dog Purkinje fibres (2-fold of 
predicted human unbound plasma Cmax); and increases in QRS and PR intervals in dog telemetry and 
cardiac conduction studies in anaesthesised dogs, with effects seen at concentrations 14-fold of 
predicted human total plasma Cmax, or 2-fold of predicted human unbound plasma Cmax. 
   
Eliglustat was not mutagenic in a standard battery of genotoxicity tests and did not show any 
carcinogenic potential in standard lifetime bioassays in mice and rats. Exposures in the carcinogenicity 
studies were approximately 4-fold and 3-fold greater in mice and rats, respectively, than the mean 
predicted human eliglustat total plasma exposure, or less than 1-fold using unbound plasma exposure. 
 
In mature male rats, no effects on sperm parameters were observed at systemically non-toxic doses. 
Reversible inhibition of spermatogenesis was observed in the rat at 10-fold of predicted human 
exposure based on AUC, a systemically toxic dose. In rat repeated dose toxicity studies, seminiferous 
epithelial degeneration and segmental hypoplasia of the testes was seen at 10-fold of predicted human 
exposure based on AUC. 
 
Placental transfer of eliglustat and its metabolites was shown in the rat. At 2 and 24 hours post-dose, 
0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively. 
 
At maternal toxic doses in rats, foetuses showed a higher incidence of dilated cerebral ventricles, 
abnormal number of ribs or lumbar vertebrae, and many bones showed poor ossification. 



16 

Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure 
(based on AUC). 
 
A lactation study in the rat showed that 0.23% of labelled dose was transferred to pups during 24 
hours post-dose, indicating milk excretion of eliglustat and/or its related materials.   
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule contents 
Microcrystalline cellulose  
Lactose monohydrate  
Hypromellose 
Glycerol dibehenate 
 
Capsule shell 
Gelatin 
Potassium aluminium silicate (E555) 
Titanium dioxide (E171) 
Yellow iron oxide (E172) 
Indigotine (E132) 
 
Printing ink 
Shellac  
Black iron oxide (E172) 
Propylene glycol 
Ammonia solution, concentrated 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions.  
 
6.5 Nature and contents of container  
 
PETG/COC.PETG/PCTFE-aluminium blister  
 
Each blister wallets contains 14 hard capsules. 
Each pack contains 14, 56 or 196 hard capsules. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 



17 

7. MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/974/001 56 capsules 
EU/1/14/974/002  196 capsules 
EU/1/14/974/003 14 capsules 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 January 2015 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
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/
http://www.ema.europa.eu/


18 

 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER  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 

 



19 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Genzyme Ireland, Ltd 
IDA Industrial Park 
Old Kilmeaden Road, 
Waterford Ireland 
 
 
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 (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/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 marketing authorisation holder (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. 
 
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 of Cerdelga in each Member State the Marketing Authorisation Holder (MAH) must 
agree the content and format of the educational programme, including communication media, 
distribution modalities, and any other aspects of the programme, with the National Competent 
Authority.  

The MAH shall ensure that in each Member State where Cerdelga is marketed, all healthcare 
professionals who are expected to prescribe Cerdelga are provided with a prescriber guide.  

The prescriber guide shall contain the following key elements: 

o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease 
type 1 (GD1).  



20 

o Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 
to determine the CYP2D6 metaboliser status. Cerdelga is indicated in patients who are 
CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive 
metabolisers (EMs). 

o The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate 
metabolisers (IMs) and extensive metabolisers (EMs). The recommended dose is 84 mg 
eliglustat once daily in CYP2D6 poor metabolisers (PMs).  

o Patients should be informed that consumption of grapefruit or its juice should be avoided. 

o Eliglustat is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) 
or extensive metabolisers (EMs) who are taking a strong or moderate CYP2D6 inhibitor 
concomitantly with a strong or moderate CYP3A inhibitor.  Eliglustat is also 
contraindicated in patients who are CYP2D6 poor metabolisers (PMs) taking a strong 
CYP3A inhibitor. Use of eliglustat under these conditions results in substantially elevated 
plasma concentrations of eliglustat. This may cause mild increases in the PR, QRS, and 
QTc intervals. 

o Use of eliglustat with strong CYP3A inducers substantially decreases the exposure to 
eliglustat, which may reduce the therapeutic effectiveness; therefore concomitant 
administration is not recommended. Use of a moderate CYP3A inhibitor with eliglustat is 
not recommended in PMs. 

o A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 
inhibitor is used concomitantly in intermediate metabolisers (IMs) and extensive 
metabolisers (EMs). 

o Caution should be used with moderate CYP2D6 inhibitors in intermediate metabolisers 
(IMs) and extensive metabolisers (EMs). Caution should be used with strong or moderate 
CYP3A inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs). 
Caution should be used with weak CYP3A inhibitors in poor metabolisers (PMs).  

o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is 
contraindicated. In CYP2D6 extensive metabolisers (EMs) with mild or moderate 
hepatic impairment taking a strong or moderate CYP2D6 inhibitor, Cerdelga is 
contraindicated. 

o In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak 
CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg 
eliglustat once daily should be considered. 

o In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree 
of hepatic impairment, Cerdelga is not recommended. 

The MAH shall ensure that in each Member State where Cerdelga is marketed, all patients who are 
prescribed Cerdelga are provided with a patient alert card. The patient alert card shall contain the 
following key elements: 

Information for healthcare professionals: 

o This patient is using eliglustat (Cerdelga) for the treatment of Gaucher Disease type 1.  

o Eliglustat should not be used concomitantly with medicines that may have an impact on 
liver enzymes that play a role in the metabolism of eliglustat. In addition, patient’s 
hepatic or renal status may have an impact on the metabolism of eliglustat. 



21 

o Using eliglustat together with such products or in patients with hepatic or renal 
impairment may either make eliglustat less effective, or it may increase the eliglustat 
levels in the patient’s blood.  

Information for the patient: 

o Always consult the doctor who prescribed eliglustat before you start using other 
medicines.  

 o Do not consume grapefruit products.  

• Obligation to conduct post-authorisation measure  

The MAH shall complete, within the stated timeframe, the below measure: 

Description Due date 

In order to investigate the long-term safety of eliglustat in patients prescribed eliglustat, the 
MAH is to create a sub-registry to the International Collaborative Gaucher Group (ICGG) 
Gaucher Registry to collect safety data according to an agreed protocol.  

Reports from the sub-
registry are to be 
submitted with each 
PSUR.  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cerdelga 84 mg hard capsules  
eliglustat  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each capsule contains 84 mg of eliglustat (as tartrate)  
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
56 hard capsules 
196 hard capsules 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
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 WARNINGS, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



25 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/14/974/001 56 capsules 
EU/1/14/974/002 196 capsules 
EU/1/14/974/003 14 capsules 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cerdelga  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE PACKAGING FOR SINGLE BLISTER SLEEVE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cerdelga 84 mg hard capsules  
eliglustat  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 84 mg of eliglustat (as tartrate) 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 hard capsules 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
Press down at 1 and at the same time pull at 2. 
 
 
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 WARNINGS, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



27 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/14/974/001 56 capsules 
EU/1/14/974/002 196 capsules 
EU/1/14/974/003 14 capsules 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cerdelga  
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



28 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER / WALLET 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cerdelga 84 mg hard capsules  
eliglustat 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Genzyme Europe B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. OTHER 
 
 
 



29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



30 

 
Package leaflet: Information for the patient 

 
Cerdelga 84 mg hard capsules  

eliglustat  
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking 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 doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Cerdelga is and what it is used for  
2. What you need to know before you take Cerdelga 
3. How to take Cerdelga  
4. Possible side effects  
5. How to store Cerdelga  
6. Contents of the pack and other information 
 
 
1. What Cerdelga is and what it is used for 
 
Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult 
patients with Gaucher disease type 1. 
 
Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is 
not effectively broken down by your body. As a result glucosylceramide builds up in your spleen, liver 
and bones. The build-up prevents these organs from working properly. Cerdelga contains the active 
substance eliglustat which decreases the production of glucosylceramide, thereby preventing its build-
up. In turn this helps your affected organs to work better. 
 
People differ in the speed that their body breaks down this medicine. As a result the amount of this 
medicine in the blood can differ between patients which could affect how a patient would respond. 
Cerdelga is meant to be used in patients whose body breaks down this medicine at normal speed 
(known as intermediate metabolisers and extensive metabolisers) or slow speed (known as poor 
metabolisers). Your doctor will determine if Cerdelga is suitable for you before you start taking it, 
using a simple laboratory test. 
 
Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as 
prescribed by your doctor to gain the maximum benefit from your medicine. 
 
 
2. What you need to know before you take Cerdelga  
 
Do not take Cerdelga 

- If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in 
section 6). 

- If you are an intermediate or extensive metaboliser and use medicines  known as strong or 
moderate CYP2D6 inhibitors (examples are quinidine and terbinafine) used in combination 



31 

with strong or moderate CYP3A inhibitors (examples are erythromycin and itraconazole). The 
combination of these medicines will interfere with your body’s ability to break down Cerdelga 
and this can result in higher levels of the active substance in your blood (see the section ‘Other 
medicines and Cerdelga’ for an expanded list of medicines). 

- If you are a poor metaboliser and use medicines known as strong CYP3A inhibitors (for 
example itraconazole). Medicines of this type will interfere with your body’s abilty to break 
down Cerdelga and this can result in higher levels of the active substance in your blood (see 
the section ‘Other medicines and Cerdelga’ for an expanded list of medicines). 

- If you are an extensive metaboliser and you have severely reduced liver function. 
- If you are an extensive metaboliser and you have mildly or moderately reduced liver function 

while taking a strong or moderate CYP2D6 inhibitor. 
 
Warnings and precautions  
Talk to your doctor or pharmacist before taking Cerdelga, if you: 

•  are currently treated, or about to start treatment with any of the medicines listed in section 
‘Other medicines and Cerdelga.’ 

• have had a heart attack or heart failure. 
• have a slow heart rate. 
• have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome. 
• have any other heart problems. 
• are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine, 

amiodarone or sotalol. 
• are an extensive metaboliser and you have moderately reduced liver function. 
• are an intermediate or poor metaboliser and you have any level of reduced liver function. 
• are an intermediate or poor metaboliser and you have reduced kidney function.  
• are an end stage renal disease (ESRD) patient. 

  
Children and adolescents 
Cerdelga has not been tested in children and adolescents under 18 years of age. Do not give this 
medicine to children or adolescents. 
 
Other medicines and Cerdelga 
Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other 
medicines. 
 
Medicines that must not be taken in combination with each other and Cerdelga 
Cerdelga must not be used with certain type of medicines. These medicines can interfere with your 
body’s ability to break down Cerdelga and this can result in higher levels of Cerdelga in your blood. 
These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A 
inhibitors. There are many medicines in these categories and depending on how your body breaks 
down Cerdelga the effects may differ from person to person. Please speak to your doctor regarding 
these medicines before you start taking Cerdelga. Your doctor will determine which medicines you 
can use based on how fast your body breaks down eliglustat. 
 
Medicines that may increase the level of Cerdelga in the blood such as: 

• paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide – antidepressants 
(used to treat depression) 

• dronedarone, quinidine, verapamil – antiarrhythmic medicines (used to treat irregular 
heartbeat) 

• ciprofloxacin, clarithromycin, erythromycin, telithromycin – antibiotics (used to treat 
infections) 

• terbinafine, itraconazole, fluconazole, posaconazole, voriconazole – antifungals (used to treat 
fungal infections) 

• mirabegron – used to treat overactive bladders 
• cinacalcet – calcimimetic (used in some dialysis patients and specific cancers) 



32 

• atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir – 
antiretrovirals (used to treat HIV) 

• cobicistat – used to improve the effects of antiretrovirals (used to treat HIV) 
• aprepitant – antiemetic (used to reduce vomiting) 
• diltiazem – antihypertensive (used to increase blood flow and decrease heart rate) 
• conivaptan – diuretic (used to increase low blood sodium levels) 
• boceprevir, telaprevir – antiviral (used to treat Hepatitis C) 
• imatinib – anticancer (used to treat cancer) 
• amlopidine, ranolazine  –  used to treat angina pectoris  
• cilostazol – used to treat cramp-like pain in your legs when you walk caused by insufficient 

blood supply in your legs 
• isoniazid – used to treat tuberculosis. 
• cimetidine, ranitidine – antacids (used to treat indigestion) 
• goldenseal – (also known as Hydrastis canadensis) a herbal preparation obtained without a 

prescription, used as a digestive aid. 
 
Medicines that may decrease the level of Cerdelga in the blood: 

• rifampicin, rifabutin – antibiotics (used to treat infections) 
• carbamazepine, phenobarbital, phenytoin –anti-epileptics (used to treat epilepsy and seizures) 
• St. John’s wort – (also known as Hypericum perforatum) a herbal preparation obtained 

without a prescription, used to treat depression and other conditions  
 
Cerdelga may increase the level of the following types of medicines in the blood: 

• dabigatran – anticoagulant (used to thin the blood) 
• phenytoin – anti-epileptic (used to treat epilepsy and seizures) 
• nortryptyline, amitriptyline, imipramine, desipramine – antidepressants (used to treat 

depression) 
• phenothiazines – antipsychotics (used to treat schizophrenia and psychosis) 
• digoxin –used to treat heart failure and atrial fibrillation 
• colchicine – used to treat gout 
• metoprolol – used to lower blood pressure and/or reduce heart rate 
• dextromethorphan – cough medicine 
• atomoxetine – used to treat attention deficit hyperactivity disorder (ADHD) 
• pravastatin – used to lower cholesterol and prevent heart disease 

 
Taking Cerdelga with food and drink 
Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your 
blood. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor 
who will discuss with you whether you can take this medicine during your pregnancy. 
 
The active substance in this medicine has been shown to pass in trace amounts into breast milk in 
animals. Breast-feeding is not recommended during treatment with this medicine. Tell your doctor if 
you are breast-feeding. 
 
There are no known effects on fertility at normal doses. 
 
Driving and using machines 
Cerdelga has negligible or no influence on the ability to drive and use machines. 
 
Cerdelga contains lactose  
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicine. 
 



33 

 
3. How to take Cerdelga 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
If you are an intermediate metaboliser or extensive metaboliser: 
Swallow one 84 mg capsule whole twice a day with water. It may be taken with or without food. Take 
one capsule in the morning and one capsule at night.  
 
If you are a poor metaboliser: 
Swallow one 84 mg capsule whole once a day with water. It may be taken with or without food. Take 
one capsule at the same time every day.  
 
Do not open, crush, dissolve, or chew the capsule before swallowing it. If you cannot swallow the 
capsule whole, tell your doctor. 
 
Continue taking Cerdelga every day for as long as your doctor tells you. 
 
How to pull the blister/wallet from the sleeve 
While pressing your thumb and finger together at one end of the sleeve (1) gently pull the 
blister/wallet out to open the sleeve (2). 
 
If you take more Cerdelga than you should 
If you take more capsules than you were told to, consult your doctor immediately. You may 
experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and light-
headedness. 
 
If you forget to take Cerdelga 
Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Cerdelga 
Do not stop taking Cerdelga without talking to your doctor.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Common (may affect up to 1 in 10 people): 

• Headache 
• Dizziness 
• Change in taste (dysgeusia) 
• Palpitations 
• Throat irritation 
• Heartburn (dyspepsia) 
• Feeling sick (nausea) 
• Diarrhoea 
• Constipation 
• Abdominal pain 
• Stomach ache (upper abdominal pain) 
• Acid reflux disease (gastrooesophageal reflux disease) 
• Bloating (abdominal distension) 
• Inflammation of the stomach (gastritis) 



34 

• Difficulty swallowing (dysphagia) 
• Vomiting 
• Dry mouth 
• Gas (flatulence) 
• Dry skin 
• Hives (urticaria) 
• Joint pain (arthalagia) 
• Pain in arms, legs or back 
• Tiredness (fatigue) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Cerdelga 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after 
‘EXP’. The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Cerdelga contains  

• The active substance is eliglustat (as tartrate). Each capsule contains 84 mg eliglustat. 
• The other ingredients are:  

o In the capsule: microcrystalline cellulose, lactose monohydrate (see section 2 under 
‘Cerdelga contains lactose’), hypromellose and glycerol dibehenate. 

o In the capsule shell: gelatin, potassium aluminium silicate (E555), titanium dioxide 
(E171), yellow iron oxide (E172) and indigotine (E132). 

o In the printing ink: shellac, black iron oxide (E172), propylene glycol and ammonia 
solution, concentrated. 

 
What Cerdelga looks like and contents of the pack 
Cerdelga capsules have a pearl blue-green opaque cap and a pearl white opaque body with “GZ02” 
printed in black on the capsule. 
 
Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules 
each or 196 hard capsules in 14 blister wallets of 14 capsules each  
 
Not all packs may be marketed in your country. 
 
Marketing Authorisation Holder  
Genzyme Europe B.V. 
Paasheuvelweg 25 
1105 BP Amsterdam 
The Netherlands 

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


35 

 
Manufacturer 
Genzyme Ireland Ltd 
IDA Industrial Park  
Old Kilmeaden Road  
Waterford 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg 
Sanofi Belgium 
Tél/Tel: + 32 2 710 54 00 
 

Lietuva 
UAB „SANOFI-AVENTIS LIETUVA“ 
Tel. +370 5 275 5224 
 

България 
SANOFI-BULGARIA EOOD 
Tел: +359 2 9705300 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
Tel: +36 1 505 0050 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Malta 
Sanofi S.p.A. 
Tel: +39 02 39394275 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 04 36 996 
Tel. aus dem Ausland: +49 69 305 70 13 
 

Norge 
sanofi-aventis Norge AS 
Tlf: + 47 67 10 71 00 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel. +372 6 273 488 
 

Österreich 
sanofi-aventis GmbH 
Tel: + 43 1 80 185 - 0 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 1600 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

España 
sanofi-aventis, S.A. 
Tel: +34 93 485 94 00 
  

Portugal 
Sanofi – Produtos Farmacêuticos, Lda. 
Tel: +351 21 35 89 400 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger: +33 1 57 63 23 23 
 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 
 

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 4800 



36 

 
Ireland 
sanofi-aventis Ireland Ltd. T/A SANOFI 
Tel: +353 (0) 1 403 56 00 
 
Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel.:  +421 2 33 100 100 
 

Italia 
Sanofi S.p.A. 
Tel: 800536389 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: + 358 201 200 300 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

 
Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 

  
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.  
 
 
 
 

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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