ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Cystadane 1 g oral powder
2.
1 g of powder contains 1 g of betaine anhydrous.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
For full list of excipients, see section 6.1.
3.
Oral powder
White free flowing powder.
4.
Adjunctive treatment of homocystinuria, involving deficiencies or defects in:
•
cystathionine beta-synthase (CBS),
•
5,10-methylene
-
tetrahydrofolate reductase (MTHFR),
•
cobalamin cofactor metabolism (cbl).
Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin
B12 (cobalamin), folate and a specific diet.
Cystadane treatment should be supervised by a physician experienced in the treatment of patients with
homocystinuria.
The recommended total daily dose in adult and paediatric patients over 10 years of age is 6 g per day
administered orally in divided doses of 3 g two times per day. However, dose titration may be
preferable in paediatric patients.
In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day
given in 2 doses daily; increasing the frequency above twice daily and/or the dose above
150 mg/kg/day does not improve the homocysteine-lowering effect.
Use in hepatic or renal impairment
Experience with betaine therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis
has demonstrated no need to adapt the dose regimen of Cystadane.
The bottle should be lightly shaken before opening. Three measuring spoons are provided which
dispense either 100 mg, 150 mg or 1 g of betaine anhydrous. It is recommended that a heaped
measuring spoon is removed from the container and a flat surface e.g. base of a knife is drawn across
the top of the measure. This will give the following doses: small measure 100 mg, middle size
measure 150 mg and large measure 1 g of betaine anhydrous.
The powder should be mixed with water, juice, milk, formula or food until completely dissolved and
ingested immediately after mixing.
2
Therapeutic monitoring:
The aim of treatment is to keep plasma
levels of total homocysteine below 15 µM or as low as
possible. The steady-state response usually occurs within a month.
Hypersensitivity to betaine.
Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks
to 6 months of starting betaine therapy (see section 4.8). Complete recovery was seen after treatment
discontinuation:
- Plasma methionine level should be monitored, at start of treatment and periodically thereafter.
The plasma methionine concentrations should be kept below 1000 µM.
- If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes
appear, plasma methionine level and compliance to the diet should be checked and treatment with
Cystadane interrupted.
- If symptoms of cerebral oedema recur after re-introduction of treatment then betaine therapy
should be discontinued indefinitely.
To minimize the risk of potential drug interactions, it is advisable to leave 30 minutes between the
intake of betaine and amino acids mixtures and/or medicinal products containing vigabatrin and
GABA analogues (see section 4.5).
No interaction studies have been performed.
Based on
in vitro
data, betaine might interact with amino acids mixtures and medicinal products
containing vigabatrin and GABA analogues.
Pregnancy
Data on a limited number (7) of exposed pregnancies indicate no adverse event of betaine on
pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic data
are available. Animal reproduction studies have not been conducted. During pregnancy, administering
betaine in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma
homosysteine would be compatible with good maternal and foetal outcomes.
However
, Cystadane
should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is not known whether betaine is excreted in human milk (although its metabolic precursor, choline,
occurs at high levels in human milk). Because of lack of data, caution should be exercised when
prescribing Cystadane to breast-feeding women.
No studies on the effects on the ability to drive and use machines have been performed.
3
Experience derived from exposure to betaine in about 1,000 patients.
Reported adverse reactions are listed below, by system organ class and by frequency.
Frequencies are defined as
:
very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon
(≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000). Within each frequency
grouping, undesirable effects are presented in order of decreasing seriousness.
Metabolism and nutrition disorders
Uncommon: anorexia
Psychiatric disorders
Uncommon: agitation, depression, irritability,
personality disorder, sleep disturbed
Nervous system disorders
Uncommon: brain oedema*
Uncommon: dental disorders, diarrhoea, glossitis,
nausea, stomach discomfort, vomiting
Skin and subcutaneous tissue disorders Uncommon: hair loss, hives, skin odour abnormal
Renal and urinary disorder Uncommon: urinary incontinence
Investigations Very common: blood methionine increased*
*Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks
to 6 months of starting betaine therapy, with complete recovery after treatment discontinuation. High
increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
As cerebral oedema has also
been reported in patients with hypermethioninemia, secondary
hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action.
For specific recommendations, refer to section 4.4.
Gastrointestinal disorders
No case of overdose has been reported.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Alimentary tract and metabolism product, ATC code: A16A A06.
Betaine was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e.
CBS deficiency; MTHFR deficiency and cbl defect. The extent of this effect was dependent on the
absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia.
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients
with homocystinuria. As a result, plasma levels of homocysteine should decrease in these patients, to
20-30 % of pre-treatment levels.
Elevated homocysteine plasma levels are associated with cardiovascular events such as thrombosis,
osteoporosis, skeletal abnormalities, and optic lens dislocation. In observational studies, clinical
improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about
75% of patients taking betaine. Most of these patients were also receiving other treatments such as
vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses. In
most cases, adding betaine resulted in a further reduction in plasma homocysteine level. It is likely that
due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may
be an element of overestimation in the clinical effects of betaine treatment. Late detection of
homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage
to connective tissue (ophtalmological, skeletal) that can not be corrected by further therapy. The
available clinical data do not allow correlating posology and clinical efficacy. There is no evidence of
development of tolerance.
4
Betaine has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels
in patients with MTHFR deficiency and cbl defects. In CBS-deficient patients without dietary
restriction of methionine, excessive accumulation of methionine has been observed. In a few cases,
increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
Monitoring plasma homocysteine levels has demonstrated that the onset of action of betaine occurred
within several days and that a steady
-
state
response was achieved within one month.
In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day
given in 2 doses daily; increasing the frequency above twice daily and/or the dose above 150
mg/kg/day does not improve the homocysteine-lowering effect.
Betaine supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid
of patients with homocystinuria.
Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these
concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine
methyl transferase pathway.
5.2 Pharmacokinetic properties
The absolute bioavailability of betaine has not been determined.
In healthy adult volunteers (age
between 21 to 49 years), after a single oral dose of betaine (50 mg/kg),
absorption was rapid
(t
max
=
0.9 ± 0.3 hours and a C
max
= 0.9 ± 0.2 mM). Betaine was rapidly distributed into a relatively
large volume (
V/F =
1.3 l/kg), with a slow elimination rate (mean half life
= 14 h, mean total body
clearance
, CL/F,
= 84 ml/h/kg), renal clearance being negligible (5% of total body clearance),
assuming 100% bioavailability. After a repeated dose regimen of 100 mg/kg/day for 5 days, the
absorption kinetics did not change but the distribution half life was prolonged significantly (up to
36 h), indicating saturable transport and redistribution processes.
The pharmacokinetic data of homocystinuric patients on long-term betaine supplementation are very
similar to those of healthy volunteers. This demonstrates that differences in betaine kinetics are most
probably due to betaine depletion in untreated homocystinuria and are only meaningful for the initial
treatment.
5.3 Preclinical safety data
At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats.
Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine. A
standard battery of genotoxicity test reveals no specific hazard for humans.
6.
6.1 List of excipients
None.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened bottle: 3 years
5
After the first opening: 3 months.
6.4 Special precautions for storage
C.
Keep the bottle tightly closed in order to protect from moisture.
°
6.5
Nature and contents of container
HDPE bottles with a child resistant closure.
Each pack contains 1 bottle with 180 g of powder.
Three measuring spoons are included in each pack.
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7.
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
8.
EU/1/06/379/001
9.
15/02/2007
6
Do not store above 25
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
7
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Orphan Europe S.A.R.L.
Immeuble "Le Wilson"
70 avenue du Général de Gaulle
F-92800 Puteaux
France
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (see annex I : Summary of Product
Characteristics, section 4.2)
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the
product is placed on the market and for as long as the marketed product remains in use.
The Marketing Authorisation Holder commits to performing the studies as detailed in the
Pharmacovigilance Plan.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
Cystadane 1 g oral powder
Betaine anhydrous
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 g of powder contains 1 g of betaine anhydrous.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
3.
LIST OF EXCIPIENTS
4.
180 g of oral powder and three measuring spoons.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Lightly shake the bottle before opening.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP {month/year}
Shelf life after the first opening: 3 months.
Opened:
9.
SPECIAL STORAGE CONDITIONS
C.
Keep the bottle tightly closed in order to protect from moisture.
°
11
Do not store above 25
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
EU/1/06/379/001
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Cystadane 1 g oral powder
12
PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING
BOTTLE LABEL
1.
Cystadane 1 g oral powder
Betaine anhydrous
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 g of powder contains 1 g of betaine anhydrous.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
3.
LIST OF EXCIPIENTS
4.
180 g of oral powder.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Lightly shake the bottle before opening.
Read the package leaflet before use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP {month/year}
Shelf life after the first opening: 3 months.
9.
SPECIAL STORAGE CONDITIONS
C.
Keep the bottle tightly closed in order to protect from moisture.
°
13
Do not store above 25
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
EU/1/06/379/001
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Cystadane 1 g oral powder
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cystadane 1 g oral powder
Betaine anhydrous
Read all of this leaflet carefully before you start taking this medicine.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What Cystadane is and what it is used for
2.
Before you take Cystadane
4.
Possible side effects
5
How to store Cystadane
6.
Further information
1.
WHAT CYSTADANE IS AND WHAT IT IS USED FOR
Cystadane contains betaine anhydrous which is intended to be an adjunctive treatment of
homocystinuria, an inborn error of metabolism.
Methionine is an amino acid which is present in regular food protein (e.g. meat, fish, milk, cheese,
eggs). It is converted into homocysteine which is then normally converted into cysteine during
digestion. Homocystinuria is a disease caused by the accumulation of homocysteine which is not
converted to cysteine and is characterized by formation of clots in the veins, bone weakness, and
skeletal and crystalline lens abnormalities. The use of Cystadane together with other treatments such
as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated homocysteine levels
in your body.
2.
BEFORE YOU TAKE CYSTADANE
Do not take Cystadane
If you or your child are allergic (hypersensitive) to betaine.
Take special care with Cystadane
If you notice side effects like headaches, vomiting or a change in your vision, please contact your
doctor immediately, they could be signs of a brain oedema. In that case your doctor will monitor your
methionine level in your body and may review your diet. Your treatment with betaine may need to be
interrupted.
If you are treated with Cystadane and with an amino-acid mixture and if you need to take other
medicines at the same time, leave 30 minutes between the intake (see “taking other medicines”).
Taking other medicines
If you are taking amino-acid mixture or medicines such as vigabatrin or Gaba analogues, please tell
your doctor as they might interact with your treatment with betaine.
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
16
-
Keep this leaflet. You may need to read it again.
3.
How to take Cystadane
Pregnancy and breast-feeding
Please inform your doctor if you are pregnant or breast-feeding. Your doctor will decide if the medicine
may be used during pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
3.
HOW TO TAKE CYSTADANE
Always take Cystadane exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The daily dose in adults, adolescents and children over 10 years of age is 6 g per day divided in
2 doses of 3 g per day.
In children less than 10 years of age, the daily dose will be calculated from the child’s body weight by
your doctor.
You or your child will therefore need regular blood tests to determine the correct daily dose.
The use of this medicine will be supervised by a physician experienced in the treatment of patients
with homocystinuria.
Cystadane should be taken orally (by mouth).
To measure the dose:
•
shake the bottle lightly before opening
•
take the correct measuring spoon:
•
the small spoon measures 100 mg of betaine anhydrous powder;
•
the middle size spoon measures 150 mg of betaine anhydrous powder ;
•
the large spoon measures 1 g of betaine anhydrous powder.
•
take a heaped spoonful of powder out of the bottle
•
pass the flat back of a knife over the top of the spoon
•
the powder left in the spoon is one spoonful
•
take the correct number of spoonfuls of powder from the bottle
Mix the measured dose of powder with water, juice, milk, formula or food until completely dissolved
and ingest immediately after mixing.
If you forget to take Cystadane:
Do not take a double dose to make up for forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Cystadane can cause side effects, although not everybody gets them.
The following side effects were reported as follows: very common (more than 1 out of 10 persons),
common (more than 1 out of 100 persons and less than 1 out of 10 persons), uncommon (more than 1
out of 1,000 persons and less than 1 out of 100 persons), rare (more than 1 out of 10,000 persons and
less than 1 out of 1,000 persons), very rare (less than 1 out of 10,000 persons).
17
Very common:
blood methionine increased.
Uncommon:
decreased appetite, agitation, depression, irritability, personality disorder, sleep
disturbance, oedema of the brain (see heading “Take special care with Cystadane” in section 2), dental
disorders, diarrhoea, inflammation of the
tongue, nausea, stomach discomfort, vomiting, hair loss,
hives, skin odour abnormality and urinary incontinence.
Since some of these side effects are serious, ask your doctor to explain their warning signs.
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.
HOW TO STORE CYSTADANE
Keep out of the reach and sight of children
Do not use Cystadane after the expiry date which is stated on the bottle label and the carton after EXP.
The expiry date refers to the last day of that month.
C.
Keep the bottle tightly closed in order to protect from moisture.
After the first opening of the bottle, the product should be used within 3 months.
°
Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.
6.
FURTHER INFORMATION
What Cystadane contains
- The active substance is betaine anhydrous. 1 g of oral powder contains 1 g of betaine anhydrous.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
- There is no other ingredient.
What Cystadane looks like and contents of the pack
Cystadane is a white crystalline oral powder. It is presented in bottles with child resistant closures.
Each bottle contains 180 g of betaine anhydrous powder. Three measuring spoons are enclosed in the
carton to assist you in measuring out the dose prescribed by your doctor.
Marketing Authorisation Holder and Manufacturer
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
18
Do not store above 25
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
Belgique/België/Belgien
Orphan Europe Benelux
Koning Albert I, Iaan 48 bus 3
B-1780 Wemmel (Brussels)
Tél/Tel: +32 2 46101 36
Luxembourg/Luxemburg
Orphan Europe Benelux
Koning Albert I, Iaan 48 bus 3
B-1780 Wemmel (Brussels)
Belgique/Belgien
Tél/Tel: +32 2 46101 36
България
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Германия
Teл.: + 49 6074 812160
Magyarország
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Németország
Tel : +49 6074 812160
Česká republika
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Německo
Tel : +49 6074 812160
Malta
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
Tel : +33 1 47 73 64 58
Danmark
Swedish Orphan A/S,
Wilders Plads 5,
DK – 1403 København K
Tlf : +45 32 96 68 69
Nederland
Orphan Europe Benelux
Koning Albert I Iaan 48 bus 3
B-1780 Wemmel (Brussels)
België
Tel: +32 2 46101 36
Deutschland
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Tel : +49 (0)6074 812160
Norge
Swedish Orphan A/S
Trollåsveien 6n
N-1414 Trollåsen
Tlf : +47 66 82 34 00
Eesti
Orphan Europe AB
Banérgatan 37
S-115 22 Stockholm
Rootsi
Tel : +46 8 545 80 230
Österreich
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Deutschland
Tel : +49 6074 812160
Ελλάδα
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
Γαλλία
Τηλ: +33 1 47 73 64 58
Polska
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Niemcy
Tel : +49 6074 812160
19
España
Orphan Europe, S.L.
Gran via de les Cortes Catalanes, 649
Despacho, n°1
E-08010 Barcelona
Tel: +34 93 342 51 20
Portugal
Orphan Europe, S.L.
Gran via de les Cortes Catalanes, 649
Despacho, n°1
E-08010 Barcelona
Espanha
Tel : +34 93 342 51 20
France
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
France
Tél : +33 1 47 73 64 58
România
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Germania
Tel: + 49 6074 812160
Ireland
Orphan Europe (UK) Ltd.
Isis House, 43 Station Road
Henley-on-Thames
Oxfordshire RG9 1AT, UK
United Kingdom
Tel : +44 1491 414333
Slovenija
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Nemčija
Tel : +49 6074 812160
Ísland
Swedish Orphan A/S,
c/o Ísfarm ehf., Lynghálsi 13,
IS-110 Reykjavik
Tel : +354 540 8080
Slovenská republika
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Nemecko
Tel : +49 6074 812160
Italia
Orphan Europe (Italy) Srl
Via Cellini 11
I-20090 Segrate (Milano)
Tel : +39 02 26 95 01 39
Suomi/Finland
Oy swedish Orphan AB
Rajatorpantie 41 C,
FIN-016 40 Vantaa
Puh/Tfn : +358 (0)9 8520 2150
Κύπρος
Orphan Europe SARL
Immeuble “Le Wilson”
70 Avenue du General de Gaulle
F-92 800 Puteaux
Γαλλία
Τηλ: +33 1 47 73 64 58
Sverige
Swedish Orphan AB
Drottninggatan 98,
S-111 60 Stockholm
Tfn : +46(0)8 412 98 00
Latvija
Orphan Europe AB
Banérgatan 37
S-115 22 Stockholm
Zviedrija
Tel : +46 8 545 80 230
United Kingdom
Orphan Europe (UK) Ltd.
Isis House, 43 Station Road
Henley-on-Thames
Oxfordshire RG9 1AT
Tel : +44 (0)1491 414333
20
Lietuva
Orphan Europe AB
Banérgatan 37
S-115 22 Stockholm
Švedija
Tel : +46 8 545 80 230
This leaflet was last approved in
{MM/YYYY}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
http://www.emea.europa.eu/
. There are also links to other websites about rare diseases and treatments.
21
Source: European Medicines Agency
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