ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Carbaglu 200 mg dispersible tablets
2.
Each tablet contains 200 mg of carglumic acid.
For a full list of excipients, see section 6.1
3.
Dispersible tablet
The tablets are white and elongated with three score marks and engraved on one side.
The tablet can be divided into equal halves.
4.
Treatment of hyperammonaemia due to N-acetylglutamate synthase deficiency.
Carbaglu treatment should be initiated under the supervision of a physician experienced in the
treatment of metabolic disorders.
Based on clinical experience, the treatment may be started as early as the first day of life.
The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
It should then be adjusted individually in order to maintain normal ammonia plasma levels (see
section 4.4).
In the long term, it may not be necessary to increase the dose according to body weight as long as
adequate metabolic control is achieved; daily doses range from 10 mg/kg to 100 mg/kg.
Carglumic acid responsiveness test
It is recommended to test individual responsiveness to carglumic acid before initiating any long term
treatment. As examples
-
In a comatose child, start with a dose of 100 to 250 mg/kg/day and measure ammonia plasma
concentration at least before each administration; it should normalise within a few hours after
starting Carbaglu.
-
In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day
for 3 days with a constant protein intake and perform repeated determinations of ammonia
plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain
normal ammonia plasma levels.
Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily
dose into two to four doses to be given before meals or feedings. The breaking of the tablets in halves
allows most of the required posology adjustments. Occasionally, the use of quarter tablets may also be
useful to adjust the posology prescribed by the physician.
The tablets must be dispersed in a minimum of 5-10 ml of water and ingested immediately or
administered by fast push through a syringe via a nasogastric tube.
The suspension has a slightly acidic taste.
2
Hypersensitivity to the active substance or to any of the excipients.
Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
Therapeutic monitoring
Plasma levels of ammonia and amino acids should be maintained within normal limits.
As very few data on the safety of carglumic acid are available, systematic surveillance of liver, renal,
cardiac functions and haematological parameters is recommended.
Nutritional management
Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
No specific interaction studies have been performed.
For carglumic acid no clinical data on exposed pregnancies are available.
Animal studies have revealed minimal developmental toxicity (see section 5.3). Caution should be
exercised when prescribing to pregnant women.
Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be
present in the milk of lactating rats (see section 5.3). Therefore, breast-feeding during the use of
carglumic acid is contraindicated. (see section 4.3).
No studies on the effects on the ability to drive and use machines have been performed.
Clinical experience has been collected in about 170 patient-years.
Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are
defined as: very common (≥ 1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Investigations
Uncommon
: increased transaminases
Skin and subcutaneous tissue
disorders
Common
: increased sweating
In one patient treated with carglumic acid, where the dose was increased up to 750 mg/kg/day,
symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction:
tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and
restlessness. These symptoms resolved once the dose was reduced.
3
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05
Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring
activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Carglumic acid has been shown
in vitro
to activate liver carbamoyl phosphate synthetase. Despite a
lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate,
carglumic acid has been shown
in vivo
to stimulate carbamoyl phosphate synthetase and to be much
more effective than N-acetylglutamate in protecting against ammonia intoxication in rats. This could
be explained by the following observations:
i) The mitochondrial membrane is more readily permeable for carglumic acid than for N-
acetylglutamate
ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in
the cytosol.
Other studies have been conducted in rats under different experimental conditions leading to increased
ammonia availability (starvation, protein-free or high-protein diet). Carglumic acid was shown to
decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content
of carbamoyl phosphate synthetase activators was significantly increased.
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid
normalisation of plasma ammonia levels, usually within 24 hours. When the treatment was instituted
before any permanent brain damage, patients exhibited normal growth and psychomotor development.
5.2
Pharmacokinetic properties
The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both
radiolabelled and unlabelled product.
Absorption
After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated
to be absorbed. At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration
peaked at 2.6 µg/ml (median; range 1.8-4.8) after 3 hours (median; range 2-4).
Distribution
The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours
after administration followed by a slow phase (terminal half life up to 28 hours).
Diffusion into erythrocytes is non existent. Protein binding has not been determined.
Metabolism
A proportion of carglumic acid is metabolised. It is suggested that depending on its activity, the
intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a
variable extent of metabolism of the molecule. One metabolite that has been identified in the faeces is
glutamic acid. Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline
(half-life around 100 hours).
The end product of carglumic acid metabolism is carbon dioxide, which is eliminated through the
lungs.
Elimination
After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the urine
and up to 60% in the faeces.
Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants
to adolescents, treated with various daily doses (7 – 122 mg/kg/day). Their range was consistent with
4
those measured in healthy adults, even in newborn infants. Whatever the daily dose, they were slowly
declining over 15 hours to levels around 100 ng/ml.
5.3 Preclinical safety data
Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500,
1000 mg/kg had no statistically significant effect on respiration, central nervous system and
cardiovascular system.
Carbaglu showed no significant mutagenic activity in a battery of genotoxicity tests performed
in vitro
(Ames test, human lymphocyte metaphase analysis) and
in vivo
(micronucleus test in rat).
Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not induce
any mortality or abnormal clinical signs in adult rats. In newborn rats receiving daily carglumic acid
by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the
No Observed Effect Level (NOEL) was established at 500 mg/kg/day and the No Observed Adverse
Effect Level (NOAEL) was established at 1000 mg/kg/day.
No adverse effects have been observed on male or female fertility. In rats and rabbits no evidence has
been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses leading to fifty
times exposure as compared to humans in rats and seven times in rabbits. Carglumic acid is secreted in
the milk of lactating rats and although developmental parameters were unaffected, there were some
effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and
a higher mortality of pups from dams treated with 2000/kg/day, a dose that caused maternotoxicity.
The maternal systemic exposures after 500 and 2000 mg/kg/day were twenty five times and seventy
times the expected human exposure.
No carcinogenicity study has been conducted with carglumic acid.
6.
6.1 List of excipients
Microcrystalline cellulose
sodium laurilsulfate
hypromellose
croscarmellose sodium
silica colloidal anhydrous
sodium stearyl fumarate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
30 months
After first opening of the tablet container: 1 month
5
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C)
After first opening of the tablet container:
Do not refrigerate.
Do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
6.5 Nature and contents of container
5-, 15- or 60- polypropylene tablet containers closed by a polyethylene cap with a desiccant unit.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7.
Orphan Europe SARL
Immeuble “Le Wilson”
70 avenue du Général de Gaulle
F-92800 Puteaux
France
8.
EU/1/02/246/001 (15 dispersible tablets)
EU/1/02/246/002 (60 dispersible tablets)
EU/1/02/246/003 (5 dispersible tablets)
9.
24 January 2003
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA) http://www.emea.europa.eu/.
6
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 SARL, 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.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS
1.
Carbaglu 200 mg dispersible tablets
Carglumic acid
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 200 mg of carglumic acid.
3.
LIST OF EXCIPIENTS
4.
5 dispersible tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
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 {MM/YYYY}
Discard one month after first opening.
Opened:
11
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2°C – 8°C)
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
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 Général de Gaulle
F-92800 Puteaux
France
EU/1/02/246/003
13. MANUFACTURER’S BATCH NUMBER
Batch {number}
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Carbaglu 200 mg
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS
1.
Carbaglu 200 mg dispersible tablets
Carglumic acid
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 200 mg of carglumic acid.
3.
LIST OF EXCIPIENTS
4.
15 dispersible tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
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 {MM/YYYY}
Discard one month after first opening.
Opened:
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2°C – 8°C)
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
13
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 Général de Gaulle
F-92800 Puteaux
France
EU/1/02/246/001
13. MANUFACTURER’S BATCH NUMBER
Batch {number}
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Carbaglu 200 mg
14
1.
Carbaglu 200 mg dispersible tablets
Carglumic acid
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 200 mg of carglumic acid.
3.
LIST OF EXCIPIENTS
4.
60 dispersible tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
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 {MM/YYYY}
Discard one month after first opening.
Opened:
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2°C – 8°C)
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
15
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 Général de Gaulle
F-92800 Puteaux
France
EU/1/02/246/002
13. MANUFACTURER’S BATCH NUMBER
Batch {number}
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Carbaglu 200 mg
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:INFORMATION FOR THE USER
Carbaglu 200 mg dispesible tablets
Carglumic acid
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your pharmacist.
-
This medicine has been prescribed for you personally and you should 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 Carbaglu is and what it is used for
2.
Before you take Carbaglu
3.
How to take Carbaglu
4.
Possible side effects
5
How to store Carbaglu
6.
Further information
1.
WHAT CARBAGLU IS AND WHAT IT IS USED FOR
Carbaglu can help eliminating excess of hyperammonaemia (elevated ammonia level in the blood),
due to the lack of a specific liver enzyme N- acetylglutamate synthase. Patients with this rare disorder
are not able to eliminate nitrogen waste, which builds up after eating protein. Nitrogen waste is in the
form of ammonia, which is especially toxic for the brain and leads, in severe cases, to reduced levels
of consciousness and to coma.
This disorder will persist during the entire life time of the patient and therefore the need for this
treatment is lifelong.
2.
BEFORE YOU TAKE CARBAGLU
Do not take Carbaglu:
Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other
ingredients of Carbaglu.
Do not take Carbaglu during breast-feeding
Take special care with Carbaglu:
Carbaglu treatment should be initiated under the supervision of a physician experienced in the
treatment of metabolic disorders.
Your doctor will test your individual responsiveness to carglumic acid before initiating any long term
treatment.
The dose should be adjusted individually in order to maintain normal ammonia plasma levels.
Your doctor may prescribe supplemental arginine or restrict your protein intake.
In order to follow-up your condition and your treatment, your doctor may examine your liver, your
kidneys, your heart and your blood on a regular basis.
18
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription
Taking Carbaglu with food and drink
Carbaglu must be taken orally before meals or feedings.
The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately. The
suspension has a slightly acidic taste.
Pregnancy and Breast-feeding
The effects of Carbaglu on pregnancy and the unborn child are not known. Please consult your doctor
for advice if you are pregnant or planning to become pregnant.
The excretion of carglumic acid into breast milk has not been studied in women. Nevertheless, as
carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects
for their fed pups, you should not breast feed your baby if you are taking Carbaglu.
Driving and using machines
Effects on the ability to drive and use machines are not known.
3.
HOW TO TAKE CARBAGLU
Always take Carbaglu exactly as your doctor has instructed you. You should check with your doctor
or pharmacist if you are unsure.
The usual dose:
-
the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of
250 mg per kilogram of body weight (for example, if you weight 10kg, you should take 1g per
day, or 5 tablets),
-
in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body
weight.
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in
your blood.
When the patient is in hyperammonaemic coma, Carbaglu is administered by fast push through a
syringe via the tube set up and used to feed you..
If you take more Carbaglu than you should:
Ask your doctor or pharmacist for advice.
If you forget to take Carbaglu:
Do not take a double dose to make up for forgotten individual doses.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Carbaglu can have side effects.
The following side effects were reported as follows: very common (occurring in at least one in 10
patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one
19
in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one
in 100,000 patients).
•
Common:
increased sweating
•
Uncommon
: increased transaminases
If you notice any side effects, please inform your doctor or pharmacist.
5.
HOW TO STORE CARBAGLU
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the tablet container.
Store in a refrigerator (2°C – 8°C)
After first opening of the container: do not refrigerate, do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
Write the date of opening on the tablet container. Discard 1 month after first opening.
6.
FURTHER INFORMATION
Carbaglu 200 mg dispersible tablets
Carglumic acid
-
The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
-
The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose,
croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate.
Marketing Authorisation Holder and Manufacturer
Orphan Europe SARL
Immeuble “Le Wilson”
70 avenue du Général de Gaulle
F-92800 Puteaux
France
Tel: + 33 1 4773 6458
Fax: + 33 1 4900 1800
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 laan 48 bus 3
BE-1780 Wemmel (Brussels)
Tel: +32 2 46101 36
Luxembourg/Luxemburg
Orphan Europe Benelux
Koning Albert I laan 48 bus 3
BE-1780 Wemmel(Brussels)
Belgique/Belgien
Tel: +32 2 46101 36
България
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
Magyarország
Orphan Europe (Germany) GmbH
20
D-63128 Dietzenbach
Германия
Teл.: + 49 6074 812160
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 Général de Gaulle
F-92800 Puteaux
Franza
Tél : +33 1 47 73 64 58
Danmark
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Sverige
Tlf : +46 8 545 80 230
Nederland
Orphan Europe Benelux
Koning Albert I laan 48 bus 3
BE-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
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Sverige
Tlf :+46 8 545 80 230
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 Général de Gaulle
F-92800 Puteaux
Γαλλία
Tél : +33 1 47 73 64 58
Polska
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D - 63128 Dietzenbach
Niemcy
Tel : +49 6074 812160
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 Général de Gaulle
F-92800 Puteaux
Tél : +33 (0)1 47 73 64 58
România
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D-63128 Dietzenbach
Germania
Tel: + 49 6074 812160
21
Ireland
Orphan Europe (UK) Ltd.
Isis House, 43 Station Road
Henley-on-Thames
Oxfordshire RG9 1AT, UK
Tel : +44 1491 414333
Slovenija
Orphan Europe (Germany) GmbH
Max-Planck Str. 6
D - 63128 Dietzenbach
Nemčija
Tel : +49 6074 812160
Ísland
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Svíþjóð
Tel :+46 8 545 80 230
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
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Sverige
Puh/Tel : +46 8 545 80 230
Κύπρος
Orphan Europe SARL
Immeuble “Le Wilson”
70 avenue du Général de Gaulle
F-92800 Puteaux
Γαλλία
Tél : +33 1 47 73 64 58
Sverige
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Tel : +46 (0)8 545 80 230
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
Lietuva
Orphan Europe AB
Banérgatan 37
S – 115 22 Stockholm
Švedija
Tel : +46 8 545 80 230
This leaflet was last approved on
22
Source: European Medicines Agency
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