DELTYBA 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. Deltyba 50 mg film-coated tablets
   1. What is Deltyba and what is it used for?
   2. What you need to know before you take Deltyba
   3. How to take Deltyba
   4. Possible side effects
   5. How to store Deltyba
   6. Package Contents and Other Information
2. Deltyba 25 mg dispersible tablets
   1. What is Deltyba and what is it used for?
   2. What you need to know before you take Deltyba
   3. How to take Deltyba
   4. Possible side effects
   5. How to store Deltyba
   6. Package Contents and Other Information

Deltyba 50 mg film-coated tablets

delamanid

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Deltyba is and what it is used for
• 2. What you need to know before you take Deltyba
• 3. How to take Deltyba
• 4. Possible side effects
• 5. How to store Deltyba
• 6. Contents of the pack and other information

1. What is Deltyba and what is it used for?

Deltyba contains the active substance delamanid, an antibiotic for the treatment of pulmonary tuberculosis caused by bacteria that are not eradicated by the antibiotics most commonly used to treat tuberculosis.
It must always be taken together with other medicines for the treatment of tuberculosis.
Deltyba is used in adults, adolescents, children and infants weighing at least
10 kg.

2. What you need to know before you take Deltyba

Do not take Deltyba

• if you are allergic to delamanid or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low levels of albumin in your blood.
• if you are taking medicines that strongly increase the activity of a certain liver enzyme called ‘CYP450 3A4’ (e.g. carbamazepine [a medicine used to treat epilepsy and prevent convulsions]).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Deltyba.
Before starting to take Deltyba and during treatment, your doctor may check the electrical activity of your heart using an electrocardiogram (ECG). Your doctor may also
perform a blood test to check the concentration of certain electrolytes (salts) and
proteins important for heart function.
Tell your doctor if you have any of the following conditions:

• if you have reduced levels of albumin, potassium, magnesium or calcium in your blood.
• if you have been told you have heart problems, such as a slow heart rate (bradycardia), or if you have previously had a heart attack (myocardial infarction).
• if you have a condition called congenital long QT syndrome or have a serious heart disease, or problems with your heart rhythm.
• if you have liver disease or severe kidney disease.

Tell your doctor immediately while taking this medicine:

• if the symptoms of tuberculosis reappear or worsen (see section 4. Possible side effects).

Children and adolescents
Deltyba is not suitable for children with a body weight of less than 10 kg as there is insufficient data available in these patients to determine the correct doses.

Other medicines and Deltyba
Tell your doctor if

• you are taking, have recently taken or might take any other medicines.
• if you are taking medicines to treat an irregular heartbeat (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• if you are taking medicines for the treatment of psychosis (e.g. phenothiazines, sertindole, sulpiride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
• if you are taking certain antibacterial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline or pentamidine).
• if you are taking certain triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
• if you are taking certain medicines for the treatment of allergic reactions (e.g. terfenadine, astemizole, mizolastine).
• if you are taking certain medicines for the treatment of malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
• if you are taking any of the following medicines: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), difemanil (used to treat stomach disorders or excessive sweating), probucol (reduces blood cholesterol levels), levomethadil or methadone (used to treat opioid dependence), vinca alkaloids (cancer medicines), or arsenic trioxide (used to treat some types of leukemia).
• If you are taking medicines for the human immunodeficiency virus (HIV) that contain lopinavir/ritonavir or saquinavir. You may be at greater risk of dangerous heart rhythm changes.

Pregnancy and breastfeeding
Deltyba can harm the unborn child. Its use is not normally recommended during pregnancy.
It is important to tell your doctor if you are pregnant, suspect you might be pregnant or are planning a
pregnancy. The doctor will assess the benefits for you against the risks to the baby from taking
Deltyba during pregnancy.
It is not known whether delamanid passes into human breast milk. Breastfeeding is not
recommended during treatment with Deltyba.

Driving and using machines
Deltyba is expected to have a moderate effect on the ability to drive and operate
machinery. If you experience side effects that may impair your concentration and
reaction time, do not drive and do not use machinery.

Deltyba 50 mg film-coated tabletscontains lactose monohydrate.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Deltyba

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
As recommended by your doctor, the recommended dose is:
Adults, adolescents and children with a body weight of 50 kg or more: two film-coated tablets
of 50 mg taken twice a day (morning and evening) for 24 weeks.
Children with a body weight of 30 kg or more, but less than 50 kg: one film-coated tablet of
50 mg twice a day for 24 weeks.
25 mg dispersible tablets.
Your doctor may decide to prescribe the 50 mg film-coated tablets for more than
24 weeks.
The film-coated tablets should be taken during or immediately after meals. Swallow the
tablets with water.

If you take more Deltyba than you should
If you have taken more tablets than your prescribed dose, contact your doctor or the nearest
hospital. Remember to bring the medicine packaging with you, so it is clear which medicine you have taken.

If you forget to take Deltyba
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the
next dose, skip the forgotten dose.
Do not take a double dose to make up for a missed tablet.

If you stop taking Deltyba
DO NOTstop taking the tablets unless your doctor tells you to. Stopping too
early may allow bacteria to recover and become resistant to delamanid.
If you have any questions about 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.

Very common side effects (may affect more than 1 in 10 people) observed
in clinical trials with Deltyba were:

• Decreased appetite
• Disturbed sleep, including nightmares*
• Feeling dizzy
• Feeling unwell (nausea)
• Headache
• Stomach irritation (gastritis)
• Vomiting

*Cases have been reported predominantly in children.

Common side effects (may affect up to 1 in 10 people) observedin clinical
trials with Deltyba were:

• Chest pain
• Reduced thyroid activity (hypothyroidism)
• Heart rhythm defect that predisposes to fainting, dizziness and palpitations (QT prolongation on the electrocardiogram)
• Depression
• Feeling anxious (anxiety)
• Hallucination (seeing, hearing or perceiving something that does not exist)*
• Heart rhythm disturbance (first-degree atrioventricular block)
• Indigestion (dyspepsia)
• Irregular heartbeats (ventricular extrasystoles)
• Muscle weakness
• Muscle spasms
• Numbness, reduced sensitivity in the hands and/or feet (hypoesthesia)
• Awareness of heartbeat (palpitations)
• Increased cortisol levels in the blood
• Tremors (often in the hands)
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that do not exist
• Sore throat

*Cases have been reported predominantly in children.

Uncommon side effects (may affect up to 1 in 100 people) observedin
clinical trials with Deltyba were:

• Lack of energy (lethargy)

Other side effects that have been reported with the use of Deltyba:the frequency cannot be
defined on the basis of the available data

• Paradoxical drug reactions (symptoms of tuberculosis may reappear or new symptoms may appear after initial improvement during treatment)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 Deltyba

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 pack or on the blister
respectively after ‘Scad.’ or ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Deltyba 50 mg film-coated tablets contain

• Each film-coated tablet contains 50 mg of the active ingredient delamanid.
• The other components are hypromellose phthalate, povidone, all-rac-α-tocopherol, microcrystalline cellulose, sodium starch glycolate, calcium carmellose, hydrated colloidal silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).

Description of the appearance of Deltyba 50 mg film-coated tablets and package contents
The film-coated tablets of Deltyba 50 mg are round and yellow in color.
Deltyba is supplied in packs of 48 film-coated tablets in aluminum/aluminum blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Otsuka Novel Products GmbH
Erika-Mann-Straße 21
80636 München
Germany

Tel: +49 (0)89 206020 500
Manufacturer:
R-Pharm Germany GmbH
Heinrich-Mack-Straße 35
89257 Illertissen
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

BE
Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500

LT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

BG
Otsuka Novel Products GmbH
Тел.: +49 (0)89 206020 500

LU
Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500

CZ
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

HU
Otsuka Novel Products GmbH
Tel.: +49 (0)89 206020 500

DK
Otsuka Novel Products GmbH
Tlf: +49 (0)89 206020 500

MT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

DE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

NL
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

EE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

NO
Otsuka Novel Products GmbH
Tlf: +49 (0)89 206020 500

EL
Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500

AT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

ES
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20

PL
Otsuka Novel Products GmbH
Tel.: +49 (0)89 206020 500

FR
Otsuka Pharmaceutical France SAS
Tél. : +33 (0)1 47 08 00 00

PT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

HR
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

RO
Swixx Biopharma S.R.L.
Tel. +40 37 1530 850

IE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

SI
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

IS
Otsuka Novel Products GmbH
Sími: +49 (0)89 206020 500

SK
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

IT
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0)2 00632710

FI
Otsuka Novel Products GmbH
Puh/Tel: +49 (0)89 206020 500

CY
Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500

SE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

LV
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
This medicinal product is subject to additional monitoring. This means that further information may be
required to ensure its safe and effective use.
The European Medicines Agency will review the new information at least annually.
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/. Additionally, links to other websites on rare diseases and related
therapeutic treatments are provided.

Deltyba 25 mg dispersible tablets

delamanid

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Deltyba is and what it is used for
• 2. What you need to know before you take Deltyba
• 3. How to take Deltyba
• 4. Possible side effects
• 5. How to store Deltyba
• 6. Contents of the pack and other information

1. What is Deltyba and what is it used for?

Deltyba contains the active ingredient delamanid, an antibiotic for the treatment of pulmonary tuberculosis caused by bacteria that are not eradicated by the antibiotics most commonly used to treat tuberculosis.
It must always be taken together with other medicines for the treatment of tuberculosis.
Deltyba is used in adults, adolescents, children and infants weighing at least
10 kg.

2. What you need to know before you take Deltyba

Do not take Deltyba

• if you are allergic to delamanid or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low levels of albumin in your blood.
• if you are taking medicines that strongly increase the activity of a certain liver enzyme called ‘CYP450 3A4’ (e.g. carbamazepine [a medicine used to treat epilepsy and prevent seizures]).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Deltyba.
Before starting to take Deltyba and during treatment, your doctor may check the electrical activity of your heart using an electrocardiogram (ECG). The doctor may also
perform a blood test to check the concentration of certain electrolytes (salts) and
proteins important for heart function.
Tell your doctor if you have any of the following conditions:

• if you have reduced levels of albumin, potassium, magnesium or calcium in your blood.
• if you have been told you have heart problems, such as a slow heart rate (bradycardia), or if you have had a heart attack (myocardial infarction) in the past.
• if you have a condition called congenital long QT syndrome or have a serious heart disease, or problems with your heart rhythm.
• if you have a liver disease or a severe kidney disease.

Tell your doctor immediately while taking this medicine:

• if the symptoms of tuberculosis reappear or worsen (see section 4. Possible side effects).

Children and adolescents
Deltyba is not suitable for children with a body weight of less than 10 kg because there is insufficient data available in these patients to determine the correct doses.

Other medicines and Deltyba
Tell your doctor if

• you are taking, have recently taken or might take any other medicines.
• if you are taking medicines to treat an irregular heartbeat (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• if you are taking medicines for the treatment of psychosis (e.g. phenothiazines, sertindole, sulpiride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
• if you are taking certain antibacterial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline or pentamidine).
• if you are taking certain triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
• if you are taking certain medicines for the treatment of allergies (e.g. terfenadine, astemizole, mizolastine).
• if you are taking certain medicines for the treatment of malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
• if you are taking any of the following medicines: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), difemanil (used to treat stomach disorders or excessive sweating), probucol (reduces blood cholesterol levels), levomethadyl or methadone (used to treat opioid dependence), vinca alkaloids (cancer medicines), or arsenic trioxide (used to treat some types of leukemia).
• If you are taking medicines for the human immunodeficiency virus (HIV) that contain lopinavir/ritonavir or saquinavir. You may be at greater risk of dangerous heart rhythm changes.

Pregnancy and breastfeeding
Deltyba can harm the unborn child. It is not normally recommended during pregnancy.
It is important to tell your doctor if you are pregnant, suspect you might be pregnant or are planning a
pregnancy. The doctor will assess the benefits for you against the risks for the baby with the use of
Deltyba during pregnancy.
It is not known whether delamanid passes into human breast milk. Breastfeeding is not
recommended during treatment with Deltyba.

Driving and operating machinery
Deltyba is expected to have a moderate effect on the ability to drive and operate
machinery. If you experience side effects that may impair your ability to concentrate and
react, do not drive and do not operate machinery.

3. How to take Deltyba

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
As recommended by your doctor, the recommended dose is:
Children with a body weight of 20 kg or more, but less than 30 kg: two dispersible tablets
of 25 mg in the morning and one dispersible tablet of 25 mg in the evening for 24 weeks.
Children with a body weight of 10 kg or more, but less than 20 kg: one dispersible tablet
of 25 mg in the morning and one dispersible tablet of 25 mg in the evening for 24 weeks.
Deltyba 50 mg film-coated tablets.
Dispersible tablets must be taken during or immediately after meals.
Place the dispersible tablet/dispersible tablets of 25 mg in a glass or cup.
Pour 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet into the
glass or cup. Wait for the dispersible tablet/dispersible tablets to dissolve/dissolve completely (approximately 30 seconds) and rotate the glass or cup slowly to
obtain a uniform suspension. The resulting whitish suspension must be ingested
immediately. Then, another 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet should be added to the glass or cup, rotating it/rotating it slowly to ensure the dispersion of any remaining suspension, and the resulting suspension should also be ingested
immediately.

If you take more Deltyba than you should
If you have taken more tablets than your prescribed dose, contact your doctor or the nearest hospital. Remember
to bring the medicine packaging with you, so it is clear which medicine you have taken.

If you forget to take Deltyba
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the
next dose, skip the forgotten dose.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Deltyba
DO NOTstop taking the tablets unless your doctor tells you to. Stopping too
early may allow bacteria to recover and become resistant to delamanid.
If you have any doubts about 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.

Very common side effects (may affect more than 1 in 10 people) observed
in clinical trials with Deltyba were:

• Reduced appetite
• Disturbed sleep, including nightmares*
• Feeling dizzy
• Feeling unwell (nausea)
• Headache
• Stomach irritation (gastritis)
• Vomiting

*Cases have been reported predominantly in children.

Common side effects (may affect up to 1 in 10 people) observedin clinical
trials with Deltyba were:

• Chest pain
• Reduced thyroid activity (hypothyroidism)
• Heart rhythm defect that predisposes to fainting, dizziness and palpitations (QT prolongation on the electrocardiogram)
• Depression
• Feeling anxious (anxiety)
• Hallucination (seeing, hearing or perceiving something that does not exist)*
• Heart rhythm disorder (first-degree atrioventricular block)
• Indigestion (dyspepsia)
• Irregular heartbeats (ventricular extrasystoles)
• Muscle weakness
• Muscle spasms
• Numbness, reduced sensitivity in the hands and/or feet (hypoesthesia)
• Awareness of heartbeat (palpitations)
• Increased cortisol levels in the blood
• Tremors (often in the hands)
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that do not exist
• Sore throat

*Cases have been reported predominantly in children.

Uncommon side effects (may affect up to 1 in 100 people) observedin
clinical trials with Deltyba were:

• Lack of energy (lethargy)

Other side effects that have been reported with the use of Deltyba:the frequency cannot be
defined based on available data

• Paradoxical drug reactions (tuberculosis symptoms may reappear or new symptoms may appear after initial improvement during treatment)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Deltyba

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 package or blister
respectively after ‘Scad.’ or ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Deltyba 25mg dispersible tablets contain

• Each dispersible tablet contains 25 mg of the active substance delamanid.
• The other ingredients are hypromellose phthalate, povidone (K-25), all-rac-α-tocopherol, mannitol, crospovidone, sucralose, hydrated colloidal silica, cherry flavour Micron OT-22685, calcium stearate.

Description of the appearance of Deltyba 25mg dispersible tablets and package contents
Deltyba 25 mg dispersible tablets are round and range in colour from white to off-white.
Deltyba is supplied in packs of 48 dispersible tablets in aluminium/aluminium blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Otsuka Novel Products GmbH
Erika-Mann-Straße 21
80636 München
Germany

Tel: +49 (0)89 206020 500
Manufacturer:
R-Pharm Germany GmbH
Heinrich-Mack-Straße 35
89257 Illertissen
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

BE
Otsuka Novel Products GmbH
Tel/Tél: +49 (0)89 206020 500

LT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

BG
Otsuka Novel Products GmbH
Тел.: +49 (0)89 206020 500

LU
Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500

CZ
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

HU
Otsuka Novel Products GmbH
Tel.: +49 (0)89 206020 500

DK
Otsuka Novel Products GmbH
Tlf: +49 (0)89 206020 500

MT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

DE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

NL
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

EE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

NO
Otsuka Novel Products GmbH
Tlf: +49 (0)89 206020 500

EL
Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500

AT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

ES
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20

PL
Otsuka Novel Products GmbH
Tel.: +49 (0)89 206020 500

FR
Otsuka Pharmaceutical France SAS
Tél. : +33 (0)1 47 08 00 00

PT
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

HR
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

RO
Swixx Biopharma S.R.L.
Tel. +40 37 1530 850

IE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

SI
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

IS
Otsuka Novel Products GmbH
Sími: +49 (0)89 206020 500

SK
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

IT
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0)2 00632710

FI
Otsuka Novel Products GmbH
Puh/Tel: +49 (0)89 206020 500

CY
Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500

SE
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

LV
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
An authorisation has been granted to this medicinal product under “exceptional circumstances”. This means that
further data on this medicinal product must be provided.
The European Medicines Agency will review the new information at least annually on this
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ . Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.