Qtern

Helstu upplýsingar

  • Heiti vöru:
  • Qtern
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Qtern
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes,
  • Lækningarsvæði:
  • Diabetes Mellitus, Type 2
  • Ábendingar:
  • Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
  • Vörulýsing:
  • Revision: 3

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/004057
  • Leyfisdagur:
  • 14-07-2016
  • EMEA númer:
  • EMEA/H/C/004057
  • Síðasta uppfærsla:
  • 23-05-2019

Opinber matsskýrsla

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/378777/2016

EMEA/H/C/004057

EPAR summary for the public

Qtern

saxagliptin / dapagliflozin

This is a summary of the European public assessment report (EPAR) for Qtern. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Qtern.

For practical information about using Qtern, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Qtern and what is it used for?

Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar)

levels. It contains the active substances saxagliptin and dapagliflozin.

Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with:

metformin and one of the components of Qtern;

a sulphonylurea and one of the components of Qtern;

metformin, a sulphonylurea and one of the components of Qtern.

Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets.

How is Qtern used?

Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with

a prescription. The recommended dose is one tablet taken once a day. For further information, see the

package leaflet.

Qtern

EMA/378777/2016

Page 2/3

How does Qtern work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels

of glucose in the blood or when the body is unable to respond to insulin effectively. This leads to high

levels of glucose in the blood.

Qtern contains two different active substances, which work in different ways:

dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2

(SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being

passed out into the urine. By blocking the action of SGLT2, dapagliflozin causes more glucose to be

removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.

Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;

saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of

incretin hormones in the body. These hormones are released after a meal and stimulate the

pancreas to produce insulin. By increasing levels of incretin hormones in the blood, saxagliptin

stimulates the pancreas to produce more insulin when blood glucose levels are high. Saxagliptin

does not work when the blood glucose is low. Saxagliptin also reduces the amount of glucose made

by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.

Saxagliptin has been authorised in the EU as Onglyza since 2009.

As a result of the action of both active substances, the blood glucose is reduced and this helps to

control type 2 diabetes.

What benefits of Qtern have been shown in studies?

Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3

main studies involving 1,169 adults with type 2 diabetes. The main measure of effectiveness was the

change after 24 weeks of treatment in the level of a substance in the blood called glycosylated

haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The first study included patients whose blood glucose levels were not satisfactorily controlled with

metformin alone. Results showed that when saxagliptin and dapagliflozin were taken together with

metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a

reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with

dapagliflozin and metformin. HbA1c levels were on average around 9% at the start of the study.

The second study included patients whose blood glucose levels were not satisfactorily controlled with

metformin and dapagliflozin. Results showed that adding saxagliptin to treatment with dapagliflozin

and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a

reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with

dapagliflozin and metformin. HbA1c levels were around 8% at the start of the study.

A further study, which included patients not controlled with metformin and saxagliptin, showed that

adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by

0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to

saxagliptin and metformin.

The company also provided studies that were used in the authorisation of Forxiga and Onglyza where

saxagliptin or dapagliflozin were used together with a sulphonylurea.

Qtern

EMA/378777/2016

Page 3/3

What are the risks associated with Qtern?

The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper

respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea,

hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with Qtern, see

the package leaflet.

Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of

the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.

Why is Qtern approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Qtern’s benefits

are greater than its risks and recommended that it be approved for use in the EU.

The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken

as separate tablets. The CHMP also considered Qtern to be effective at controlling blood glucose levels

when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or

dapagliflozin. Although both components of Qtern contribute to lowering blood glucose levels, the

effects of each may vary in different patients. The CHMP therefore considered that Qtern should only

be used in patients already receiving at least one component to avoid over-treatment and so that the

value of each component can be judged individually.

On the basis of previous studies with the individual components of Qtern used together with a

sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.

Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2

and DDP-4 inhibitors.

What measures are being taken to ensure the safe and effective use of

Qtern?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Qtern have been included in the summary of product characteristics and the

package leaflet.

Other information about Qtern

The European Commission granted a marketing authorisation valid throughout the European Union for

Qtern on 15 July 2016.

The full EPAR for Qtern can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Qtern, read

the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Qtern 5 mg/10 mg film-coated tablets

saxagliptin/dapagliflozin

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, pharmacist or nurse.

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:

What Qtern is and what it is used for

What you need to know before you take Qtern

How to take Qtern

Possible side effects

How to store Qtern

Contents of the pack and other information

1.

What Qtern is and what it is used for

Qtern contains the active substances saxagliptin and dapagliflozin. Each belongs to a group of

medicines called “oral anti-diabetics”.

This medicine is taken by mouth for diabetes.

This medicine is used if your diabetes cannot be controlled with other oral diabetes medicines,

along with diet and exercise.

Qtern is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years

and older). “Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older. If

you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use

the insulin it produces properly. This leads to a high level of sugar in your blood. The two active

substances in Qtern work in different ways to help control the level of sugar in your blood and remove

excess sugar from your body via your urine.

It is important to continue to follow the advice on diet and exercise given to you by your doctor,

pharmacist or nurse.

2.

What you need to know before you take Qtern

Do not take Qtern:

if you are allergic to saxagliptin, dapagliflozin or any of the other ingredients of this medicine

(listed in section 6).

if you have had a serious allergic reaction to any other similar medicines (for example DPP-4

inhibitors like sitagliptin, linagliptin, alogliptin, or SGLT2 inhibitors like canagliflozin,

empagliflozin) that you take to control your blood sugar.

Do not take Qtern if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist,

or nurse before taking Qtern.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Qtern, and during treatment:

if you have “type 1 diabetes” (the type that usually starts when you are young, and your body

does not produce any insulin).

if you have or have had a disease of the pancreas.

if you have moderate or severe kidney problems.

if you have a condition that reduces your body’s ability to fight infections, such as a disease like

AIDS or from medicines that you might take after an organ transplant.

if you have moderate or severe liver problem.

if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst,

fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath,

a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a

doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic

ketoacidosis” – a rare but serious, sometimes life-threatening problem you can get with diabetes

because of increased levels of “ketone bodies” in your urine or blood, seen in tests. The risk of

developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol

consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to

major surgery or serious illness.

if you have or have had a serious hypersensitivity reaction or is suspected.

if you have a history of serious heart disease.

if you suffer from heart failure or you have other risk factors for developing heart failure such as

problems with your kidneys. Your doctor will advise you of the signs and symptoms of heart

failure. Symptoms can include, but are not limited to, increasing shortness of breath, rapid

increase in weight and swelling of the feet (pedal oedema). You should call your doctor,

pharmacist or nurse immediately if you experience any of these symptoms.

if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of

low blood pressure (hypotension). For more information, see section “Other medicines and

Qtern” below.

if you have very high levels of sugar in your blood which may make you dehydrated (lose too

much body fluid). Possible signs of dehydration are listed at the top of section 4. Tell your

doctor before you start taking Qtern if you have any of these signs.

if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or

drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Qtern

until you recover to prevent dehydration.

if you often get infections of the urinary tract or have a serious infection of the urinary tract,

including urosepsis or pyelonephritis, which can cause fever and/or chills, burning sensation

when passing water (urinating), blood in urine, pain in your back or side. You should call your

doctor, pharmacist or nurse immediately if you experience any of these symptoms.

if you are 75 years old or older.

if you are taking a medicine to lower your blood sugar, such as insulin or sulphonylureas.

if you are taking another medicine for diabetes that contains “pioglitazone”.

if you have an increase in the amount of red blood cells in your blood, seen in tests.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before

taking Qtern.

Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes.

Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4). You

are advised to follow the recommendations for skin care that you are given by your doctor or nurse.

Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice

regarding foot care given by your health care professional.

Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness,

redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling

generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening

infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue

under the skin. Fournier’s gangrene has to be treated immediately.

Kidney function

Your kidneys should be checked before you start taking and whilst you are on this medicine.

Urine tests

Because of how Qtern works, your urine will test positive for sugar while you are on this medicine.

Children and adolescents

Qtern is not recommended for children and adolescents under 18 years of age, because it has not been

studied in these patients.

Other medicines and Qtern

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Especially tell your doctor:

if you are taking a medicine used to increase the amount of water you pass out of the body

(diuretic). Your doctor may ask you to stop taking Qtern. Possible signs of losing too much fluid

from your body are listed at the top of section 4.

if you are using medicines containing any of the following active substances:

Carbamazepine,

phenobarbital or phenytoin.

These may be used to control fits (seizures) or

chronic pain.

Dexamethasone – a steroid medicine. This may be used to treat inflammation in different

body parts and organs.

Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Ketoconazole. This may be used to treat fungal infections.

Diltiazem. This is a medicine used to treat angina (chest pain) and lower blood pressure.

If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine. Qtern is not recommended during

pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant. Talk to

your doctor about the best way to control your blood sugar while you are pregnant.

You should not use Qtern if you are breast-feeding. It is not known if this medicine passes into human

breast milk. Talk to your doctor if you would like to or are breast-feeding before taking this medicine.

Driving and using machines

Qtern is not expected to affect you being able to drive a car or use any tools or machines. If you feel

dizzy while taking Qtern, do not drive or use any tools or machines. Taking this medicine can cause

blood sugar levels to fall too low (hypoglycaemia), which may cause symptoms such as shaking,

sweating and change in vision, and may affect your ability to drive and use machines.

Qtern contains lactose

Qtern contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance

to some sugars, contact your doctor before taking this medicine.

3.

How to take Qtern

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or

nurse if you are not sure.

How much to take

The recommended dose is one tablet a day.

Taking this medicine

Swallow the tablet whole with half a glass of water.

You can take your tablet with or without food.

You can take the tablet at any time of the day. However, try to take it at the same time each day.

This will help you to remember to take it.

Your doctor may prescribe other medicines to lower the amount of sugar in your blood. Remember to

take other medicine(s) as your doctor has told you. This will help get the best results for your health.

Diet and exercise

To control your diabetes, you still need to keep to diet and exercise, even when you are taking this

medicine. So it is important to keep following the advice about diet and exercise from your doctor,

pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to

follow it while you are taking Qtern.

If you take more Qtern than you should

If you take more Qtern tablets than you should, talk to a doctor or go to a hospital straight away. Take

the medicine pack with you.

If you forget to take Qtern

What to do if you forget to take a tablet.

If it is less than 12 hours since you should have taken your dose, take a dose of Qtern as soon as

you remember. Then take your next dose at the usual time.

If it is more than 12 hours since you should have taken your dose, skip the missed dose. Then

take your next dose at the usual time.

Do not take a double dose of Qtern to make up for a forgotten dose.

If you stop taking Qtern

Do not stop taking Qtern without talking to your doctor first. Your blood sugar may increase without

this medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms need immediate medical attention:

Stop taking Qtern and see a doctor straight away if you notice any of the following serious side

effects:

Symptoms of a serious allergic reaction seen rarely, (may affect up to 1 in 1,000 people), which

may include:

Rash

Raised red patches on your skin (hives)

Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or

swallowing.

Your doctor

may prescribe a medicine to treat

your

allergic reaction and a different

medicine for your diabetes.

Pancreatitis, seen uncommonly (may affect up to 1 in 100 people): severe and persistent pain in

the abdomen (stomach area) which might reach through to your back, as well as nausea and

vomiting, as it could be a sign of an inflamed pancreas.

Dehydration, (loss of too much fluid from your body), seen uncommonly (may affect up to

1 in 100 people).

These are signs of dehydration:

- very dry or sticky mouth, feeling very thirsty

- feeling very sleepy or tired

- passing little or no water (urine)

- fast heart beat.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people).

These are signs of a severe infection of the urinary tract:

- fever and/or chills

- burning sensation when passing water (urinating)

- pain in your back or side.

Although uncommon, if you see blood in your urine, tell your doctor immediately.

Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in

10 people) if used with other diabetes medicines known to cause hypoglycaemia.

These are the signs of low blood sugar:

- shaking, sweating, feeling very anxious, fast heart beat

- feeling hungry, headache, change in vision

- a change in your mood or feeling confused.

Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the

signs above.

Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

- increased levels of “ketone bodies” in your urine or blood

- rapid weight loss

- feeling sick or being sick

- stomach pain

- excessive thirst

- fast and deep breathing

- confusion

- unusual sleepiness or tiredness

- a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to

your urine or sweat.

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or

permanently stop your treatment with Qtern.

Necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the

genitals or the area between the genitals and the anus.

Stop taking Qtern and see a doctor or nurse straight away, if you notice any of the serious side effects

above.

Other side effects when taking Qtern alone or in combination with metformin:

Common

genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual

discharge or odour)

back pain

passing more water (urine) than usual or needing to pass water more often

changes in the amount of cholesterol or fats in your blood (shown in tests)

increases in the amount of red blood cells in your blood (shown in tests)

decreases in creatinine renal clearance (shown in tests)

dizziness

tiredness

stomach ache

severe joint pain (arthralgia)

infection of the upper chest or lungs

infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes

(sinusitis)

inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat)

stomach ache and indigestion (dyspepsia)

nausea

diarrhoea

inflamed stomach or gut usually caused by an infection (gastroenteritis)

headache, muscle pain (myalgia)

vomiting, inflammation of the stomach (gastritis)

changes in laboratory tests (for example creatinine renal clearance decreased or haematocrit

increased).

rash

Uncommon

thirst

constipation

awakening from sleep at night to pass urine

dry mouth

weight decreased

increases in creatinine or urea (shown in laboratory blood tests)

decrease in kidney function

skin rash that may include raised bumps, skin irritation, or unpleasant itchiness

difficulties in getting or maintaining an erection (erectile dysfunction).

fungal infection

hypersensitivity reactions

itching in the genital area (pruritus genital or vulvovaginal pruritus) or discomfort while

urinating.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Qtern

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 blister and carton 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 to protect the environment.

6.

Contents of the pack and other information

What Qtern contains

The active substances are saxagliptin and dapagliflozin.

Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and

dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

The other ingredients are:

tablet core: microcrystalline cellulose (E460i), croscarmellose sodium (E468), anhydrous

lactose (see section 2 ‘Qtern contains lactose’), magnesium stearate (E470b), dental type silica

(E551).

film-coating: polyvinyl alcohol (E1203), macrogol 3350, titanium dioxide (E171), talc

(E553b), yellow iron oxide (E172), red iron oxide (E172).

printing ink: shellac, indigo carmine aluminium lake (E132).

What Qtern looks like and contents of the pack

Qtern 5 mg/10 mg film-coated tablets are light brown to brown, biconvex, round, film-coated tablets,

with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.

Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated

tablets in calendar blisters and 30 film-coated tablets in blister.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

България

АстраЗенека България ЕООД

Тел.: +359 2 4455000

Luxembourg/Luxemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Danmark

Malta

AstraZeneca A/S

Tlf: +45 43 66 64 62

Associated Drug Co. Ltd

Tel: +356 2277 8000

Deutschland

AstraZeneca GmbH

Tel: +49 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222

Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Ελλάδα

AstraZeneca A.E.

Τηλ: +30 2 106871500

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Italia

AstraZeneca S.p.A.

Tel: +39 02 9801 1

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Κύπρος

Αλέκτωρ Φαρµακευτική Λτδ

Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

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