Tasigna
nilotinib
nilotinib
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Tasigna is and what it is used for
What you need to know before you take Tasigna
How to take Tasigna
Possible side effects
How to store Tasigna
Contents of the pack and other information
Tasigna is a medicine containing an active substance called nilotinib.
Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many abnormal white blood cells.
Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment including imatinib. It is also used in adult and paediatric patients who experienced serious side effects with previous treatment and are not able to continue taking it.
In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells. Tasigna blocks this signal, and thus stops the production of these cells.
Regular tests, including blood tests, will be performed during treatment. These tests will monitor:
the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see how Tasigna is tolerated.
pancreas and liver function in the body to see how Tasigna is tolerated.
the electrolytes in the body (potassium, magnesium). These are important in the functioning of the heart.
the level of sugar and fats in the blood.
The heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an “ECG”).
Your doctor will regularly evaluate your treatment and decide whether you should continue to take Tasigna. If you are told to discontinue this medicine, your doctor will continue to monitor your CML and may tell you to re-start Tasigna if your condition indicates that this is necessary.
If you have any questions about how Tasigna works or why it has been prescribed for you or your child, ask your doctor.
Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, tell your doctor before taking Tasigna.
Talk to your doctor or pharmacist before taking Tasigna:
if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina), problems with the blood supply to your brain (stroke) or problems with the blood flow to your
leg (claudication) or if you have risk factors for cardiovascular disease such as high blood
pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid disorders).
if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the
QT interval”.
if you are being treated with medicines that lower your blood cholesterol (statins), or affect the heartbeat (anti-arrhythmics) or the liver (see Other medicines and Tasigna).
if you suffer from lack of potassium or magnesium.
if you have a liver or pancreas disorder.
if you have symptoms such as easy bruising, feeling tired or short of breath or have experienced repeated infections.
if you have had a surgical procedure involving the removal of the entire stomach (total
gastrectomy).
if you have ever had or might now have a hepatitis B infection. This is because Tasigna could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be
carefully checked by their doctor for signs of this infection before treatment is started.
If any of these apply to you or your child, tell your doctor.
During treatment with Tasigna
if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine, tell your doctor immediately as this may be a sign of a serious heart condition. Prolongation of the QT interval or an irregular heart beat may lead to sudden death. Uncommon cases of sudden death have been reported in patients taking Tasigna.
if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden changes in your thinking or level of alertness, tell your doctor immediately as this may be a sign of a fast breakdown of cancer cells called tumour lysis syndrome. Rare cases of tumour lysis syndrome have been reported in patients treated with Tasigna.
if you develop chest pain or discomfort, numbness or weakness, problems with walking or with your speech, pain, discolouration or a cool feeling in a limb, tell your doctor immediately as
this may be a sign of a cardiovascular event. Serious cardiovascular events including problems
with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been
reported in patients taking Tasigna. Your doctor should assess the level of fats (lipids) and sugar
in your blood before initiating treatment with Tasigna and during treatment.
if you develop swelling of the feet or hands, generalised swelling or rapid weight gain tell your doctor as these may be signs of severe fluid retention. Uncommon cases of severe fluid
retention have been reported in patients treated with Tasigna.
If you are the parent of a child who is being treated with Tasigna, tell the doctor if any of the above conditions apply to your child.
Tasigna is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children below 2 years of age. There is no experience with the use of Tasigna in newly diagnosed children below 10 years of age and limited experience in patients below 6 years of age who are no longer benefiting from previous treatment for CML.
Some children and adolescents taking Tasigna may have slower than normal growth. The doctor will monitor growth at regular visits.
Tasigna may interfere with some other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes in particular:
anti-arrhythmics – used to treat irregular heart beat;
chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that may have an unwanted effect on the electrical activity of the heart;
ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin – used to treat
infections;
ritonavir – a medicine from the class “ antiproteases” used to treat HIV;
carbamazepine, phenobarbital, phenytoin – used to treat epilepsy;
rifampicin – used to treat tuberculosis;
St. John’s Wort – a herbal product used to treat depression and other conditions (also known as
Hypericum perforatum);
midazolam – used to relieve anxiety before surgery;
alfentanil and fentanyl – used to treat pain and as a sedative before or during surgery or medical procedures;
cyclosporine, sirolimus and tacrolimus – medicines that suppress the “self-defence” ability of
the body and fight infections and are commonly used to prevent the rejection of transplanted organs such as the liver, heart and kidney;
dihydroergotamine and ergotamine – used to treat dementia;
lovastatin, simvastatin – used to treat high level of fats in blood;
warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses);
astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine).
These medicines should be avoided during your treatment with Tasigna. If you are taking any of these, your doctor might prescribe other alternative medicines.
If you are taking a statin (a type of medicine to lower your blood cholesterol), talk to your doctor or pharmacist. If used with certain statins, Tasigna may increase the risk of statin-related muscle problems, which on rare occasions can lead to serious muscle breakdown (rhabdomyolysis) resulting in kidney damage.
In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines against heartburn. These medicines need to be taken separately from Tasigna:
H2 blockers, which decrease the production of acid in the stomach. H2 blockers should be taken approximately 10 hours before and approximately 2 hours after you take Tasigna;
antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone, which neutralise high acidity in the stomach. These antacids should be taken approximately
2 hours before or approximately 2 hours after you take Tasigna.
You should also tell your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not taken previously during Tasigna treatment.
grapefruit. It may increase the amount of Tasigna in the blood, possibly to a harmful level.
medicine during your pregnancy.
last dose. Tell your doctor if you are 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.
If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive or use any tools or machines after taking this medicine, you should refrain from these activities until the effect has disappeared.
This medicine contains lactose (also known as 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults
Use in children and adolescents
The dose given to your child will depend on your child’s body weight and height. The doctor will calculate the correct dose to use and tell you which and how many capsules of Tasigna to give to your child. The total daily dose you give to your child must not exceed 800 mg.
Your doctor may prescribe a lower dose depending on how you respond to treatment.
Tasigna can be used by people aged 65 years and over at the same dose as for other adults.
Take the hard capsules:
twice a day (approximately every 12 hours);
at least 2 hours after any food;
then wait 1 hour before eating again.
If you have questions about when to take this medicine, talk to your doctor or pharmacist. Taking Tasigna at the same time each day will help you remember when to take your hard capsules.
Swallow the hard capsules whole with water.
Do not take any food together with the hard capsules.
Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately. Do not use more than one teaspoon of apple sauce for each hard capsule and do not use any food other than apple sauce.
Continue taking Tasigna every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired
effect.
Your doctor may consider discontinuing your treatment with Tasigna based on specific criteria. If you have questions about how long to take Tasigna, talk to your doctor.
If you have taken more Tasigna than you should have, or if someone else accidentally takes your hard capsules, contact a doctor or hospital for advice straight away. Show them the pack of hard capsules and this package leaflet. Medical treatment may be necessary.
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a forgotten hard capsule.
Do not stop taking this medicine unless your doctor tells you to do so. Stopping Tasigna without your doctor’s recommendation places you at risk for worsening of your disease which could have
life-threatening consequences. Be sure to discuss with your doctor, nurse, and/or pharmacist if you are
considering stopping Tasigna.
Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue to take this medicine. If you are told to discontinue Tasigna, your doctor will
continue to carefully monitor your CML before, during and after you have discontinued Tasigna and may tell you to re-start Tasigna if your condition indicates that this is necessary.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
signs of musculoskeletal pain: pain in joints and muscles
signs of heart disorders: chest pain or discomfort, high or low blood pressure, irregular heart rhythm (fast or slow), palpitations (sensation of rapid heartbeat), fainting, blue discolouration of
the lips, tongue or skin
signs of artery blockage: pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or not at all and
noticeable changes in colour (blueness or paleness) or temperature (coolness) of the affected
leg, arm, toes or fingers
signs of underactive thyroid gland: weight gain, tiredness, hair loss, muscle weakness, feeling cold
signs of overactive thyroid gland: fast heartbeat, bulging eyes, weight loss, swelling at the front of the neck
signs of kidney or urinary tract disorders: thirst, dry skin, irritability, dark urine, decreased urine output, difficulty and pain when urinating, exaggerated sense of needing to urinate, blood in urine, abnormal urine colour
signs of high blood level of sugar: excessive thirst, high urine output, increased appetite with weight loss, tiredness
signs of vertigo: dizziness or spinning sensation
signs of pancreatitis: severe upper (middle or left) abdominal pain
signs of skin disorders: painful red lumps, skin pain, skin reddening, peeling or blisters
signs of water retention: rapid weight gain, swelling of hands, ankles, feet or face
signs of migraine: severe headache often accompanied by nausea, vomiting and sensitivity to light
signs of blood disorders: fever, easy bruising or unexplained bleeding, severe or frequent
infections, unexplained weakness
signs of clotting within a vein: swelling and pain in one part of the body
signs of nervous system disorders: weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there, changes in eyesight, loss of consciousness, confusion, disorientation, trembling, sensation of tingling, pain or numbness in fingers and toes
signs of lung disorders: difficulty breathing or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs
signs of gastrointestinal disorders: abdominal pain, nausea, vomiting of blood, black or bloody
stools, constipation, heartburn, stomach acid reflux, swollen abdomen
signs of liver disorders: yellow skin and eyes, nausea, loss of appetite, dark-coloured urine
signs of liver infection: recurrence (reactivation of hepatitis B infection)
signs of eye disorders: visual disturbances including blurred vision, double vision, or perceived flashes of light, decreased sharpness or loss of vision, blood in eye, increased sensitivity of the eyes to light, eye pain, redness, itching or irritation, dry eye, swelling or itching of the eyelids
signs of electrolyte imbalance: nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal results of blood tests (such as
high levels of potassium, uric acid and phosphorous and low levels of calcium) Contact your doctor immediately if you notice any of the above side effects.
diarrhoea
headache
lack of energy
muscle pain
itching, rash
nausea
constipation
vomiting
hair loss
pain in limbs, bone pain and spinal pain on discontinuing treatment with Tasigna
slowing of growth in children and adolescents
upper respiratory tract infection including sore throat and runny or stuffy nose, sneezing
low level of blood cells (red cells, platelets) or haemoglobin
high blood level of lipase (pancreas function)
high blood level of bilirubin (liver function)
high blood level of alanine aminotransferases (liver enzymes)
pneumonia
abdominal pain, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen
bone pain, muscle spasms
pain (including neck pain)
dry skin, acne, decreased skin sensitivity
weight decrease or increase
insomnia, depression, anxiety
night sweats, excessive sweating
generally feeling unwell
nose bleed
signs of gout: painful and swollen joints
inability to achieve or maintain an erection
flu-like symptoms
sore throat
bronchitis
ear pain, hearing noises (e.g. ringing, humming) in the ears that have no external source (also called tinnitus)
haemorrhoids
heavy periods
itching at the hair follicles
oral or vaginal thrush
signs of conjunctivitis: discharge from the eye with itching, redness and swelling
eye irritation, red eyes
signs of hypertension: high blood pressure, headache, dizziness
flushing
signs of peripheral arterial occlusive disease: pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly
or not at all and noticeable changes in colour (blueness or paleness) or temperature (coolness) of the legs or arms (possible signs of a blocked artery in the affected leg, arm, toes or fingers)
shortness of breath (also called dyspnoea)
mouth sores with gum inflammation (also called stomatitis)
high blood level of amylase (pancreas function)
high blood level of creatinine (kidney function)
high blood level of alkaline phosphatase or creatine phosphokinase
high blood level of aspartate aminotransferases (liver enzymes)
high blood level of gamma glutamyltransferases (liver enzymes)
signs of leukopenia or neutropenia: low level of white blood cells
increase in the number of platelets or white cells in the blood
low blood level of magnesium, potassium, sodium, calcium or phosphorus
increased blood level of potassium, calcium or phosphorus
high blood level of fats (including cholesterol)
high blood level of uric acid
allergy (hypersensitivity to Tasigna)
dry mouth
breast pain
pain or discomfort on the side of the body
increased appetite
breast enlargement in men
herpes virus infection
muscle and joint stiffness, joint swelling
feeling body temperature change (including feeling hot, feeling cold)
disturbed sense of taste
frequent urine output
signs of inflammation of the stomach lining: abdominal pain, nausea, vomiting ,diarrhoea, bloating of the abdomen
memory loss
skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration
signs of psoriasis: thickened patches of red/silver skin
increased sensitivity of the skin to light
difficulty hearing
joint inflammation
urinary incontinence
inflammation of the intestine (also called enterocolitis)
anal abscess
nipple swelling
symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
signs of sepsis: fever, chest pain, elevated/increased heart rate, shortness of breath or rapid
breathing
skin infection (subcutaneous abscess)
skin wart
increase in specific types of white blood cells (called eosinophils)
signs of lymphopenia: low level of white blood cells
high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus levels)
high blood level of lactate dehydrogenase (an enzyme)
signs of low blood level of sugar: nausea, sweating, weakness, dizziness, trembling, headache
dehydration
abnormal blood level of fat
involuntary shaking (also called tremor)
difficulty concentrating
unpleasant and abnormal feeling when touched (also called dysaesthesia)
tiredness (also called fatigue)
sensation of numbness or tingling in the fingers and toes (also called peripheral neuropathy)
paralysis of any muscle of the face
red patch in the white of the eye caused by broken blood vessels (also called conjunctival haemorrhage
blood in eyes (also called eye haemorrhage)
eye irritation
signs of heart attack (also called myocardial infarction): sudden and crushing chest pain, tiredness, irregular heartbeat
signs of heart murmur: tiredness, chest discomfort, light-headedness, chest pain, palpitations
fungal infection of the feet
signs of heart failure: breathlessness, difficulty breathing when lying down, swelling of the feet or legs
pain behind the breast bone (also called pericarditis)
signs of hypertensive crisis: severe headache, dizziness, nausea
leg pain and weakness brought on by walking (also called intermittent claudication)
signs of narrowing of the arteries of the limbs: possible high blood pressure, painful cramping in one or both hips, thighs or calf muscles after certain activities such as walking or climbing
stairs, leg numbness or weakness
bruising (when you have not hurt yourself)
fatty deposits in the arteries that can cause blockage (also called arteriosclerosis)
signs of low blood pressure (also called hypotension): light-headedness, dizziness or fainting
signs of pulmonary oedema: breathlessness
signs of pleural effusion: fluid collection between the layers of tissue that line the lungs and chest cavity (which, if severe, can decrease the heart’s ability to pump blood), chest pain, cough,
hiccups, rapid breathing
signs of interstitial lung disease: cough, difficulty breathing, painful breathing
signs of pleuritic pain: chest pain
signs of pleurisy: cough, painful breathing
hoarse voice
signs of pulmonary hypertension: high blood pressure in the arteries of the lungs
wheezing
sensitive teeth
signs of inflammation (also called gingivitis): gum bleeding, tender or enlarged gums
high blood level of urea (kidney function)
change in blood proteins (low level of globulins or presence of paraprotein)
high blood level of unconjugated bilirubin
high blood level of troponins
reddening and/or swelling and possibly peeling on the palms of the hands and soles of the feet (so-called hand-foot syndrome)
warts in the mouth
feeling of hardening or stiffness in the breasts
inflammation of the thyroid gland (also called thyroiditis)
disturbed or depressed mood
signs of secondary hyperparathyroidism: bone and joint pain, excessive urination, abdominal pain, weakness, tiredness
signs of narrowing of the arteries in the brain: loss of vision in part or all of both eyes, double
vision, vertigo (spinning sensation), numbness or tingling, loss of coordination, dizziness or confusion
swelling of the brain (possible headache and/or mental status changes)
signs of optic neuritis: blurred vision, loss of vision
signs of heart dysfunction (ejection fraction decreased): tiredness, chest discomfort, light- headedness, pain, palpitations
low or high blood level of insulin (a hormone regulating blood sugar level)
low blood level of insulin C peptide (pancreas function)
sudden death
signs of heart dysfunction (ventricular dysfunction): shortness of breath, exertion at rest,
irregular heartbeat, chest discomfort, light-headedness, pain, palpitations, excessive urination, swelling in the feet, ankles and abdomen.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the
environment.
The active substance is nilotinib.
Each 50 mg hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate
Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide
(E172)
Printing ink: Shellac (E904), black iron oxide (E172), propylene glycol, ammonium hydroxide
Each 150 mg hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate
Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide
(E172)
Printing ink: Shellac (E904), black iron oxide (E172), n-butyl alcohol, propylene glycol, dehydrated ethanol, isopropyl alcohol, ammonium hydroxide
Each 200 mg hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
The other ingredients are:
Capsule content: Lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate
Capsule shell: Gelatin, titanium dioxide (E171), yellow iron oxide (E172)
Printing ink: Shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, red iron oxide (E172)
Tasigna 50 mg is supplied as hard capsules. The hard capsules are red/light yellow. A black imprint is stamped on each hard capsule (“NVR/ABL”).
Tasigna 150 mg is supplied as hard capsules. The hard capsules are red. A black imprint is stamped on
each hard capsule (“NVR/BCR”).
Tasigna 200 mg is supplied as hard capsules. The hard capsules are light yellow. A red imprint is stamped on each hard capsule (“NVR/TKI”).
Tasigna 50 mg hard capsules are available in a pack containing 120 hard capsules (3 packs of 40 hard capsules).
Tasigna 150 mg hard capsules are available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard
capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Tasigna 200 mg hard capsules are available in a wallet containing 28 hard capsules and in a carton
containing 28 or 40 hard capsules. Tasigna is also available in multipacks of 112 hard capsules (comprising 4 wallets, each containing 28 hard capsules), 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Not all packs may be marketed in your country.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg Germany
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D Lendava, 9220
Slovenia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 555
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
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Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370
. There are also links to other websites about rare diseases and treatments.