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Uptravi (selexipag) – Package leaflet - B01AC27

Updated on site: 10-Oct-2017

Medication nameUptravi
ATC CodeB01AC27
Substanceselexipag
ManufacturerActelion Registration Ltd

Package leaflet: Information for the patient

Uptravi 200 microgram film-coated tablets

Uptravi 400 microgram film-coated tablets

Uptravi 600 microgram film-coated tablets

Uptravi 800 microgram film-coated tablets

Uptravi 1,000 microgram film-coated tablets

Uptravi 1,200 microgram film-coated tablets

Uptravi 1,400 microgram film-coated tablets

Uptravi 1,600 microgram film-coated tablets

Selexipag

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before 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 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 have any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet

1.What Uptravi is and what it is used for

2.What you need to know before you take Uptravi

3.How to take Uptravi

4.Possible side effects

5.How to store Uptravi

6.Contents of the package and other information

1.What Uptravi is and what it is used for

Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen.

Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be used on its own if the patient is not a candidate for these medicines.

PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other symptoms.

By mimicking the action of prostacyclin, Uptravi widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. It relieves

the symptoms of PAH and improves the course of the disease.

2. What you need to know before you take Uptravi

Do not take Uptravi

-if you are allergic to selexipag or any of the other ingredients of this medicine (listed in section 6).

-if you have a heart problem, such as:

-poor blood flow to the heart muscles (severe coronary heart disease or unstable angina); symptoms can include chest pain

-heart attack within the last 6 months

-weak heart (decompensated cardiac failure) that is not under close medical observation

-severe irregular heartbeat

-defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension)

-if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g., transient ischaemic attack)

-if you are taking gemfibrozil (medicine used to lower the level of fats [lipids] in the blood)

Warnings and precautions

Talk to your PAH doctor or nurse before taking Uptravi if you

-are taking medicines for high blood pressure

-have low blood pressure associated with symptoms such as dizziness

-have recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting

-have problems with your thyroid gland

-have severe problems with your kidneys or are undergoing dialysis

-have or have had severe problems with your liver not working properly

-are taking clopidogrel, deferasirox, or teriflunomide

If you notice any of the above signs or your condition changes, tell your doctor immediately.

Children and adolescents

Do not give this medicine to children under 18 years of age, because Uptravi has not been tested in children.

Elderly patients

There is limited experience with Uptravi in patients older than 75 years. Uptravi should be used with caution in this age group.

Other medicines and Uptravi

Tell your doctor if you are taking, have recently taken, or might take any other medicines. Taking other medicines may affect how Uptravi works.

Talk to your PAH doctor or nurse if you are taking any of the following medicines:

-Gemfibrozil (medicine used to lower the level of fats [lipids] in the blood)

-Clopidogrel (medicine used to inhibit blood clots in coronary artery disease)

-Deferasirox (medicine used to remove iron from the blood stream)

-Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis)

-Carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work)

-Phenytoin (medicine used to treat epilepsy)

-Valproic acid (medicine used to treat epilepsy)

-Probenecid (medicine used to treat gout)

-Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections)

Pregnancy and breast-feeding

Uptravi is not recommended during pregnancy and breast-feeding. If you are a woman who can have children, you should use an effective contraceptive method while taking Uptravi. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Uptravi can cause side effects such as headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.

3.How to take Uptravi

Uptravi should only be prescribed by a doctor experienced in the treatment of PAH. Always take Uptravi exactly as your doctor has told you. Check with your doctor if you are not sure or have any questions.

If you have poor vision or experience any type of blindness, get help from another person when taking Uptravi during the titration period.

Finding the right dose for you

At the start of treatment, you will take the lowest dose. This is one 200 microgram tablet in the morning and another 200 microgram tablet in the evening. Treatment should be initiated in the evening. Your doctor will instruct you to gradually increase your dose. This is called titration. It lets your body adjust to the new medicine. The goal of titration is to reach the most appropriate dose. This

will be the highest dose you can tolerate, which may reach the maximum dose of 1,600 micrograms in the morning and in the evening.

The first pack of tablets you receive will contain the light-yellow 200 microgram tablets.

Your doctor will tell you to increase your dose in steps, usually every week but the interval between increases could be longer.

With each step, you will add one 200 microgram tablet to your morning dose and another

200 microgram tablet to your evening dose. The first intake of the increased dose should be in the evening. The diagram below shows the number of tablets to take every morning and every evening for the first 4 steps.

If your doctor instructs you to further increase your dose and move to step 5, this may be done by taking one green 800 microgram tablet and one light-yellow 200 microgram tablet in the morning and one 800 microgram tablet and one 200 microgram tablet in the evening.

If your doctor tells you to increase your dose further, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose with each new step. The first intake of the increased dose should be in the evening. The maximum dose of Uptravi is 1,600 micrograms in

the morning and 1,600 micrograms in the evening. However, not every patient will reach this dose, because different patients require different doses.

The diagram below shows the number of tablets to take every morning and every evening at each step, starting with step 5.

The titration pack also contains a titration guide providing information on the titration process and allowing you to record the number of tablets you take every day.

Remember to record the number of tablets you take every day in your titration diary. The titration steps usually last about 1 week. If your doctor instructs you to prolong each titration step longer than 1 week, there are additional diary pages to allow you to track this. Remember to talk to your PAH doctor or nurse regularly during titration.

Stepping down to a lower dose due to side effects

During titration, you may experience side effects such as headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face (see

section 4). If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them. There are treatments available that can help relieve the side effects. For example, painkillers such as paracetamol may help treat pain and headache.

If the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram light-yellow tablets you take

by one in the morning and by one in the evening. The diagram below shows stepping down to a lower dose. Do this only if instructed to do so by your doctor.

If your side effects are manageable after stepping down your dose, your doctor may decide that you should stay on that dose. Please see section Maintenance dose below for more information.

Maintenance dose

The highest dose that you can tolerate during titration will become your maintenance dose. Your maintenance dose is the dose you should continue to take on a regular basis.

Your doctor will prescribe a suitable tablet strength for your maintenance dose. This allows you to take one tablet in the morning and one in the evening, instead of multiple tablets each time.

For a full description of Uptravi tablets, including colours and marking, please see section 6 of this leaflet.

Over time, your doctor may adjust your maintenance dose as needed.

If, at any time, after taking the same dose for a long time, you experience side effects that you cannot

tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced. The doctor may then prescribe you a lower single-tablet strength. Please

remember to dispose of unused tablets (see section 5).

Take Uptravi once in the morning and once in the evening, about 12 hours apart.

Take the tablets with meals as you might tolerate your medicine better. Swallow the tablets whole with a glass of water. Do not split, crush or chew the tablets.

If you take more Uptravi than you should

If you have taken more tablets than you have been told to take, ask your doctor for advice.

If you forget to take Uptravi

If you forget to take Uptravi, take a dose as soon as you remember, then continue to take your tablets at the usual times. If it is nearly time for your next dose (within 6 hours before you would normally

take it), you should skip the missed dose and continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Uptravi

Suddenly stopping your treatment with Uptravi might lead to your symptoms getting worse. Do not stop taking Uptravi unless your doctor tells you to. Your doctor may tell you to reduce the dose gradually before stopping completely.

If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 3 morning and 3 evening doses, or 6 doses in a row or more), contact your doctor immediately as your dose

may need to be adjusted to avoid side effects. Your doctor may decide to restart your treatment on a lower dose, gradually increasing to your previous maintenance dose.

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

4.Possible side effects

Like all medicines, Uptravi can cause side effects. You may experience side effects not only during the titration period when your dose is being increased, but also later after taking the same dose for a

long time.

If you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick

(vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face, that you cannot tolerate or that cannot be treated, you should contact your doctor as the dose you are taking

maybe too high for you and may need to be reduced.

Very common side effects (may affect more than 1 in 10 people)

-Headache

-Flushing (reddening of the face)

-Nausea and vomiting (feeling sick and being sick)

-Diarrhoea

-Jaw pain, muscle pain, joint pain, leg pain

-Nasopharyngitis (stuffy nose)

Common side effects (may affect up to 1 in 10 people)

-Anaemia (low red blood cell levels)

-Hyperthyroidism (overactive thyroid gland)

-Decreased appetite

-Weight loss

-Hypotension (low blood pressure)

-Stomach pain

-Pain

-Changes in some blood test results including those measuring blood cell counts or your thyroid function

-Rashes, including hives, may cause a burning or stinging sensation and skin redness

Uncommon side effects (may affect up to 1 in 100 people)

-Increased heart rate

Reporting of side effects

If you have any side effects, talk to your doctor. 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 Uptravi

Keep this medicine out of the sight and reach of children.

Do not use Uptravi after the expiry date, which is stated on the carton and on the blister after “EXP.” The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

No special requirements for disposal.

6. Contents of the pack and other information

What Uptravi contains

-The active substance is selexipag.

Uptravi 200 microgram film-coated tablets contain 200 micrograms of selexipag Uptravi 400 microgram film-coated tablets contain 400 micrograms of selexipag Uptravi 600 microgram film-coated tablets contain 600 micrograms of selexipag Uptravi 800 microgram film-coated tablets contain 800 micrograms of selexipag Uptravi 1,000 microgram film-coated tablets contain 1,000 micrograms of selexipag

Uptravi 1,200 microgram film-coated tablets contain 1,200 micrograms of selexipag Uptravi 1,400 microgram film-coated tablets contain 1,400 micrograms of selexipag Uptravi 1,600 microgram film-coated tablets contain 1,600 micrograms of selexipag

-The other ingredients are: In the tablet core:

Mannitol (E421), maize starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate

In the film coat:

Hypromellose, propylene glycol, titanium dioxide (E171), carnauba wax and iron oxides (see

below).

Uptravi 200 microgram film-coated tablets contain iron oxide yellow (E172). Uptravi 400 microgram film-coated tablets contain iron oxide red (E172).

Uptravi 600 microgram film-coated tablets contain iron oxide red and iron oxide black (E172). Uptravi 800 microgram film-coated tablets contain iron oxide yellow and iron oxide black

(E172).

Uptravi 1,000 microgram film-coated tablets contain iron oxide red and iron oxide yellow (E172).

Uptravi 1,200 microgram film-coated tablets contain iron oxide black and iron oxide red (E172).

Uptravi 1,400 microgram film-coated tablets contain iron oxide yellow (E172).

Uptravi 1,600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).

What Uptravi looks like and contents of the pack

Uptravi 200 microgram film-coated tablets: Round, light-yellow, film-coated tablets with “2” marked on one side.

Uptravi 400 microgram film-coated tablets: Round, red, film-coated tablets with “4” marked on one side.

Uptravi 600 microgram film-coated tablets: Round, light-violet, film-coated tablets with “6” marked on one side.

Uptravi 800 microgram film-coated tablets: Round, green, film-coated tablets with “8” marked on one side.

Uptravi 1,000 microgram film-coated tablets: Round, orange, film-coated tablets with “10” marked on one side.

Uptravi 1,200 microgram film-coated tablets: Round, dark-violet, film-coated tablets with “12” marked on one side.

Uptravi 1,400 microgram film-coated tablets: Round, dark-yellow, film-coated tablets with “14” marked on one side.

Uptravi 1,600 microgram film-coated tablets: Round, brown, film-coated tablets with “16” marked on one side.

Uptravi 200 microgram film-coated tablets are supplied in blister packs of 10 or 60 tablets and 60 or 140 tablets (titration packs).

Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets are supplied in blister packs of 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actelion Registration Ltd

Chiswick Tower 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

Tel: +44 20 8987 3320

Manufacturer

Actelion Manufacturing GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

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

België/Belgique/Belgien

Lietuva

Actelion Pharmaceuticals Belgium N.V.

UAB ALGOL PHARMA

Tél/Tel: +32-(0)15 284 777

Tel: +370 37 40 86 81

България

Luxembourg/Luxemburg

Аквахим AД

Actelion Pharmaceuticals Belgium N.V.

Teл.: +359 2 807 50 00

Tél/Tel: +32-(0)15 284 777

Česká republika

Magyarország

Actelion Pharmaceuticals CZ, s.r.o.

Actelion Pharmaceuticals Hungaria Kft.

Tel: +420 221 968 006

Tel: +36-1-413-3270

Danmark

Malta

 

Actelion Danmark,

Actelion Pharmaceuticals Ltd

Filial af Actelion Pharmaceuticals Sverige AB,

Tel: +44

208 987 3333

Sverige

 

 

Tlf: +45 3694 45 95

 

 

Deutschland

Nederland

Actelion Pharmaceuticals Deutschland GmbH

Actelion Pharmaceuticals Nederland B.V.

Tel: +49 761 45 64 0

Tel: +31

(0)348 435950

Eesti

Norge

 

Algol Pharma OÜ

Actelion Pharmaceuticals Sverige AB,

Tel: +372 605 6014

Filial Norge

 

Tlf: +47 22480370

Ελλάδα

Österreich

Actelion Pharmaceuticals Eλλάς Α.Ε.

Actelion Pharmaceuticals Austria GmbH

Τηλ: +30 210 675 25 00

Tel: +43 1 505 4527

España

Polska

 

Actelion Pharmaceuticals España S.L.

Actelion Pharma Polska Sp. z o.o.

Tel: +34 93 366 43 99

Tel: +48 (22) 262 31 00

France

Portugal

Actelion Pharmaceuticals France SAS

Actelion Pharmaceuticals Portugal Lda.

Tél: +33 1 58 62 32 32

Tel: +351 21 358 6120

Hrvatska

România

Medis Adria d.o.o.

Geneva Romfarm International SRL

Tel: + 385 (0) 1 2303 446

Tel: + 40 (021) 231 3561

Ireland

Slovenija

Actelion Pharmaceuticals UK Ltd

Medis d.o.o.

Tel: +44 208 987 3333

Tel: +386-(0)1 589 69 00

Ísland

Slovenská republika

Actelion Pharmaceuticals Sverige AB

Actelion Pharmaceuticals SK, s.r.o.

Sími: +46 (0)8 544 982 50

Tel: +420 221 968 006

Italia

Suomi/Finland

Actelion Pharmaceuticals Italia S.r.l.

Actelion Pharmaceuticals Sverige AB,

Tel: +39 0542 64 87 40

Filial Finland

 

Puh/Tel: +358 9 2510 7720

Κύπρος

Sverige

 

Actelion Pharmaceuticals Eλλάς Α.Ε.

Actelion Pharmaceuticals Sverige AB

Τηλ: +30 210 675 25 00

Tel: +46 8 544 982 50

Latvija

United Kingdom

Algol Pharma SIA

Actelion Pharmaceuticals UK Ltd

Tel: +371 6761 9365

Tel: +44 208 987 3333

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

TITRATION GUIDE - TITRATION PACK

Page 1

Uptravifilm-coated tablets selexipag

Titration Guide

Starting TreatmentWithUptravi

Please read the accompanyingpatientinformation leaflet before startingtreatment.

Page 2

 

Page 3

 

Contents

 

 

 

How should you take Uptravi? ...................................

When you move to your maintenance dose

.............14

How should you stepup your dose?...........................

If you forget to take Uptravi.....................................

What are the steps? .....................................................

If you stoptaking Uptravi.........................................

When shouldyoustep down? ...................................

Titration diary...........................................................

Stepping down……………………………………..12

 

 

 

 

 

 

Page 4

 

Page 5

 

How should you take Uptravi?

Uptraviis a medicine taken every morning and evening for the treatmentof pulmonary arterial hypertension, alsocalled PAH.

The startingdosefor Uptraviis 200 micrograms once in the morning and once in the evening.

The first intake of Uptravishould be in the evening. You should take eachdose with a glass of water, preferably duringa meal.

There are 2 phases of treatment with Uptravi:

Titration

In the first severalweeks, youwill workwith your doctor to find the dose of Uptravithatis right for you. Your doctor may haveyoustepup fromthe starting dose to higher doses of Uptravi. Your doctor may step you down to a lower dose. This process is called titration. It lets your bodygradually adjust tothe medicine.

Maintenance

Once your doctor has found the dose that is right for you, this will be the dose youtake on a regular basis. This is called the maintenancedose.

 

Page 6

Page 7

 

How should you step up your dose?

Every patient with PAH is different. Not everyone

 

 

will end up on the same maintenance dose.

 

You will start at the 200 microgram dose in the

Some patients may have 200 micrograms in the

 

morning and in the evening and after discussingwith

morning and in the evening as their maintenancedose,

 

your doctor or nurse stepup to the next dose.

while some will reach the highest dose of

 

The first intake of the increased dose should be in the

1,600 micrograms in the morning and in the evening.

 

evening. Each stepusually lasts about 1week. It could

Others may reach a maintenancedosesomewhere

 

take severalweeks to find thedosethatis right for

inbetween. What is important is thatyoureachthe

 

you.

dose that is most appropriate to treat you.

 

The goal is to reach the dose that is most

 

 

appropriate to treat you.

 

 

This dosewill be your maintenancedose.

 

 

Page 8

Page 9

 

 

 

Page 10

Page 11

When should you step down?

If you cannot toleratethe side effects evenafter your

 

doctor or nurse has tried totreat them, he or she may

As with all medicines, you may experience side effects

recommend you stepdownto a lower dose.

with Uptravias you stepup to higher doses.

 

Talk to your doctor or nurse if you have side

If your doctor or nurse tells you to stepdown to a

effects. There are treatments available that can

lower dose, you should take one less 200 microgram

help relieve them.

tablet in the morning and one less in the evening.

The most common side effects (may affect more than

You should onlystep down after speakingwith your

1 in 10 people) youmay experience while taking

PAH doctor or nurse. This stepping-down process will

Uptraviare:

help you find the dosethat is right for you, alsocalled

• Headache •Diarrhoea •Nausea •Vomiting • Jaw

your maintenancedose.

pain • Muscle pain •Leg pain • Joint pain • Facial

 

redness

 

For a full list of side effects seepackageleaflet for

 

further information.

 

 

 

Page 12

Page 13

 

 

Page 14

Page 15

When you move to your maintenance dose

For example, if your highesttolerateddose during

 

titration was 1,200 micrograms once in the morning

The highest dose that you cantolerate duringtitration

and once in the evening:

will become your maintenance dose. Your

 

maintenancedoseis the doseyoushould continue to

 

take on a regular basis. Your doctor or nurse can

 

prescribe an equivalent single-tablet strength for

 

your maintenancedose.

Over time, your doctor or nurse may adjust your

This lets you take just one tablet in the morning

and one in the evening, insteadof multiple tablets

maintenance dose as needed.

for each dose.

 

 

 

Page 16

Page 17

If you forget to take Uptravi

If you stop taking Uptravi

If you miss a dose, take the dose as soon as you

Do not stoptaking Uptraviunless your doctor or nurse

remember, then continue to take your tablets at the

tells you to. If, for any reason, youstoptakingUptravi

usualtimes. If it is within 6 hours of when you would

for more than 3consecutive days (if you missed

normally take your next dose, youshouldskip the

6 doses in a row), contact your PAH doctor or nurse

missed dose andcontinueto take your medicine at the

immediately as your dose may need to be adjusted

usualtime.

to avoid side effects.

Do not take a double dose to make up for a

 

forgotten tablet.

Your doctor or nurse may have you resume treatment

 

at a lower dose, gradually increasingto your previous

 

maintenancedose.

 

Page 18

Page 19

 

Titration diary

Remember to talk to your PAH doctor or nurse

 

Please readthe instructions in the package leaflet

regularly.

 

 

 

carefully.

Write down your doctor or nurse’s instructions:

 

The following diary pages help youkeep trackof the

 

 

number of tablets youneedto take in the morning and

 

 

evening duringtitration.

 

 

Use themto write down the number of tablets youtake

Doctor’s office telephone ande-mail:

 

in the morning and theevening.

 

 

Each step usually lasts about 1week, unless your

Pharmacist’s telephone:

 

doctor or nurse instructs youotherwise. If your

 

 

titration steps lastlonger than1weekthere are

 

 

additionaldiary pages totrackthis.

Notes:

 

Use pages 20to 27 to trackthe first weeks of

 

 

treatment, when you are using200microgram

 

 

tablets only (steps 1–4).

 

 

If you havebeenprescribedboth 200and

 

 

800 microgram tablets, use pages 30to 37

 

 

(steps 5–8).

 

 

Page 20

Page 21

 

 

 

Page 22

Page 23

 

 

Page 24

Page 25

 

 

Page 26

Page 27

 

 

Page 28

Page 29

Use the following diary pages if your doctor or nurse

Remember to talk to your PAH doctor or nurse

prescribes 800microgram tablets in additionto your

regularly.

200 microgram tablets.

Write down your doctor or nurse’s instructions:

On the diary pages, checkoff that youhave takenone

 

800 microgram tablet every day in the morning and in

Doctor’s office telephone ande-mail:

the eveningwith your prescribed number of

200 microgram tablets.

 

 

Pharmacist’s telephone:

 

Notes:

 

 

Page 30

Page 31

 

 

Page 32

Page 33

 

 

Page 34

Page 35

 

 

Page 36

Page 37

 

 

Page 38

Page 39

Notes

 

 

 

Page 40

Actelion Pharmaceuticals Ltd.

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