tafamidis: package leaflet

Vyndaqel contains the active substance tafamidis.

Vyndaqel is a medicine which treats a disease called transthyretin amyloidosis Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) that does not work properly. TTR is a protein that carries other substances, such as hormones, through the body.

In patients with this disease, TTR breaks up and may form fibres called amyloid. Amyloid can build up around your nerves (known as transthyretin amyloid polyneuropathy or ATTR-PN) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs, it prevents them from working normally.

Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further progression.

Do not take Vyndaqel

If you are allergic to tafamidis meglumine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vyndaqel.


Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel. There are no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have the symptoms of transthyretin amyloidosis. Vyndaqel is therefore not used for children and adolescents.

Other medicines and Vyndaqel

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

You should inform your doctor or pharmacist if you are taking any of the following:

• non-steroidal anti-inflammatory drugs
• diuretic medicines (e.g. furosemide, bumetanide)
• anti-cancer medicines (e.g. methotrexate, imatinib)
• statins (e.g. rosuvastatin, atorvastatin)
• anti-clotting medicines (e.g. apixaban, rivaroxaban)
• anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)

Pregnancy, breast-feeding and fertility

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.


You should not take Vyndaqel if you are pregnant or breast-feeding.

If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.

Driving and using machines

Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.

Vyndaqel contains sorbitol

This medicine contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one Vyndaqel 20 mg (tafamidis meglumine) capsule taken once a day.

If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.

Method of administration

Vyndaqel is for oral use.
The soft capsule should be swallowed whole, not crushed or cut.
The capsule may be taken with or without food.

Instructions for opening the blisters


Tear off one individual blister from the blister card along the perforated line.

Push capsule through the aluminium foil.

If you take more Vyndaqel than you should

You should not take more capsules than your doctor tells you to. If you take more capsules than you have been told to take, contact your doctor.

If you forget to take Vyndaqel

If you forget to take a dose, take your capsules as soon as you remember. If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vyndaqel

Do not stop taking Vyndaqel without first speaking to your doctor. As Vyndaqel works by stabilising the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilised, and your disease may progress.

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.

Very common: may affect more than 1 in 10 people are listed below:

Diarrhoea

Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)  Stomach ache or abdominal pain

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.

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 card and on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

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.

What Vyndaqel contains


The active substance is tafamidis. Each capsule contains 20 mg micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.


The other ingredients are: gelatine (E 441), glycerine (E 422), sorbitol (E 420) [see section 2 “Vyndaqel contains sorbitol”], mannitol (E 421), sorbitan, yellow iron oxide (E 172), titanium dioxide (E 171), purified water, macrogol 400 (E 1521), sorbitan monooleate (E 494), polysorbate 80 (E 433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), carmine (E 120), brilliant blue FCF (E 133) and ammonium hydroxide (E 527).

What Vyndaqel looks like and contents of the pack

Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) printed with “VYN 20” in red. Vyndaqel is available in two pack sizes of PVC/PA/alu/PVC-alu perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Service Company BV
Hermeslaan 11
1932 Zaventem
Belgium

Or

Millmount Healthcare Limited
Block 7, City North Business Campus
Stamullen
K32 YD60
Ireland

Or

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

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

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333
Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Malta
Vivian Corporation Ltd.
Tel: +356 21344610
Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00
Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636
Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000
Norge
Pfizer AS
Tlf: +47 67 52 61 00
Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800
Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500
France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00
Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400
Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500
Ísland
Icepharma hf.
Sími: +354 540 8000
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.

This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.

The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder’s local office number that is provided in this leaflet.

Vyndaqel contains the active substance tafamidis.

Vyndaqel is a medicine which treats a disease called transthyretin amyloidosis. Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) that does not work properly. TTR is a protein that carries other substances, such as hormones, through the body.

In patients with this disease, TTR breaks up and may form fibres called amyloid. Amyloid can build up between cells in your heart (known as transthyretin amyloid cardiomyopathy or ATTR-CM) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs in your heart, it prevents your heart from working normally.

Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients whose heart has been affected (people with symptomatic cardiomyopathy).

Do not take Vyndaqel

If you are allergic to tafamidis or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vyndaqel.


Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel. There are no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have the symptoms of transthyretin amyloidosis. Vyndaqel is therefore not used for children and adolescents.

Other medicines and Vyndaqel

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

You should inform your doctor or pharmacist if you are taking any of the following:

• non-steroidal anti-inflammatory drugs
• diuretic medicines (e.g. furosemide, bumetanide)
• anti-cancer medicines (e.g. methotrexate, imatinib)
• statins (e.g. rosuvastatin, atorvastatin)
• anti-clotting medicines (e.g. apixaban, rivaroxaban)
• anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)

Pregnancy, breast-feeding and fertility

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.


You should not take Vyndaqel if you are pregnant or breast-feeding.

If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.

Driving and using machines

Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.

Vyndaqel contains sorbitol

This medicine contains no more than 44 mg sorbitol in each capsule. Sorbitol is a source of fructose.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one Vyndaqel 61 mg (tafamidis) capsule taken once a day.

If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.

Method of administration

Vyndaqel is for oral use.
The soft capsule should be swallowed whole, not crushed or cut.
The capsule may be taken with or without food.

Instructions for opening the blisters


Tear off one individual blister from the blister card along the perforated line.

Push capsule through the aluminium foil.

If you take more Vyndaqel than you should

You should not take more capsules than your doctor tells you to. If you take more capsules than you have been told to take, contact your doctor.

If you forget to take Vyndaqel

If you forget to take a dose, take your capsules as soon as you remember. If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vyndaqel

Do not stop taking Vyndaqel without first speaking to your doctor. As Vyndaqel works by stabilising the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilised, and your disease may progress.

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.

Common: may affect up to 1 in 10 people

Diarrhoea

Rash, itching

In clinical studies, the side effects in patients taking Vyndaqel were generally similar to that of patients not taking Vyndaqel. Flatulence and increase in liver function tests were reported more often in ATTR-CM patients treated with Vyndaqel.

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.

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 card and on the carton. The expiry date refers to the last day of that month.

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.

What Vyndaqel contains


The active substance is tafamidis. Each capsule contains 61 mg micronized tafamidis.


The other ingredients are: gelatine (E 441), glycerine (E 422), sorbitol (E 420) [see section 2 “Vyndaqel contains sorbitol”], mannitol (E 421), sorbitan, red iron oxide (E 172), purified water, macrogol 400 (E 1521), polysorbate 20 (E 432), povidone (K-value 90), butylated hydroxytoluene (E321), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E 1520), titanium dioxide (E 171), and ammonium hydroxide (E 527).

What Vyndaqel looks like and contents of the pack

Vyndaqel soft capsules are reddish brown, opaque, oblong (approximately 21 mm) printed with “VYN 61” in white. Vyndaqel is available in two pack sizes of PVC/PA/alu/PVC-alu perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Service Company BV
Hermeslaan 11
1932 Zaventem
Belgium

Or

Millmount Healthcare Limited
Block 7, City North Business Campus
Stamullen
K32 YD60
Ireland

Or

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

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

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333
Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Malta
Vivian Corporation Ltd.
Tel: +356 21344610
Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00
Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636
Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000
Norge
Pfizer AS
Tlf: +47 67 52 61 00
Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800
Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500
France
Pfizer
Tél +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00
Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400
Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500
Ísland
Icepharma hf.
Sími: +354 540 8000
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

This leaflet was last revised in <{MM/YYYY}>.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder’s local office number that is provided in this leaflet.

Vyndaqel contains the active substance tafamidis.

Vyndaqel is a medicine which treats a disease called transthyretin amyloidosis. Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) that does not work properly. TTR is a protein that carries other substances, such as hormones, through the body.

In patients with this disease, TTR breaks up and may form fibres called amyloid. Amyloid can build up between cells in your heart (known as transthyretin amyloid cardiomyopathy or ATTR-CM) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs in your heart, it prevents your heart from working normally.

Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients whose heart has been affected (people with symptomatic cardiomyopathy).

Do not take Vyndaqel

If you are allergic to tafamidis or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Vyndaqel.


Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel. There are no data on the use of Vyndaqel in pregnant women.

Children and adolescents

Children and adolescents do not have the symptoms of transthyretin amyloidosis. Vyndaqel is therefore not used for children and adolescents.

Other medicines and Vyndaqel

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

You should inform your doctor or pharmacist if you are taking any of the following:

• non-steroidal anti-inflammatory drugs
• diuretic medicines (e.g. furosemide, bumetanide)
• anti-cancer medicines (e.g. methotrexate, imatinib)
• statins (e.g. rosuvastatin, atorvastatin)
• anti-clotting medicines (e.g. apixaban, rivaroxaban)
• anti-viral medicines (e.g. oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, lamivudine, zidovudine, zalcitabine)

Pregnancy, breast-feeding and fertility

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.


You should not take Vyndaqel if you are pregnant or breast-feeding.

If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.

Driving and using machines

Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.

Vyndaqel contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one Vyndaqel 61 mg (tafamidis) tablet taken once a day.

If you vomit after taking this medicine and can identify the intact Vyndaqel tablet, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel tablet, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.

Method of administration

Vyndaqel is for oral use.

The tablet should be swallowed whole, not crushed or cut.
The tablet may be taken with or without food.

Instructions for opening the blisters

Push tablet through the aluminium foil.

If you take more Vyndaqel than you should

You should not take more tablets than your doctor tells you to. If you take more tablets than you have been told to take, contact your doctor.

If you forget to take Vyndaqel

If you forget to take a dose, take your tablets as soon as you remember. If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vyndaqel

Do not stop taking Vyndaqel without first speaking to your doctor. As Vyndaqel works by stabilising the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilised, and your disease may progress.

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.

Common: may affect up to 1 in 10 people

Diarrhoea

Rash, itching

In clinical studies, the side effects in patients taking Vyndaqel were generally similar to that of patients not taking Vyndaqel. Flatulence and increase in liver function tests were reported more often in ATTR-CM patients treated with Vyndaqel.

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.

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 card and on the carton. The expiry date refers to the last day of that month.

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.

What Vyndaqel contains


The active substance is tafamidis. Each tablet contains 61 mg micronized tafamidis.


The other ingredients are: microcrystalline cellulose (E 460), lactose monohydrate (E 24) [see section 2 “Vyndaqel contains lactose monohydrate”], crospovidone (E 1202), magnesium stearate (E 470b), calcium carbonate, isomalt, hypromellose, and medium-chain triglycerides.

What Vyndaqel looks like and contents of the pack

Vyndaqel film-coated tablets are 11 mm round white to off-white and embossed with “61” on one side.
Vyndaqel is available in two pack sizes of OPA/Al/PVC-alu blisters.

Pack sizes: a pack of 3 x 10 film-coated tablets and a pack of 9 x 10 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

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

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333
Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000
Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111
Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00
Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00
Malta
Vivian Corporation Ltd.
Tel: +356 21344610
Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000
Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636
Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500
Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.,
Tel.: +48 22 335 61 00
France
Pfizer
Tél +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500
Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00
Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400
Ísland
Icepharma hf.
Sími: +354 540 8000
Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500
Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21
Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

This leaflet was last revised in <{MM/YYYY}>.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder’s local office number that is provided in this leaflet.