Yeytuo
Italy
Table of Contents
Package leaflet: Information for the patient
Yeytuo 464 mg injection solution
lenacapavir
Please read 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 questions, ask your doctor, pharmacist or nurse.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- What Yeytuo is and what it is used for
- What you need to know before you are given Yeytuo
- How Yeytuo is administered
- Possible side effects
- How to store Yeytuo
- Contents of the pack and other information
1. What Yeytuo is and what it is used for
Yeytuo contains the active substance lenacapavir. It is a long-acting antiretroviral medicine known as a capsid inhibitor. Lenacapavir, the active ingredient in Yeytuo, binds to the outer shell proteins of the HIV-1 virus, blocking its ability to replicate and spread.
Yeytuo is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV-1. This is known as pre-exposure prophylaxis (PrEP). It must be used in combination with safe sexual practices.
2. What you should know before being given Yeytuo
Do not receive Yeytuo
- If you are allergic to lenacapavir or to any of the other ingredients of this medicine (listed in section 6).
- If you do not know whether you have HIV. You must be tested to make sure you do not already have HIV before starting treatment with Yeytuo. Yeytuo can only prevent HIV if you have not already contracted it.
- If you are taking any of the following medicines:
- rifampicin, used to treat certain bacterial infections, such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures
- St John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety.
If you think any of these conditions apply to you, do not receive Yeytuo and inform your doctor or nurse immediately.
Warnings and precautions
- Taking Yeytuo alone may not prevent you from acquiring HIV. You must take additional measures to help prevent HIV while receiving Yeytuo.
- Always practice safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
- Do not share or reuse needles or other injection or drug administration equipment.
- Get tested for other sexually transmitted infections, such as syphilis and gonorrhoea. These infections increase the risk of acquiring HIV.
- Get tested for HIV when advised by your doctor or nurse. You must be tested regularly before starting Yeytuo treatment and before each injection to ensure you remain HIV-negative during therapy with this medicine.
- Keep all scheduled appointments to receive Yeytuo injections on time. If you are considering stopping the injections, discuss this with your doctor or nurse: stopping may increase your risk of acquiring HIV. If you stop treatment or miss a scheduled injection, you may need to take other medicines or take additional precautions to reduce the risk of acquiring HIV and possibly developing viral resistance.
- Inform your doctor or nurse immediately if you think you may have acquired HIV. They may want to perform further tests to confirm that you do not have HIV.
- If you develop flu-like illness, it could mean you have recently acquired HIV. These could be signs of HIV infection:
- fatigue
- fever
- joint or muscle pain
- headache
- vomiting or diarrhoea
- rash
- night sweats
- swollen lymph nodes in the neck or groin
Inform your doctor or nurse if you develop flu-like illness during the month before starting
treatment with Yeytuo or at any time while taking Yeytuo.
Contact your doctor or nurse if you have any further questions about how to prevent HIV infection.
- Yeytuo injectable is a long-acting medicine. If you stop receiving Yeytuo injections, lenacapavir (the active substance in Yeytuo) may remain in your body for a year or more after the last injection, but the amount present in your body may be too low to protect you from HIV.
- Reactions at the injection site
A hardened mass or nodule may form at the injection site. In some cases, these nodules may persist for more than a year and in some cases may never disappear. If the problem has not resolved by the time of your next injection, inform your doctor. For more information, see section 4, Possible side effects.
Children and adolescents
Do not administer this medicine to individuals weighing less than 35 kg, as it has not been studied in this population.
Other medicines and Yeytuo
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Yeytuo can interact with other medicines. This may prevent Yeytuo or the other medicines from working properly, or may worsen their side effects. In some cases, your doctor or nurse may need to adjust the dose or monitor blood levels.
Medicines that must never be taken with Yeytuo:
- rifampicin, used to treat certain bacterial infections, such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures
- St John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety.
If you are taking any of these medicines, do not receive Yeytuo injectable and inform your doctor or nurse immediately. Talk to your doctor or nurse especially if you are taking:
- Medicines used to treat certain bacterial infections, such as tuberculosis, containing:
- rifabutin or rifapentine
- Anticonvulsants used to treat epilepsy and prevent seizures, containing:
- oxcarbazepine or phenobarbital
- Medicines used to treat migraine, containing:
- dihydroergotamine or ergotamine
- Medicines used to treat erectile dysfunction and pulmonary hypertension, containing:
- sildenafil or tadalafil
- Medicines used to treat erectile dysfunction, containing:
- vardenafil
- Corticosteroids (also known as “steroids”) taken orally or administered by injection, used to treat allergies, inflammatory bowel diseases, and other conditions causing inflammation, containing:
- dexamethasone or hydrocortisone/cortisone
- Medicines used to lower cholesterol, containing:
- lovastatin or simvastatin
- Antiarrhythmics used to treat heart problems, containing:
- digoxin
- Medicines used to aid sleep, containing:
- midazolam or triazolam
- Anticoagulants used to prevent and treat blood clots, containing:
- rivaroxaban, dabigatran or edoxaban.
Inform your doctor or nurse if you are taking any of these medicines or if you start taking them during treatment with Yeytuo. Do not stop treatment without contacting your doctor or nurse.
Yeytuo is a long-acting medicine. If, after speaking with your doctor or nurse, you decide to stop treatment with this medicine, you should know that low levels of lenacapavir may remain in your body for many months after the last injection. Other medicines could be affected by low levels of lenacapavir in your body if taken within 9 months after the last Yeytuo injection. You should ask your doctor or nurse whether these medicines can be taken safely after stopping Yeytuo treatment.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor or nurse.
Driving and using machines
Yeytuo should not affect your ability to drive or operate machinery.
Yeytuo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per injection, i.e., essentially ‘sodium-free’.
3. How Yeytuo is administered
Before starting treatment with Yeytuo and before each injection, you must have a negative HIV test.
At the beginning of Yeytuo therapy, you will take oral tablets and the doctor or nurse will administer injections under your skin (subcutaneously). Afterwards, the injections will be given every 6 months.
Day 1:
- Two tablets to be taken by mouth. These may be taken with or without food.
- Two injections administered by the doctor or nurse. The two injections will be given simultaneously, at least 5 centimeters apart, and may be administered in the abdomen (stomach) or thigh.
Day 2:
- Two tablets to be taken by mouth, as above.
Every 6 months:
- Two injections administered by the doctor or nurse, as above.
If you have difficulty swallowing the whole tablet, you may split it in half. To take the full dose, take both halves of the tablet one after the other. Do not store the split tablet.
It is important to keep your scheduled appointments every 6 months (26 weeks) to receive your Yeytuo injections. This will continue to help protect you from HIV infection.
- Schedule an appointment with your doctor or nurse to ensure you receive your next injections on time.
- Subsequent injections should be administered within 28 weeks of the last injection.
If you are given more Yeytuo than you should receive
This medicine will be administered by your doctor or nurse; therefore, it is unlikely that you will receive an excessive amount. If you have any doubts, speak to your doctor or nurse.
If you miss an appointment for a Yeytuo injection
- If you are unable to attend a scheduled injection appointment, contact your doctor or nurse as soon as possible to discuss your options. If you need to postpone a scheduled injection appointment, as an alternative you may temporarily take Yeytuo tablets.
- Use of Yeytuo tablets if an injection appointment needs to be postponed
- Take one tablet by mouth every 7 days until injections are resumed. The tablets may be taken with or without food.
- It is important to continue taking Yeytuo as recommended by your doctor or nurse.
If you forget to take the tablets or vomit after taking them, refer to the Yeytuo tablet package leaflet for instructions on what to do.
Do not stop Yeytuo injections without speaking to your doctor or nurse
Continue receiving Yeytuo injections for the duration prescribed by your doctor or nurse. Do not stop treatment unless instructed by your doctor or nurse. Skipping injections or doses of Yeytuo tablets increases the risk of acquiring HIV.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects
(may affect more than 1 in 10 people)
- Reactions at the injection site of Yeytuo Symptoms may include:
- a hardened mass or nodule, which may take longer to disappear than other injection site reactions or may not disappear at all
- pain and discomfort
- inflammatory reaction such as redness, itching, and swelling
- open wound on the skin
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Yeytuo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the
packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light.
6. Package contents and other information
What Yeytuo contains
The active substance is lenacapavir. Each single-use vial contains 463.5 mg of lenacapavir.
The other components are
Macrogol (E1521), water for injectable preparations.
Description of the appearance of Yeytuo and package contents
Yeytuo injectable solution (injection) is a clear, yellow to brown solution, free from visible particles. Yeytuo is supplied in two glass vials, each containing 1.5 mL of injectable solution. The vials are contained within an injection kit which also includes 2 transfer needles (used by the doctor or nurse to withdraw Yeytuo from the vial), 2 single-use syringes, and 2 injection needles.
Marketing Authorization Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888
България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50
Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel.: + 353 (0) 1 686 1888
Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf.: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888
Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98
Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849
Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830
España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel.: + 48 22 262 8702
France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790
Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00
Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888
Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210
Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849
Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849
Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu
The following information is intended exclusively for healthcare professionals
Instructions for use - Yeytuo 464 mg injectable solution
Each package contains
| 2 vials |  |
| 2 syringes |  |
| 2 18 G, 40 mm transfer needles | |
| 2 22 G, 13 mm injection needles |  |
All components are for single use.
Two 1.5 mL injections are required for a complete dose. The 18 G needle is for withdrawal only.
Check that:
- The vial contains a yellow to brown solution free of particulate matter
- The contents are undamaged
- The product has not expired
| 1.Prepare the vial | |
 | Remove the cap. |
| Clean the vial stopper with an alcohol wipe. | |
2.Attach the 18 G transfer needle to the syringe | |
| Pink connector | |
3.Fill the syringe | |
| |
4.Remove the 18 G transfer needle from the syringe | |
| Pink connector | |
| 5.Attach the 22 G injection needle to the syringe, expel air bubbles, and prepare to administer 1.5 mL | |
Grey connector | |
| 6.Select and clean an injection site | |
= injection site options (at least 5 cm away from the navel) | Injection site options (at least 5 cm away from the navel) |
| 7.Administer 1.5 mL of Yeytuo subcutaneously | |
90° preferred 45° acceptable Insert completely | |
| 8.Administer the second injection | |
Repeat steps for the 2nd injection, at least 5 cm away from the first injection site | |
Package leaflet: Information for the user
Yeytuo 300 mg film-coated tablets
lenacapavir
Please read 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 questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Yeytuo is and what it is used for
- What you need to know before taking Yeytuo
- How to take Yeytuo
- Possible side effects
- How to store Yeytuo
- Contents of the pack and other information
1. What Yeytuo is and what it is used for
Yeytuo contains the active substance lenacapavir. It is a long-acting antiretroviral medicine known as a capsid inhibitor. Lenacapavir, the active substance in Yeytuo, binds to proteins in the outer layer of the HIV-1 virus, blocking its ability to replicate and spread.
Yeytuo is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV-1. This is known as pre-exposure prophylaxis (PrEP). It must be used in combination with safe sexual practices.
Your doctor will instruct you to take Yeytuo tablets when you receive your first Yeytuo injections.
If you are being treated with Yeytuo injections but plan to miss your scheduled injections, you may alternatively take Yeytuo tablets until you can receive the injections again (see section 3).
2. What you need to know before taking Yeytuo
Do not take Yeytuo
- If you are allergic to lenacapavir or to any of the other ingredients of this medicine (listed in section 6).
- If you do not know whether you have HIV. You must get tested to make sure you do not already have HIV before starting treatment with Yeytuo. Yeytuo can prevent HIV only if you have not already contracted it.
- If you are taking any of the following medicines:
- rifampicin, used to treat certain bacterial infections, such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures
- St John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety.
If you think any of these conditions apply to you, do not take Yeytuo and inform your doctor or nurse immediately.
Warnings and precautions
- Taking Yeytuo alone may not prevent you from acquiring HIV. You must take additional measures to help prevent HIV during treatment with Yeytuo.
- Always practice safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
- Do not share or reuse needles or other injection or drug administration equipment.
- Get tested for other sexually transmitted infections, such as syphilis and gonorrhoea. These infections can make it easier to contract HIV.
- Get tested for HIV when advised by your doctor or nurse. You must be tested before starting treatment with Yeytuo and before each injection to ensure you remain HIV-negative during treatment with this medicine.
- Keep all scheduled appointments for Yeytuo injections as planned. If you are considering stopping the injections, discuss this with your doctor or nurse: stopping may increase your risk of acquiring HIV. If you stop treatment or miss a scheduled injection appointment, you may need to take other medicines or take additional precautions to reduce the risk of acquiring HIV and possibly developing viral resistance.
- Inform your doctor or nurse immediately if you think you may have contracted HIV. They may want to perform further tests to confirm that you do not have HIV.
- If you develop flu-like illness, it could mean you have recently contracted HIV. These could be signs of HIV infection:
- fatigue
- fever
- joint or muscle pain
- headache
- vomiting or diarrhoea
- rash
- night sweats
- swollen lymph nodes in the neck or groin.
Inform your doctor or nurse if you experience flu-like illness within the month
before starting treatment with Yeytuo or at any time while taking
Yeytuo.
Talk to your doctor or nurse if you have further questions about how to prevent HIV infection.
Children and adolescents
Do not administer this medicine to individuals weighing less than 35 kg, as it has not been studied in these individuals.
Other medicines and Yeytuo
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Yeytuo can interact with other medicines. This may prevent Yeytuo or the other medicines from working properly, or may worsen their side effects. In some cases, your doctor or nurse may need to adjust the dose or monitor blood levels.
Medicines that must never be taken with Yeytuo:
- rifampicin, used to treat certain bacterial infections, such as tuberculosis
- carbamazepine, phenytoin, used to prevent seizures
- St John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety.
If you are taking any of these medicines, do not take Yeytuo and inform your doctor or nurse immediately.
Talk to your doctor or nurse, in particular if you are taking:
- medicines used to treat certain bacterial infections, such as tuberculosis, containing:
- rifabutin or rifapentine
- anticonvulsants used to treat epilepsy and prevent seizures, containing:
- oxcarbazepine or phenobarbital
- medicines used to treat migraine, containing:
- dihydroergotamine or ergotamine
- medicines used to treat erectile dysfunction and pulmonary hypertension, containing:
- sildenafil or tadalafil
- medicines used to treat erectile dysfunction, containing:
- vardenafil
- corticosteroids (also known as “steroids”) taken orally or administered by injection, used to treat allergies, inflammatory bowel diseases, and other conditions causing inflammation, containing:
- dexamethasone or hydrocortisone/cortisone
- medicines used to lower cholesterol, containing:
- lovastatin or simvastatin
- antiarrhythmics used to treat heart problems, containing:
- digoxin
- medicines used to aid sleep, containing:
- midazolam or triazolam
- anticoagulants used to prevent and treat blood clots, containing:
- rivaroxaban, dabigatran or edoxaban.
Inform your doctor or nurse if you are taking any of these medicines or if you start taking them during treatment with Yeytuo. Do not stop treatment without contacting your doctor or nurse.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking this medicine.
If you are breastfeeding or considering breastfeeding, discuss this with your doctor or nurse.
Driving and using machines
Yeytuo is unlikely to affect your ability to drive or use machines.
Yeytuo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
3. How to take Yeytuo
Before starting treatment with Yeytuo and before each injection, you must have a negative HIV test.
At the beginning of Yeytuo therapy, you will take oral tablets and your doctor or nurse will administer injections under your skin (subcutaneously). After that, the injections will be given every 6 months.
Day 1:
- Two tablets taken by mouth. These may be taken with or without food.
- Two injections administered by your doctor or nurse. The two injections will be given simultaneously, at least 5 centimeters apart, and may be administered in the abdomen (stomach) or thigh.
Day 2:
- Two tablets taken by mouth, as above.
Every 6 months:
- Two injections administered by your doctor or nurse, as described above.
If you have difficulty swallowing the tablet whole, you may split it in half. To take the full dose, take both halves of the tablet one after the other. Do not store a split tablet.
It is important that you attend all scheduled appointments every 6 months (26 weeks) to receive your Yeytuo injections. This will continue to help protect you from HIV infection.
- Schedule an appointment with your doctor or nurse to ensure you receive your next injections on time.
- Subsequent injections should be administered within 28 weeks of the last injection.
If you take more Yeytuo than you should
Contact your doctor, nurse, or pharmacist immediately for advice. If you take more Yeytuo than recommended, you may have an increased risk of experiencing possible side effects of this medicine (see section 4, Possible side effects).
It is important that you do not miss any doses of Yeytuo tablets.
If you forget to take the tablets, inform your doctor, nurse, or pharmacist immediately.
If you vomit within 3 hours after taking the Yeytuo tablets, contact your doctor or nurse right away and take two more tablets. If you vomit more than 3 hours after taking Yeytuo, you do not need to take additional tablets until your next scheduled tablet dose or injection.
If you miss an appointment for your Yeytuo injection
- If you are unable to attend a scheduled injection appointment, contact your doctor or nurse as soon as possible to discuss your options. If you cannot attend a scheduled injection appointment, you may temporarily take Yeytuo tablets instead.
- Use of Yeytuo tablets if you need to miss an injection appointment
- Take one tablet by mouth every 7 days until injections are resumed. The tablets may be taken with or without food.
- It is important to continue taking Yeytuo as recommended by your doctor or nurse.
Do not stop taking Yeytuo without talking to your doctor or nurse.
Take Yeytuo for the duration prescribed by your doctor. Do not stop treatment unless instructed by your doctor. Missing injections or failing to take Yeytuo tablets increases your risk of acquiring HIV.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Yeytuo
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 on the label of the
vial after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Yeytuo contains
The active substance is lenacapavir. Each tablet contains lenacapavir sodium equivalent to 300 mg of
lenacapavir.
The other components are
Tablet core
Mannitol (E421), microcrystalline cellulose (E460), sodium croscarmellose (E468), copovidone,
magnesium stearate (E572), poloxamer (see section 2, Yeytuo contains sodium).
Film coating
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).
Description of the appearance of Yeytuo and package contents
Yeytuo film-coated tablets are beige, capsule-shaped, film-coated tablets with “GSI” printed on one side and “62L” on the other. Yeytuo is available in a bottle containing 4 tablets.
Each bottle contains a silica desiccant gel pack, which must be left in the bottle to help protect the tablets. The silica desiccant is contained in a separate sachet and must not be ingested.
Marketing Authorization Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888
България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50
Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel.: + 353 (0) 1 686 1888
Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf.: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888
Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98
Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849
Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830
España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel.: + 48 22 262 8702
France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790
Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00
Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888
Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210
Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849
Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849
Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu
ANNEX IV
CONCLUSIONS ON THE REQUEST FOR ANNUAL EXTENSION OF COMMERCIAL PROTECTION
SUBMITTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions submitted by the European Medicines Agency on:
- extension of commercial protection for one additional year
In consideration of the provisions laid down in Article 14(11) of Regulation 726/2004/EC, the Committee for Medicinal Products for Human Use (CHMP) has reviewed the data submitted by the marketing authorization holder and considers that the new therapeutic indication provides a clinically relevant benefit compared to current therapy(ies), as further described in the European Public Assessment Report (EPAR).