LENZETTO 1,53 MG Cutaneous spray, solution

Зміст інструкції

1. Lenzetto 1.53 mg/nebulization, transdermal spray, solution
   1. What is Lenzetto and what is it used for
   2. What you need to know before using Lenzetto
   3. How to use Lenzetto
   4. Possible side effects
   5. How to store Lenzetto
   6. Contents of the pack and other information

Lenzetto 1.53 mg/nebulization, transdermal spray, solution

estradiol

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lenzetto is and what it is used for
• 2. What you need to know before you use Lenzetto
• 3. How to use Lenzetto
• 4. Possible side effects
• 5. How to store Lenzetto
• 6. Contents of the pack and other information

1. What is Lenzetto and what is it used for

Lenzetto is a Hormone Replacement Therapy (HRT). It contains the female hormone estradiol of the
estrogen group. Lenzetto is used in women in post-menopause for at least 6 months after their
last natural cycle.
Lenzetto can also be used in women who have undergone surgical removal of the ovaries,
as this causes immediate menopause.
Lenzetto is a spray solution that contains small amounts of a medicine called estradiol.
When sprayed onto the skin according to the instructions, it passes through the skin into its bloodstream.
Lenzetto is used for:

Relief of symptoms that occur after menopause
During menopause, the amount of estrogen produced by a woman's body decreases. This can
cause symptoms such as flushing of the face, neck and chest (“hot flashes”). Lenzetto relieves these
symptoms after menopause. You will only be prescribed Lenzetto if your symptoms have a significant
negative impact on your daily life.
Lenzetto is indicated for treating the symptoms of estrogen deficiency after menopause; when
menstruations have ceased following menopause. Symptoms of estrogen deficiency include
hot flashes (sudden waves of heat and sweating all over the body), sleep problems,
irritability and vaginal dryness.
Experience in treating women over 65 years of age is limited.
Lenzetto is not a contraceptive.

2. What you need to know before using Lenzetto

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to use it, or to
continue using it.
Experience in the treatment of women with early menopause (due to ovarian insufficiency or to
surgery) is limited. If you have early menopause, the risks of using HRT may be different.
Talk to your doctor.
Before starting (or restarting) HRT, your doctor will ask you about your personal and family medical
history. Your doctor may decide to perform a medical examination. This may include a
breast exam and/or a pelvic exam, if necessary.
Once you have started therapy with Lenzetto, you should see your doctor for regular check-ups (at least once
a year). On these occasions, discuss with your doctor the benefits and risks of continuing therapy
with Lenzetto.
Undergo regular breast screenings, as recommended by your doctor.

Do not use Lenzetto
If any of the following apply to you. If you are not sure about any of the conditions described
below, talk to your doctorbefore using Lenzetto.
Do not use Lenzetto

• if you have or have ever had breast cancer, or if you suspect that you may have it;
• if you have estrogen-sensitive cancer,such as cancer of the uterine lining (endometrium), or if you suspect that you may have it;
• if you have any unexplained vaginal bleeding;
• if you have an excessive thickening of the uterine lining(endometrial hyperplasia) that has not been treated;
• if you have or have ever had a blood clot in a vein(thrombosis), for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if you have a disorder of blood coagulation (such as protein C deficiency, proteinS deficiency or antithrombin deficiency);
• if you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, strokeor angina;
• if you have or have ever had a liver diseaseand your liver function tests have not returned to normal;
• if you have a rare blood disorder called “porphyria” that runs in your family (is hereditary);
• if you are allergic(hypersensitive) to estradiol or to any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions appear for the first time during the use of Lenzetto,
stop using it immediately and consult your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before using Lenzetto.
Tell your doctor if you have ever had any of the following problems, before starting treatment,
as these may recur or worsen during treatment with Lenzetto. In this case, you should
see your doctor more often for check-ups:

• fibroids inside the uterus;
• growth of the uterine lining outside of it (endometriosis) or a history of excessive growth of the uterine lining (endometrial hyperplasia);
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)“);
• increased risk of developing an estrogen-sensitive cancer (e.g. if you have a mother, sister or grandmother who has had breast cancer);
• high blood pressure;
• a liver disorder such as a benign liver tumor;
• diabetes;
• gallstones;
• migraine or severe headache;
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE);
• epilepsy;
• asthma;
• a disease of the eardrum and hearing (otosclerosis);
• a very high level of fats in the blood (triglycerides);
• fluid retention due to heart or kidney problems.

Stop using Lenzetto and see your doctor immediately
If you notice any of the following conditions while using HRT:

• any of the conditions mentioned in the “DO NOT use Lenzetto” section
• yellowing of the eyes or skin. This could be a sign of liver problems (jaundice). These can be signs of a liver disease;
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• headaches similar to migraines that occur for the first time;
• if you become pregnant;
• if you notice signs of a blood clot such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing.

For more information, see “Blood clots in a vein (thrombosis)”.

Note:Lenzetto is not a contraceptive. If less than 12 months have passed since your last
menstrual period or if you are under 50 years of age, you may still need to use additional contraception to
prevent pregnancy. Ask your doctor for advice.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the

uterine lining (endometrial cancer).
The use of HRT based on estrogen alone will increase the risk of excessive thickening of the uterine lining
(endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer).
Taking a progestogen in addition to estrogen for at least 12 days of each 28-day cycle protects you from this additional risk. Therefore, if you still have a uterus, your doctor will prescribe
a progestogen separately. If you have had your uterus removed (hysterectomy), discuss with your doctor whether you can safely take
this product without a progestogen.
In women who still have a uterus and who do not use HRT, on average, 5 out of 1000 will be diagnosed
with endometrial cancer between the ages of 50 and 65.
For women between the ages of 50 and 65 who still have a uterus and who are taking HRT based on estrogen alone,
between 10 and 60 women out of 1000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 additional cases),
depending on the dose and duration of use.
Lenzetto contains a higher dose of estrogen than other estrogen-only HRT products. The risk of endometrial cancer during the use of Lenzetto together with a progestogen is not
known.

Unexpected bleeding
You will have a bleed once a month (so-called breakthrough bleeding) while using
Lenzetto if this is associated with a sequentially associated progestogen. However, if you have
unexpected bleeding or spotting outside of your monthly bleeding, which:

• continues for more than 6 months
• starts after you have been using Lenzetto for more than 6 months
• continues after you stop using Lenzetto see your doctor as soon as possible.

Breast cancer
Evidence suggests that the use of combined estrogen-progestogen therapy and possibly also estrogen-only HRT increases the risk of breast cancer. The additional risk depends on the duration of
HRT use. The additional risk becomes apparent within a few years. However, it returns to normal
within a few years (at most 5) after stopping treatment.
For women who have had their uterus removed and who have used estrogen-only HRT for 5 years, there is a small increase or no increase in the risk of breast cancer.
Comparison: For women between the ages of 50 and 79 who do not use HRT, an average of 9 to 17 out of 1000
will be diagnosed with breast cancer over a period of 5 years. For women between the ages of 50 and 79
who use combined estrogen-progestogen HRT over 5 years, there will be 13 to 23 cases out of 1000 users
(i.e. 4 to 6 additional cases).

Check your breasts regularly. See your doctor if you notice any changes such as:

• skin retraction
• changes in the nipple
• any lump you can see or feel.

In addition, it is recommended that you participate in mammography screening programs when they are offered. For
mammography screening, it is important that you inform the nurse/healthcare professional who will perform the X-ray examination that you are using HRT, as this medicine may increase the density of your breast, which
may affect the outcome of the mammography. When breast density is increased, mammography
may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between 50 and 54
years who do not use HRT, about 2 out of 2000 will be diagnosed with ovarian cancer
over a 5-year period. For women who are using HRT for 5 years, there will be about 3 cases out of
2000 women treated (i.e. about 1 additional case).

Effect of HRT on the heart and circulation

Blood clot in a vein (thrombosis)
The risk of blood clot in a veinis approximately 1.3-3 times higher in HRT users
compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one of them travels to the lungs, it can cause chest pain, shortness of breath, fainting and even death.
You are more likely to develop a blood clot in the veins as you get older and if any of the following apply to you. Tell your doctor if any of these situations apply to you:

• you are unable to walk for a long time due to major surgery, injury or illness (see also section 3, If you need surgery);
• you are severely overweight (BMI>30 kg/m²);
• you have a blood clotting disorder that requires long-term treatment with a medicine used to prevent blood clots;
• one of your close relatives has ever had a blood clot in the leg, lung or another organ;
• you have systemic lupus erythematosus (SLE);
• you have cancer.

For the signs of a blood clot, see “Stop using Lenzetto and see your doctor immediately”.
In 50-year-old women who do not use HRT, on average, over a 5-year period, between 4 and 7 out of 1000 are expected to
develop a blood clot in a vein.
In 50-year-old women who are using estrogen-only HRT for more than 5 years, there will be 9 to 12 cases out of 1000 users (i.e. 5 additional cases).
In 50-year-old women who have had their uterus removed and are using estrogen-only HRT for more than 5 years, there will be 5 to 8 cases out of 1000 users (i.e. 1 additional case).

Heart disease (heart attack)
There is no evidence that HRT prevents heart disease.
Women over 60 who use combined estrogen-progestogen HRT have a slightly
higher probability of developing heart disease compared to those who do not use any HRT.
For women who have had their uterus removed and who are using estrogen-only therapy, there is no
increased risk of developing heart disease.

Stroke
The risk of having a stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT increases with age.
Comparison: In 50-year-old women who do not use HRT, on average, 8 out of 1000 may
have a stroke over a 5-year period. For 50-year-old women who use combined estrogen-progestogen HRT over 5 years, there will be 11 cases out of
1000 users over 5 years (i.e. 3 additional cases).

Other conditions
HRT does not prevent memory loss. There is evidence of an increased risk of memory loss in women who start using HRT after the age of 65. Ask your doctor for advice.

Children
After the spray has dried, the application site should be covered with clothing if another
person may come into contact with that area of skin. The estrogen contained in the Lenzetto spray
may be accidentally transferred from the skin area where it was sprayed to other people. Do not
allow others, especially children, to come into contact with the skin area where you sprayed Lenzetto. If a child comes into contact with the arm area where Lenzetto was sprayed,
wash the child's skin with soap and water as soon as possible. Small children who have accidentally touched
women using Lenzetto in the exposed area for several times may show
unexpected signs of puberty (e.g. breast development).
Call your doctor immediately if you notice any signs or symptoms (breast development or other changes
sexual) in a child who may have been accidentally exposed to Lenzetto. In most
cases, the child's breast returns to normal when exposure to Lenzetto ceases.

Pets
Do not allow pets to lick or touch your arm where Lenzetto has been sprayed.
Small animals may be particularly sensitive to the estrogen contained in Lenzetto.
Contact a veterinarian if your pet shows signs of nipple and/or vulvar enlargement, or any other sign of illness.

Other medicines and Lenzetto
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Some medicines can interfere with the effect of Lenzetto. This could lead to bleeding

• medicines for epilepsy(such as phenobarbital, phenytoin and carbamazepine);
• medicines for tuberculosis(such as rifampicin, rifabutin);
• medicines for HIV infection(such as nevirapine, efavirenz, ritonavir and nelfinavir);
• herbal remedies containing St John's Wort( Hypericum perforatum).

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicine, including those obtained without a prescription, herbal medicines or other natural products.

Diagnostic tests
If you need a blood test, tell your doctor or laboratory personnel that you are using
Lenzetto because this medicine can affect the results of some tests.

Pregnancy and breastfeeding
The use of Lenzetto is only for postmenopausal women. If you become pregnant, stop using
Lenzetto and contact your doctor.
Do not use Lenzetto during breastfeeding.

Driving and operating machinery
Lenzetto has no effect on the ability to drive vehicles or operate machinery.

Lenzetto contains alcohol
Alcohol-based liquids are flammable. Avoid fire, flames or smoking while applying the
spray to the skin, until the spray has dried.

3. How to use Lenzetto

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will aim to prescribe the lowest dose to treat your symptoms for the shortest time
necessary. During treatment, the doctor may adjust the dose based on your individual needs.
Talk to your doctor if you think this dose is too strong or not strong enough.
If you have not had a hysterectomy (surgery to remove the uterus), your doctor will give you tablets
containing another hormone called progesterone to compensate for the effects of estrogens on the
uterine lining. Your doctor will explain how to take these tablets. At the end of the treatment period
with the progestin, withdrawal bleeding may occur. (See the paragraph "
Unexpected bleeding").

If you need surgery
If you are about to have surgery, tell the surgeon that you are using Lenzetto. You may need to
stop using Lenzetto approximately 4-6 weeks before the operation to reduce the risk of a
blood clot (see paragraph 2, Blood clots in a vein). Ask your doctor when you can
start using Lenzetto again.

Where to apply Lenzetto
The spray must be applied to dry and healthy skin of the inner forearm. If this is not
possible, it must be applied to the inner thigh.

Do not apply Lenzetto to the breast or to any area near the breast.

How to apply Lenzetto

Before using a new applicator for the first time, the pump must be primed
by spraying 3 times with the cap still closed:
The container must be held upright as shown in Figure 1. With the cap still
closed, press the button down 3 times with your thumb or index finger.
Now the medicine is ready for use.
DO NOT prime the applicator before each administration; prime the applicator only once
before starting to use a new container. If you skip one or more doses, prime the applicator according to
the instructions provided in the paragraph “If you forget to use Lenzetto”.
Hold in a vertical position
Figure 1

Make sure the skin on which you intend to spray the medicine is healthy, clean and dry.

How to apply the daily dose.

Figure 2
To apply the daily dose, remove the plastic cap, hold the container upright and place the flat plastic cone against the skin. (Figure 2)
You may need to move your arm or move the conical part of the container on your arm so
that the cone is flat against the skin and there are no gaps between the cone and the skin.
Press the actuator button down once. You must press it all the way downand hold it down
before releasing.
If a second spray is needed, move the cone along your arm so that it is near the area
where you have already sprayed. Press the button down once.
If a third spray is needed, move the cone along your arm again and press the button down once.
Figure 3
If the second or third spray cannot be done on the same inner forearm, you can also use
the spray on the other inner forearm. If you have difficulty positioning the cone on the inner forearms
as shown in Figure 3 or if it is difficult for you to use it on the forearms, you can also use the spray
on the inner surface of the thigh.
When you have finished using Lenzetto, always put the cap back on the container (Figure 4).
If you use the product according to the instructions, regardless of the shape or type of different spray pattern on the skin, each spray will release the same amount of active ingredient on the skin.
Let the spray dry for at least 2minutes before dressing and for at least 60minutes before bathing or washing. If Lenzetto spray gets on another area of your skin, such as your hands, wash
the area of skin immediately with water and soap.
Lenzetto should not be used on wounded or damaged skin.
Do not massage or rub Lenzetto into the skin.

Do not let other people or pets touch the area of skin where the spray has been
applied for at least 60 minutes.If another person (especially a child) accidentally touches
the area of your skin where you have sprayed Lenzetto, tell them to wash the area of
their skin immediately with water and soap. Therefore, the sprayed area must be covered with clothing 2
minutes after applying the spray.

How much Lenzetto to use
The doctor will probably start you on the lowest dose (one spray a day) and you should report
to the doctor if the medicine is working. If necessary, the doctor may increase the dose to two
sprays a day. The maximum daily dose is 3 sprays.

How often you will need to use Lenzetto
The total number of sprays (doses) that your doctor has prescribed must be applied at the same
time each day.

Period of time for which you will need to continue using Lenzetto
Discuss with your doctor every 3-6 months about the duration of use of Lenzetto. You should use Lenzetto only for the
time necessary to provide relief from hot flashes associated with menopause.

Other useful information
Sunscreens can alter the absorption of estrogen from Lenzetto.
Avoid using sunscreens on the part of the skin where you intend to spray Lenzetto. However, if you
need to use a sunscreen, you should apply it at least one hour before using Lenzetto.
Lenzetto should be used with caution in conditions of extreme temperature, such as a sauna or exposure
to the sun.
There are limited data on whether the rate and extent of Lenzetto absorption may be reduced
in obese or overweight women. Contact your doctor. During treatment with Lenzetto, the doctor
may adjust the dose based on your individual needs.

If you use more Lenzetto than you should
If you use more Lenzetto than you should, or if children have accidentally used the medicine, contact
your doctor or hospital immediately for advice on the risks and advice on what to do.
If you use more Lenzetto than you should, you may experience nausea, vomiting, and withdrawal bleeding
(unusual vaginal bleeding).

If you forget to use Lenzetto
If you forget to use Lenzetto at the usual time, spray the medicine as soon as you remember and then
use it the next day as you normally would. If it is almost time for the next dose, wait and
apply the next dose as you normally would. If you forget one or more doses, you must
prime the pump by spraying into the cap. Do not use a double dose to make up for a missed dose.
Forgetting a dose may increase the likelihood of withdrawal bleeding and spotting.
If you have any questions about using this medicine, ask your doctor or pharmacist.

If you stop using Lenzetto
The doctor will also explain how to stop using this medicine when the treatment is
finished.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions have been reported more often in women using TOS than in women who do not
use it:

• breast cancer
• abnormal growth or cancer of the uterine lining (hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• gallbladder disease
• high blood pressure
• liver problems
• high blood sugar levels
• probable memory loss if TOS is started after the age of 65.

For more information about these side effects, see section 2.
Some side effects can be serious.
The following symptoms require immediate medical attention:

• sudden chest pain;
• chest pain that spreads to the arm or neck;
• difficulty breathing;
• painful swelling or redness of the legs;
• yellowing of the eyes and skin (jaundice);
• unexpected vaginal bleeding (breakthrough bleeding) or spotting after using Lenzetto for some time or after stopping treatment;
• changes in the breasts including skin retraction of the breast, changes of the nipple, lumps that you can see or feel;
• painful menstrual periods;
• dizziness and fainting;
• changes in speech;
• changes in vision;
• unexplained headaches such as migraines.

If any of these side effects get worse or if you notice any side effect not listed
With Lenzetto the following side effects have been reported:

Common side effects(may affect up to 1 in 10 people):
Headache, abdominal pain, nausea, rash, itching, irregular uterine bleeding or
vaginal bleeding including spotting, breast tenderness, breast pain, weight gain or loss.

Uncommon side effects(may affect up to 1 in 100 people):
Hypersensitivity reactions, depressed mood, insomnia (difficulty sleeping), dizziness, vertigo (a
sensation of spinning or “lightheadedness”), visual disturbances, palpitations (feeling your heartbeat),
diarrhea, dyspepsia (indigestion), increased blood pressure, erythema nodosum (characterized by
reddened and painful skin nodules), urticaria (rash or generalized or localized bumps), skin irritation
due to fluid retention (edema), muscle pain, change in breast color, breast discharge, polyps (small growths) in the uterus or cervix, endometrial hyperplasia, ovarian cyst, inflammation of the genitals (vaginitis), increased liver enzymes and
cholesterol in the blood, pain under the arm.

Rare side effects(may affect up to 1 in 1000 people):
Anxiety, decreased or increased sexual drive, migraine, contact lens intolerance, swelling,
vomiting, increased body hair, acne, muscle cramps, painful menstruation, premenstrual-like
syndrome, breast enlargement, fatigue.

Other side effectswith “not known” frequency (frequency cannot be estimated on the basis
of available data) have been reported with Lenzetto during post-marketing surveillance: hair loss (alopecia), chloasma (brown-gold pigmented spots, called “pregnancy spots”,
especially on the face), skin color change.

The following side effects have been reported with other TOS:
Severe allergic reaction causing swelling of the face or throat (angioedema), anaphylactoid/anaphylactic reactions (severe allergic reaction causing difficulty breathing or dizziness),
glucose intolerance, depression, mood disorders, irritability, exacerbation of chorea (St. Vitus’ dance), exacerbation of epilepsy, dementia, exacerbation of asthma, gallbladder disease,
yellowing of the skin (jaundice), inflammation of the pancreas, benign neoplasm of the smooth muscle
of the uterus, various skin disorders: skin color change especially of the face or neck
known as “pregnancy spots” (chloasma); reddened and painful nodules (erythema nodosum); rash with
redness or target-shaped sores (erythema multiforme), hemorrhagic rash, hair loss, pain in a joint, breast milk secretion, breast lumps, increase in the size
of benign smooth muscle neoplasm of the uterus, change in secretion and inner lining
of the cervix (“neck” of the uterus), inflammation of the vagina, fungal infections in the vagina
(vaginal candidiasis), abnormally low levels of calcium in the blood.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lenzetto

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
container. The expiry date refers to the last day of that month. Use within 56 days of
first use.
Do not refrigerate or freeze this medicine.
Do not store at a temperature above 25°C.
This medicine contains ethanol which is flammable. Keep away from sources of heat, open flames
or other sources of ignition.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lenzetto contains

• The active ingredient is estradiol (as estradiol hemihydrate). Each spray delivers 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).
• The other ingredients are octisalate and 96% ethanol.

Description of Lenzetto and contents of the pack
Lenzetto is a transdermal spray containing a solution of estradiol and octisalate in ethanol. It is
supplied with a dosing pump.
Lenzetto is supplied in a plastic container with a plastic cap. Inside there is a
glass container containing 8.1 ml of solution and is designed to deliver 56 sprays of
90 microliters after priming. Mark the number of sprays using the table on the carton.
Each spray contains 1.53 mg of estradiol.
Do not use each Lenzetto container for a number of sprays greater than that indicated on the
label even if the bottle may not be completely empty.
Pack sizes:
1 plastic container of 8.1 ml (56 sprays)
3 plastic containers of 3x8.1 ml (3x56 sprays).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21,
H-1103 Budapest
Hungary

Manufacturer:
Gedeon Richter România S.A.
Cuza Vodă street 99-105
Târgu-Mureş
Romania – 540306
Gedeon Richter Plc.
Esztergomi út 27
2510 Dorog
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the
following names: