Nicovel Mint 2 mg Munhålepulver i portionspåse

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

05-07-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
nikotin
Tillgänglig från:
Orifarm Generics A/S, c/o Orifarm Generics A/S
ATC-kod:
N07BA01
INN (International namn):
nicotine
Dos:
2 mg
Läkemedelsform:
Munhålepulver i portionspåse
Sammansättning:
nikotin 2 mg Aktiv substans
Receptbelagda typ:
Receptfritt
Produktsammanfattning:
Förpacknings: Burk, 20 portionspåsar (i aluminiumpåse)
Bemyndigande status:
Godkänd
Godkännandenummer:
55117
Tillstånd datum:
2017-09-06

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

29-05-2018

Produktens egenskaper Produktens egenskaper - engelska

29-06-2017

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

06-09-2017

Läs hela dokumentet

Package leaflet: Information for the user

Nicovel Mint 2 mg oromucosal powder in pouch

Nicovel Mint 4 mg oromucosal powder in pouch

nicotine

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told

you.

Keep this leaflet. You may need to read it again.

Ask you pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

You must talk to a doctor or pharmacist if you have used Nicovel Mint for more than 6 months.

What is in this leaflet

What Nicovel Mint is and what it is used for

What you need to know before you use Nicovel Mint

How to use Nicovel Mint

Possible side effects

How to store Nicovel Mint

Contents of the pack and other information

1. What Nicovel Mint is and what is it used for

Nicovel Mint contains the active substance nicotine. It relieves craving for nicotine and withdrawal

symptoms when you stop smoking and thereby counteracts relapse to smoking in smokers who are motivated

to stop.

Nicovel Mint facilitates smoking reduction in smokers who cannot or are unwilling to stop smoking

completely.

It is indicated for adults aged 18 years and above.

When you suddenly stop providing nicotine in the form of tobacco to your body, you experience different

kinds of discomfort, called withdrawal symptoms. When using Nicovel Mint you can prevent or reduce this

discomfort, by continuing to provide a small amount of nicotine to your body during a transitional period.

Advice and support may help you to improve the success rate.

You must talk to a doctor or pharmacist if you have used Nicovel Mint for more than 6 months.

2. What you need to know before you use Nicovel Mint

Do not use Nicovel Mint:

if you are

allergic

to nicotine or any of the other ingredients of this medicine (listed in section 6).

if you suffer from severe

heart disease

(e.g. unstable angina pectoris, severe arrhythmia).

if you have recently had a

heart attack

(within 3 months) or

stroke

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Nicovel Mint if you have

any of the following. You

might still be able to use Nicovel Mint, but need to discuss with your doctor first if you have:

chest pain

(unstable angina), or

resting angina

heart condition

that effects your heart rate or rhythm

high blood pressure

which is not being controlled by medicines

ever had

allergic reactions

that involved swelling of the lips, face and throat (angioedema) or

itchy

skin rash

(urticarial). Using nicotine replacement therapy can sometimes trigger this type of reaction

moderate to severe

liver disease

severe

kidney disease

stomach or duodenal ulcer

hyperactive

thyroid gland

a tumor of the

adrenal gland

(phaeochromocytoma)

diabetes

and use insulin as you may require lower doses of insulin

inflammation of the gullet

(oesophagitis)

Children and adolescents

Children and adolescents under 18 years of age should not use Nicovel Mint, unless prescribed by a doctor.

A normal dose for adults could seriously poison or even kill a small child. It is therefore important that you

keep Nicovel Mint out of the sight and reach of children at all times.

Other medicines and Nicovel Mint

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

This is specially important if you use other medicines that contain

theophylline (to treat asthma)

tacrine (for Alzheimer’s disease)

clozapine (for schizophrenia)

ropinirole (to treat Parkinson’s disease)

Nicovel Mint with food and drink

You should not eat or drink with the pouch in your mouth, since this may decrease the effect of Nicovel

Mint.

Acidic drinks ( e.g. coffee, fruit juice, or soda) may reduce the uptake of nicotine in the mouth cavity.

To make sure that the best effect will be achieved, you should avoid these drinks within approximately 15

minutes before using Nicovel Mint.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feding, think you may be pregnant or are planning to have a baby, ask your

doctor or pharmacist for advice before using this medicine.

It is very important to stop smoking during pregnancy since smoking can result in poor growth of your baby.

It can also lead to premature births and even stillbirths. Ideally you should stop smoking without the use of

medicines containing nicotine. If you cannot manage this, Nicovel Mint should only be used after consulting

the healthcare professional who is managing your pregnancy, your doctor, or a doctor that is specialised in

helping people quit smoking.

Nicovel Mint should be avoided during breast-feeding as nicotine passes into breast milk and this may affect

your child. If your doctor has recommended you to use Nicovel Mint during breast-feeding, it should be

taken immediately after breastfeeding and not within two hours before breastfeeding.

Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility is unknown.

Driving and using machines

Nicovel Mint has no or negligible influence on the ability to drive and use machines.

3. How to use Nicovel Mint

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told

you. Check with your doctor or pharmacist if you are not sure.

The recommended dose at the beginning of the treatment is 1 pouch to be used every to every second hour.

8 -12 pouches per day is normally sufficient. Do not use more than 24 pouches per day.

Opening instructions:

Press onto the box just below the lid.

Lift the lid.

Place the pouch under the upper lip and keep it there for approximately 30 minutes. Occasionally move the

pouch around with the tongue.

The onset of effect when using Nicovel Mint is not as fast as when smoking and therefore you cannot expect

to experience the same rapid satisfaction as when smoking.

Do not use Nicovel Mint for more than 6 months without consulting your doctor or pharmacist. Regular use

of Nicovel Mint for more than 1 year is generally not recommended.

Smoking cessation

The duration of treatment is individual, but should normally continue for at least 3 months. Thereafter the

number of pouches per day should be reduced gradually. Therapy should be stopped when the dose has been

decreased to 1-2 pouches per day. You may however use a pouch when you are tempted to smoke.

Smoking reduction

Nicovel Mint can be used in between periods of smoking, in order to prolong smoking–free intervals with

the intention to reduce smoking as much as possible. If you, after 6 weeks, have not succeeded to cut down

the number of cigarettes per day you should seek professional help. You should try to stop smoking as soon

as you feel motivated, however no later than 6 months after you started to use Nicovel Mint. If you do not

succeed to make a serious attempt to stop smoking within 9 months you should seek professional help.

Children and adolescents

Adolescents under 18 years of age should not use Nicovel Mint, unless prescribed by a doctor.

If you use more Nicovel Mint than you should

Overdose with nicotine could occur if you are only used to low doses of nicotine or if you smoke when using

Nicovel Mint.

The symptoms of overdose include nausea, salivation, abdominal pain, diarrhoea, sweating, headache,

dizziness, hearing disturbances and pronounced weakness (feeling of weakness). At high doses, these

symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty in breathing, extreme

tiredness, circulatory collapse and general convulsions.

If a child takes Nicovel Mint or if you use too much nicotine, contact your doctor or the emergency

department at the hospital immediately for evaluation of risk and for advice.

If you have any further questions on the use of this medicine, please contact you doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Nicovel Mint may cause the same side effects as nicotine administered in other forms. Side effects are

generally dose dependent. See also section “If you use more Nicovel Mint than you should.”

Stop

taking Nicovel Mint and contact a doctor or go to the nearest emergency department

immediately

you experience any of the following symptoms of allergic reactions, which can be serious, such as

angioedema. These are rare side effects (may affect up to 1 in 1000 people):

swollen face, tongue or throat

difficulty to swallow

hives and difficulties to breathe

Other side effects that may occur:

Common: may affect up to 1 in 10 people

dizziness, headache

gastrointestinal discomfort, hiccups, nausea, vomiting

irritated mouth or throat

Uncommon: may affect up to 1 in 100 people

palpitations (feeling fast or irregular heartbeat),

skin redness and hives

Rare: may affect up to 1 in 1,000 people

disturbances in heartbeat

Some symptoms such as dizziness, headache and sleeping disturbances may be caused by withdrawal

symptoms during smoking cessation and are caused by a decreased supply of nicotine.

Canker sores (painful ulcers in the mucosa of the mouth) can appear when you stop smoking but the

connection to smoking cessation is unclear.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects

you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Nicovel Mint

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

Keep the container tightly closed in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the envelope and container after EXP. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nicovel Mint contains

The active substance is nicotine. One pouch contains 2 or 4 mg nicotine.

The other ingredients are: alginic acid, anhydrous sodium carbonate, copovidone, powdered cellulose,

peppermint flavour and neohesperidin dihydrochalcone.

What Nicovel Mint looks like and the contents of the pack

Nicovel Mint is a rectangular pouch filled with powder.

Package size:

20 pouches in a polypropene container with a lid in a laminated aluminium envelope.The pouch is made of

non-woven fabric composed of viscose and an acrylic binder.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in 2018-05-29

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Nicovel Mint 2 mg oromucosal powder in pouch.

Nicovel Mint 4 mg oromucosal powder in pouch.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicovel Mint 2 mg: One pouch contains 2 mg nicotine.

Nicovel Mint 4 mg: One pouch contains 4 mg nicotine.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Oromucosal powder in pouch

Rectangular pouch filled with powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Nicovel Mint oromucosal powder in pouch is indicated in adults for the treatment of tobacco

dependence by relieving nicotine craving and withdrawal symptoms.

Nicovel Mint facilitates smoking cessation in smokers who are motivated to quit and facilitates

smoking reduction in smokers who are not able or willing to quit smoking. Nicovel Mint oromucosal

powder in pouch should preferably be used in conjunction with a behavioural support program.

4.2

Posology and method of administration

Posology

Adults and elderly

Initially, one pouch may be administered every 1-2 hours. The usual dosage is 8-12 pouches a day.

The maximum daily dose is 24 pouches.

Smoking cessation

The duration of treatment is individual. Normally, the treatment should continue for at least 3 months.

The nicotine dose should then be gradually reduced. Treatment should be discontinued when the dose

has been reduced to 1-2 pouches per day. Regular use of Nicovel Mint for more than one year is

generally not recommended. In some cases a longer treatment period might be necessary in order to

avoid relapse. Any spare pouches should be retained, as craving may suddenly occur.

Counselling and support may increase the probability to succeed in quitting smoking.

Smoking reduction

Nicovel Mint is used between periods of smoking in order to extend the non-smoking intervals and

with the objective to reduce smoking as much as possible. Professional help should be sought if a

decrease in number of cigarettes per day has not been achieved after 6 weeks of treatment.

An attempt to quit smoking should be made as soon as the smoker is motivated, however no later than

6 months after treatment start. Professional help should be sought if it is not possible to make a serious

attempt to quit smoking within 9 months after treatment start. Regular use of Nicovel Mint for more

than 1 year is generally not recommended. Some ex- smokers may need treatment for a longer period

in order to avoid relapse. Any spare pouches should be retained, as craving may suddenly occur.

Renal and hepatic impairment

See section 4.4.

Paediatric population

The safety and efficacy of Nicovel Mint in children and adolescents below 18 years of age has

not been established. Nicovel Mint should not be administered to adolescents below 18 years

of age without recommendation from a physician.

Method of administration

The user should not eat or drink while using the pouch. Liquids that decrease the pH in the oral cavity,

e.g. coffee, fruit juice or sodas, may reduce the buccal absorption of nicotine. To achieve maximum

absorption of nicotine, these liquids should be avoided for up to 15 minutes prior to using the pouch.

One pouch is placed under the upper lip for 30 minutes. In order to increase the release of nicotine the

pouch can occasionally be moved around with the tongue.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Recent myocardial infarction (within 3 months).

Unstable or progressive angina pectoris.

Prinzmetal’s variant angina.

Severe cardiac arrhythmias.

Stroke in acute phase.

4.4

Special warnings and precautions for use

The benefits of quitting smoking usually outweigh any risk associated with correctly administered

nicotine replacement therapy (NRT).

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with

the following conditions:

Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or

worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent

cerebrovascular accident and/or who suffer with uncontrolled hypertension should be encouraged

to stop smoking with non-pharmacological interventions (such as counselling). If this fails,

Nicovel Mint may be considered but as data on safety in this patient group are limited, initiation

should only be under close medical supervision.

Allergic reactions: Susceptibility to angioedema and urticaria.

Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic

impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be

decreased with the potential for increased adverse effects.

Gastrointestinal Disease: Swallowed nicotine may exacerbate symptoms in patients suffering

from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution

in these conditions.

Phaeochromocytoma and uncontrolled hyperthyroidism: Nicotine, both from nicotine

replacement therapy and from smoking, causes release of catecholamines from the adrenal

medulla. Therefore Nicovel Mint should also be used with caution in patients with

hyperthyroidism or phaeochromocytoma.

Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar

levels more closely than usual when smoking is stopped and NRT is initiated as reduction in

nicotine-induced catecholamine release can affect carbohydrate metabolism.

Continued nicotine dependence may occur but to a lower extent. The use of nicotine itself is however

less harmful than smoking/use of tobacco.

Paediatric population

Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that

may be fatal. Products containing nicotine should not be left where they may be handled or ingested

by children, see section 4.9 Overdose.

4.5

Interaction with other medicinal products and other forms of interaction

Smoking, (but not nicotine), is associated with increased activity of CYP1A2. After smoking

cessation, clearance may be reduced for certain medicines that are metabolised via CYP1A2. This may

lead to an increase in plasma levels for some medicinal products. The increase may have a potential

clinical importance for products with a narrow therapeutic window, e.g. theophylline, tacrine,

clozapine, and ropinirole.

The plasma levels of other drugs partly metabolised via CYP1A2 e.g. imipramine, olanzapine,

clomipramine and fluvoxamine may also increase on cessation of smoking. Data to support this are

however lacking and the possible clinical significance of this effect for these drugs is unknown.

Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by

smoking.

4.6

Fertility, pregnancy and lactation

Pregnancy

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature

birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health

of both the pregnant smoker and her baby. The earlier abstinence is achieved the better.

Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the

circulation is dose-dependent.

The pregnant smoker should therefore always be advised to stop smoking completely without use of

nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus

compared with the use of nicotine replacement products in a supervised smoking cessation

programme. Use of Nicovel Mint by the pregnant smokers should only be initiated after advice from a

health care professional.

Lactation

Nicotine passes freely into breast milk in quantities that may affect the child even with therapeutic

doses. Nicovel Mint should therefore be avoided during breast-feeding.

Should smoking withdrawal not be achieved, use of Nicovel Mint by breast feeding smokers should

only be initiated after advice from a health care professional. If nicotine replacement therapy is used

whilst breast-feeding Nicovel Mint should be taken immediately after breast feeding and not within

two hours before breast feeding.

Fertility

Smoking increases the risk for infertility in woman and men. In vitro studies have shown that nicotine

can adversely affect human sperm quality. In rats, impaired sperm quality and reduced fertility have

been shown.

4.7

Effects on ability to drive and use machines

Nicovel Mint has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

Nicovel Mint may cause adverse events similar to those associated with nicotine administered by other

means. The adverse events are dose dependent. Most adverse events reported by patients usually occur

during the first 3-4 weeks after treatment start.

Frequency of adverse events according to MedDRA-system organ class database.

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000

to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data) .

System organ class

Undesirable effects

Nervous system disorders

Common

Dizziness, headache

Cardiac disorders

Uncommon

Rare

Palpitations

Atrial fibrillation

Gastrointestinal disorders

Common

Gastrointestinal discomfort, hiccups, nausea,

vomiting.

Skin and subcutaneous tissue disorders

Uncommon

Erythema, hives

General disorders and administration site

conditions

Common

Rare

Irritated mouth or throat

Allergic reaction such as e.g. angioedema

Some symptoms, such as dizziness, headache and insomnia, which have been reported may be related

to withdrawal symptoms associated with smoking cessation. Increased frequency of aphtous ulcers

may occur when smoking is stopped. The causality is unclear.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in

[To be completed nationally]

4.9

Overdose

Symptoms of overdose with nicotine may occur in patients with low pre-treatment nicotine intake or if

other sources of nicotine are used concomitantly.

Symptoms of overdose are those of acute nicotine poisoning and include nausea, salivation, abdominal

pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and pronounced weakness. At high

doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing

difficulties, fatigue, circulatory collapse and general convulsions.

Doses of nicotine that are tolerated by adult smokers during on-going treatment may cause severe

symptoms of poisoning in small children and may prove fatal.

Management of overdose: Administration of nicotine must be stopped immediately and the patient

should be treated symptomatically. Activated charcoal reduces the gastrointestinal absorption of

nicotine.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC kod: N07BA01

Abrupt cessation of the use of tobacco-containing products following a prolonged period of daily use

may result in characteristic withdrawal symptoms that include four or more of the following:

dysphoria or depressed mood, insomnia, irritability, frustration or aggression, anxiety, difficulty

concentrating, restlessness or impatience, decreased heart rate, increased appetite or weight gain.

Nicotine craving, which is recognised as a clinically relevant symptom, is also an important element in

nicotine withdrawal. Clinical studies have shown that nicotine replacement products can help smokers

abstain from smoking by relieving these withdrawal symptoms.

A 6 week smoking cessation and tolerability study including 48 subjects was performed with

ad

libitum

use of nicotine 4 mg oromucosal powder in pouch. The number of pouches used per week

showed an average reduction of 56% and the total time of use was reduced by 44% compared with

baseline. During the 6 week study period the number of subjects with lesions associated with smoking

decreased. No subject developed any specific lesion at the site where the nicotine pouch was placed.

5.2

Pharmacokinetic properties

Absorption

The amount of released nicotine that is absorbed from a nicotine pouch depends on the amount of

nicotine released in the oral cavity and the amount that is swallowed. The main part of nicotine that is

released is absorbed through the buccal mucosa. The systemic bioavailability of swallowed nicotine is

lower due to first- passage elimination. The high and rapidly rising nicotine concentrations observed

after smoking are rarely reached after treatment with the pouch.

Maximal blood concentration is achieved after 30 minutes of use and is then comparable to the

concentration, appearing 20-30 minutes after smoking a cigarette (medium strength).

Distribution

The volume of distribution following i.v. administration of nicotine is about (2-) 3 l/kg. Plasma

protein binding for nicotine is less than 5 %. Other diseases or concomitant use of other drugs which

influence levels of plasma proteins are not expected to have any significant effect on the kinetics of

nicotine.

Metabolism

Nicotine is metabolized mainly in the liver and plasma clearance is in average about 70 l/ hour.

Nicotine is metabolized also in kidneys and lungs. More than 20 metabolites have been identified, and

all are believed to be less active than nicotine. The primary metabolite is cotinine which has a half-life

of 15-20 hours and which produces approximately 10 times higher plasma concentrations than

nicotine.

Elimination

The major metabolites in urine are cotinine (15 % of the dose) and trans-3-hydroxycotinin (45% of the

dose). About 10% of nicotine is excreted unchanged in the urine. As much as 30% of nicotine may be

excreted in the urine at increased diuresia and acidification of the urine below pH 5.

The half-life of nicotine is approximately 2 hours.

Special populations

Heavily impaired kidney function is assumed to exert influence on total clearance of nicotine.

The pharmacokinetics of nicotine are unaffected in cirrhotic patients with mild liver impairment (Child

score 5) and decreased in liver cirrhosis patients with moderate liver impairment (Child score 7).

Increased nicotine levels have been observed in smoking haemodialysis patients.

Minor reduction of total clearance of nicotine has been demonstrated in healthy, elderly users,

however, adjusting of the dose is not necessary.

No differences in nicotine kinetics have been observed between males and females.

5.3

Preclinical safety data

Nicotine was positive in some

in vitro

genotoxicity tests but there are also negative results with the

same test systems. Nicotine was negative in

in vivo

tests.

Animal experiments have shown that nicotine exposure results in decreased birth weight, decreased

litter size and decreased survival of off-spring.

The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of

nicotine.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Alginic acid

Sodium carbonate, anhydrous

Copovidone

Cellulose, powdered

Peppermint flavour

Neohesperidin dihydrochalcone

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

2 years

6.4

Special precautions for storage

Keep the container tightly closed in order to protect from moisture.

6.5

Nature and contents of container

20 pouches in a polypropene container with a lid in a laminated aluminium envelope. The pouch is

made of non-woven fabric composed of viscose and an acrylic binder.

6.6

Special precautions for disposal and other handling

No special requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

10.

DATE OF REVISION OF THE TEXT

29 June 2017

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