ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
REGRANEX 0.01% gel
2.
Each gram of gel contains 100 μg of becaplermin*.
* Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in
Saccharomyces cerevisiae
by recombinant DNA technology.
Excipients:
Each gram contains E218 (methyl parahydroxybenzoate) 1.56 mg and E216 (propyl
parahydroxybenzoate) 0.17 mg, see section 4.4.
For a full list of excipients, see section 6.1.
3.
Gel.
REGRANEX is a clear colourless to straw-coloured gel.
4.
REGRANEX is indicated, in association with other good wound care measures, to promote
granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than
or equal to 5 cm
2
.
Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non-
specialists) who are experienced in the management of diabetic wounds.
REGRANEX should always be used in conjunction with good wound care consisting of initial
debridement (to remove all the necrotic and/or infected tissue), additional debridement as necessary
and a non-weight-bearing regimen to alleviate pressure on the ulcer.
REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using
a clean application aid. The site(s) of application should then be covered by a moist saline gauze dressing
that maintains a moist wound-healing environment. REGRANEX should not be used in conjunction with
occlusive dressings.
-
A tube of REGRANEX should be used on a single patient only.
-
Care should be taken during use to avoid microbial contamination and spoilage.
-
The tip of the tube should not come into contact with the wound or any other surface.
-
The use of a clean application aid is recommended and contact with other parts of the body should
be avoided.
-
Before each application, the ulcer should be gently rinsed with saline or water to remove residual
gel.
-
The tube should be closed tightly after each use.
2
-
Hands should be washed thoroughly before applying REGRANEX.
REGRANEX should not be used for more than 20 weeks.
If during treatment with REGRANEX no meaningful healing progress is evident after the first ten
weeks of continuous therapy, treatment should be re-evaluated, and factors known to compromise
healing (such as osteomyelitis, ischaemia, infection) should be re-assessed. Therapy should be
continued to the maximum of 20 weeks as long as healing progress is seen on periodic evaluations.
Special population
Paediatric population
Safety and effectiveness in children and adolescents below the age of 18 years have not been
established.
-
Hypersensitivity to the active substance or to any of the excipients.
-
Any known malignancies (See section 4.4).
-
In patients with clinically infected ulcers. (See section 4.4).
Malignancies distant from the site of application have occurred in becaplermin users in both clinical
trial and in post-marketing use. In view of these data and since becaplermin is a growth factor,
Regranex treatment is contraindicated in patients with any known malignancies.
Prior to the use of REGRANEX, related underlying conditions such as osteomyelitis and peripheral
arteriopathy should be excluded or treated if present. Osteomyelitis should be assessed by X-ray
examination. Peripheral arteriopathy should be excluded by assessment of the pedal pulses or other
techniques. Ulcers with a suspicious appearance should be biopsied to exclude malignancy.
Wound infection should be treated prior to the use of REGRANEX. If a wound becomes infected
during REGRANEX therapy, the product should be discontinued until the infection has cleared.
REGRANEX should not be used in patients with ulcers that are not of primarily neuropathic origin, such
as those due to arteriopathy or other factors.
REGRANEX should not be used in ulcers of baseline surface area > 5 cm
2
, or for more than 20 weeks in
any individual. There are insufficient data to support safe use of the product for more than 20 weeks
(see 5.1 Pharmacodynamic properties). Efficacy has not been demonstrated for ulcers of baseline surface
area > 5 cm
2
.
REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
These may cause allergic reactions (possibly delayed).
No interaction studies have been performed. Consequently, it is recommended that REGRANEX should
not be applied to the ulcer site in conjunction with other topical medications.
Pregnancy
There are no adequate data from the use of becaplermin in pregnant women. Consequently,
REGRANEX should not be used during pregnancy.
3
Breastfeeding
It is not known whether becaplermin is excreted in human milk. Therefore, REGRANEX should not be
used during breastfeeding.
No studies on the effects on the ability to drive and use machines have been performed.
The safety of REGRANEX Gel was evaluated in 1883 adult patients who participated in 17 clinical
trials of REGRANEX and placebo and/or standard therapy (saline dressing). These 1883 patients had
at least one topical administration of REGRANEX and provided safety data. Based on pooled safety
data from these clinical trials, the most commonly reported (≥5% incidence) adverse drug reactions
(ADRs) were (with % incidence) infected skin ulcer (12.3), cellulitis (10.3), and osteomyelitis (7.2).
Including the above-mentioned ADRs, the following table displays ADRs that have been reported with
the use of REGRANEX from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention: very common (≥1/10); common
(≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare
(<1/10,000); not known (cannot be estimated from the available clinical trial data).
Adverse Drug R
eactions Reported in Clinical Trials and Postmarketing Experience
System Organ Class
Adverse Drug Reactions
Frequency Category
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)
Infections and Infestations
Infected skin
ulcer,Cellulitis
Osteomyelitis
Nervous System Disorders
Burning sensation
1
Skin and Subcutaneous
Tissue Disorders
Rash, Erythema
2
Dermatitis bullous,
Excessive granulation
tissue
General Disorders and
Administration Site
Conditions
Pain
Oedema
1.
The bundled term burning sensation consists of the preferred terms burning sensation, skin
burning sensation, and application site irritation, all of which referred specifically to burning at
the application site.
2.
Refers to erythema at the application site.
There are limited data on the effects of becaplermin overdose. Since there was no consistent increase
in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentrations,
following 14 consecutive daily topical applications to ulcers, no untoward systemic events are
expected.
5.
5.1
Pharmacodynamicproperties
Pharmacotherapeutic group:
Preparation for treatment of wounds and ulcers,
ATC code: D 03 AX06
4
REGRANEX contains becaplermin, a recombinant human Platelet Derived Growth Factor-BB
(rhPDGF-BB). Becaplermin is produced by insertion of the gene for the B chain of human platelet
derived growth factor into the yeast,
Saccharomyces cerevisiae
. The biological activity of becaplermin
includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair. Thus
it helps the growth of normal tissue for healing. In animal wound models, the predominant effect of
becaplermin is to enhance the formation of granulation tissue. From data combined from 4 clinical trials
conducted over a 20 week treatment phase for ulcers of baseline surface area less than or equal to
5 cm
2
, 47% of ulcers treated with becaplermin 100 μg/g gel completely healed, compared to 35%
which were treated with placebo gel alone. Subjects recruited into these studies were diabetic adults
aged 19 years or over who were suffering from at least one stage III or IV diabetic ulcer of at least 8
weeks duration.
5.2 Pharmacokinetic properties
Absorption
Clinical absorption studies were conducted in patients with a mean diabetic ulcer area of 10.5 cm²
(range 2.3 - 43.5 cm²). Following 14 consecutive daily topical applications of REGRANEX, there was
no consistent increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment
concentrations.
5.3 Preclinical safety data
Becaplermin was not mutagenic in a battery of
in vitro
and
in vivo
tests. Since there was no consistent
increase in plasma platelet-derived growth factor-BB concentrations above pre-treatment concentra-
tions, following 14 consecutive daily topical applications to ulcers in man, carcinogenesis and
reproductive toxicity studies have not been conducted with REGRANEX. In the process of healing the
wound, becaplermin induces cell proliferation.
In a preclinical study designed to determine the effects of PDGF on exposed bone, rats injected at the
metatarsals with 3 or 10 μg/site (concentration of 30 or 100 μg/ml/site) of becaplermin every other day
for 13 days displayed histological changes indicative of accelerated bone remodelling consisting of
periosteal hyperplasia and subperiosteal bone resorption and exostosis. The soft tissue adjacent to the
injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability
of PDGF to stimulate connective tissue growth.
Preclinical absorption studies through full-thickness wounds were conducted in rats with a wound area
of 1.4 - 1.6 cm². Systemic absorption of a single dose and multiple applications for 5 consecutive days
of becaplermin to those wounds was insignificant.
6.
6.1 List of excipients
carmellose sodium (E466)
sodium chloride
sodium acetate
glacial acetic acid (E260)
methyl parahydroxybenzoate (methylparaben) (E218)
propyl parahydroxybenzoate (propylparaben) (E216)
metacresol
lysine hydrochloride
water for injections
6.2 Incompatibilities
5
There are no known incompatibilities.
6.3 Shelf life
1 year.
Use within 6 weeks after first opening.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Close tightly after each use.
6.5
Nature and contents of container
15 g of gel in a multidose tube (laminated polyethylene-lined). Pack size of 1.
6.6 Special precautions for disposal
After treatment is completed, any unused gel should be discarded in accordance with local requirements.
7.
JANSSEN-CILAG INTERNATIONAL NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium
8.
EU/1/99/101/001
9.
Date of first authorisation: 29 March 1999
Date of latest renewal: 19 March 2009
6
ANNEX II
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
SUBSTANCE(S) AND MANUFACTURING
AUTHORISATION HOLDER (S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
7
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Novartis Pharmaceuticals Corporation (Novartis NPC)., 2010 Cessna Drive, Vacaville, CA 95688,
USA.
Name and address of the manufacturer(s) responsible for batch release
Janssen-Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium.
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Characteristics, section 4.2).
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented
in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the
CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reached
•
At the request of the EMEA
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER BOX/TUBE
1.
REGRANEX 0.01% gel
becaplermin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each gram of gel contains 100 μg of becaplermin
3.
LIST OF EXCIPIENTS
Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260),
methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben)
(E216), metacresol, lysine hydrochloride and water for injections.
See package leaflet for further information.
4.
Gel in a multidose tube (15 gram).
Pack size of 1.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For cutaneous use only.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
Use within 6 weeks after first opening.
Date opened:
11
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Close tightly after each use.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
After treatment is completed, any unused gel should be discarded in accordance with local
requirements.
Marketing authorisation holder:
JANSSEN-CILAG INTERNATIONAL NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium
EU/1/99/101/001
13. BATCH NUMBER
Batch.
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE (CARTON ONLY)
REGRANEX
12
B. PACKAGE LEAFLET
13
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGRANEX 0.01% Gel.
Becaplermin
Read all of this leaflet carefully before you start using this medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1.
What REGRANEX is and what it is used for
2.
Before you use REGRANEX
3.
How to use REGRANEX
4.
Possible side effects
5.
How to store REGRANEX
6.
Further information
1.
WHAT REGRANEX IS AND WHAT IT IS USED FOR
The name of your medicine is REGRANEX. It contains a substance called becaplermin. Becaplermin
is a human recombinant Platelet Derived Growth Factor (rhPDGF).
REGRANEX is used to help the growth of normal tissue in order to heal skin ulcers. It is used with
other good wound care measures to help with the healing of the ulcers.
Good wound care measures include:
•
Your doctor or healthcare professional removing dead skin/debris from the wound whenever
necessary
•
Keeping weight off your feet, perhaps by wearing special orthopaedic shoes or by other methods
•
Your doctor or healthcare professional treating any infection of the wound - treatment with
REGRANEX should be stopped if the wound becomes infected
•
Continuing to visit your doctor or healthcare professional and following your treatment plan
REGRANEX is used for skin ulcers that:
•
Are not more than 5 square centimetres (see diagram opposite) and have a good blood supply
•
Are due to complications of diabetes.
Insert diagram of size (circle measuring 2.524 cm in diameter)
By using REGRANEX, it is more likely that your skin ulcers will heal quickly and completely.
2.
BEFORE YOU USE REGRANEX
Do not use REGRANEX:
•
If you are allergic (hypersensitive) to becaplermin or to any of the other ingredients of
REGRANEX (listed in section 6 below)
•
If you have or have had cancer
•
If your ulcer is infected
•
If your ulcer is larger than 5 square centimetres (see diagram above)
•
If you are under 18 years of age.
14
Do not use this medicine if any of the above apply to you. If you are unsure, talk to your doctor or
pharmacist before using REGRANEX.
Take special care with REGRANEX
Check with your doctor or pharmacist before using this medicine if:
•
You have any severe or persistently worsening types of cancer
•
You have infections of the bone which may be seen as fever, severe pain around the bone that is
affected, swelling and redness of the joints
•
You have diseases of the arteries.
Taking other medicines
Do not apply any medicines to your ulcer while using REGRANEX, except for salt solution (saline) or
water to clean the ulcer.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines. This
includes medicines that you buy without a prescription or herbal medicines.
Pregnancy and breast-feeding
•
Do not use this medicine if you are pregnant, think you might be pregnant or planning to
become pregnant
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-
feeding.
Do not use this medicine if you are breast-feeding.
Important information about possible allergies to some of the ingredients
REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).
These may cause allergic reactions (possibly delayed).
3.
HOW TO USE REGRANEX
Always use this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are unsure.
The usual dose is one application once a day for a maximum of 20 weeks.
Before using REGRANEX
•
Wash your hands thoroughly. Do this before you apply REGRANEX
•
Your ulcer should be cleaned with salt solution or water. This is important to ensure the ulcer
heals as quickly and completely as possible, and to remove any REGRANEX gel from the
previous application.
Applying REGRANEX
•
Apply REGRANEX gel once a day using a clean cotton swab or wooden spatula. Apply a thin
layer of REGRANEX gel to the entire wound area. You can obtain wooden spatulas from your
pharmacist
•
Cover the ulcer with a moist saline (salt) gauze dressing. The dressing should be changed at
least once a day to keep the wound moist.
Further information
•
Only apply REGRANEX to the wound area. Avoid contact with any other area of the body
•
Do not touch the wound with the tip of the tube
•
Do not use air- or water-tight (occlusive) dressings on the wound. If you are unsure, check with
your doctor or pharmacist
15
•
•
Do not
apply pressure or walk on the ulcer during treatment. Follow your doctor’s advice to
relieve pressure from your ulcer.
Your doctor will monitor the progress of your treatment.
Contact your doctor immediately if you notice signs of infection of the ulcer (redness, swelling, fever,
pain, or odour). You should stop using it until the infection has cleared.
When to stop using REGRANEX
REGRANEX should
not be used continuously for more than 20 weeks
.
If there is
no sign of healing after the first ten weeks
of treatment,
contact your doctor
. Your doctor
will decide whether you should continue to use REGRANEX.
If your ulcer heals and then returns, do not use REGRANEX again without first checking with
your doctor.
If you use too much REGRANEX
If you apply too much REGRANEX, it is unlikely to do you any harm. Always try to follow the
instructions for use exactly.
If you forget to use REGRANEX
•
Apply the next dose as soon as possible. If it is almost time for the next application, forget about
the missed dose and continue as normal
•
Do not apply a double amount to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, REGRANEX can have side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Stop using REGRANEX and tell your doctor straight away if you notice or suspect the
following:
•
Excessive growth of new tissue at the wound (rare)
•
Infected skin ulcer (very common)
16
Other side effects
Common
•
Infections of the bone which may be seen as fever, severe pain, swelling and redness around the
bone that is affected
•
Redness and pain of skin
Uncommon
•
Burning sensation at the application site
Rare
•
Blisters and swelling under the skin
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE REGRANEX
Keep out of the reach and sight of children.
Do not use REGRANEX after the expiry date, which is stated on the tube and the outer carton after
EXP. The expiry date refers to the last date of that month.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Close the tube tightly after each use.
Use within 6 weeks after opening the seal of the tube. Please record the date of opening on the tube
label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What REGRANEX contains
The active substance in REGRANEX is becaplermin. Each gram of Regranex contains 100
micrograms of becaplermin.
The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic
acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate
(propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.
What REGRANEX looks like and contents of the pack
Regranex is presented as a gel and is filled in multi-dose tubes containing 15 grams.
Regranex is a clear colourless to straw-coloured gel.
Marketing Authorisation Holder
17
JANSSEN-CILAG INTERNATIONAL NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium
Manufacturer
JANSSEN PHARMACEUTICA NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
18
Belgique/België/Belgien
JANSSEN-CILAG N.V./S.A.
Tel: +32 3 280 54 11
Luxembourg/Luxemburg
JANSSEN-CILAG N.V./S.A.
Belgique/Belgien
Tel: +32 3 280 54 11
България
Представителство на Johnson & Johnson, d.o.o.
Тел.: +359 2 489 94 00
Magyarország
JANSSEN-CILAG Kft.
Tel: +36 23 513-800
Česká republika
JANSSEN-CILAG s.r.o.
Tel: +420 227 012 222
Malta
A.M.Mangion Ltd
Tel: +356 2397 6000
Danmark
JANSSEN-CILAG A/S
Tlf: +45 45 94 82 82
Nederland
JANSSEN-CILAG B.V.
Tel: +31 13 583 73 73
Deutschland
JANSSEN-CILAG GmbH
Tel: +49 2137-955-0
Norge
JANSSEN-CILAG AS
Tlf: +47 24 12 65 00
Eesti
Janssen-Cilag Polska Sp. z o.o. Eesti filiaal
Tel: +372 617 7410
Österreich
JANSSEN-CILAG Pharma GmbH.
Tel: +43 1 610 300
Ελλάδα
JANSSEN-CILAG Φαρμακευτική Α.Ε.Β.Ε.
Τηλ: +30 210 809 0000
Polska
JANSSEN–CILAG Polska Sp. z o.o.
Tel: +48 22 237 60 00
España
Laboratorios Dr. Esteve, S.A.
Tel: +34 93 446 60 00
Portugal
JANSSEN-CILAG FARMACÊUTICA, LDA
Tel: +351 21-436 88 35
France
ETHICON
Tel: +33 1 55 00 22 00
Info. Méd. Tel: +33 1 55 00 22 33
Romania
Johnson & Johnson d.o.o.
Janssen-Cilag Romania
Tel: +40 21 207 1800
Ireland
JANSSEN-CILAG Ltd.
United Kingdom
Tel: +44 1 494 567567
Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 30
Ísland
JANSSEN-CILAG AB
, c/o Vistor hf
Tel: +354 535 7000
Slovenská republika
Johnson & Johnson s.r.o.
Tel: +421 233 552 600
Italia
JANSSEN-CILAG SpA
Tel: +39022510.1
Suomi/Finland
JANSSEN-CILAG OY
Puh/Tel: +358 207 531 300
19
Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 755 214
Sverige
JANSSEN-CILAG AB
Tel: +46 8 626 50 00
Latvija
Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā
Tel: + 371 678 93561
United Kingdom
JANSSEN-CILAG Ltd.
Tel: +44 1 494 567567
Lietuva
UAB „Johnson & Johnson“
Tel: +370 5 278 68 88
This leaflet was last approved in mm/yyyy
Detailed information on this medicine is available on the European Medicines Agency (EMEA)
website: http://www.emea.europa.eu
20
Source: European Medicines Agency
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