Regranex

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
REGRANEX 0.01% gel  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

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. PHARMACEUTICAL FORM 
 
Gel.  
 
REGRANEX is a clear colourless to straw-coloured gel. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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 cm2. 
 
4.2 Posology and method of administration 
 
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. 
- Hands should be washed thoroughly before applying REGRANEX.  
- 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.  
 

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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.  
 
4.3 Contraindications 
 
- 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).  
 
4.4 Special warnings and precautions for use 
 
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 cm2, 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 cm2. 
 
REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate).  
These may cause allergic reactions (possibly delayed). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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. 
 
 
 
 
4.6 Pregnancy and lactation 
 
Pregnancy 
 
There are no adequate data from the use of becaplermin in pregnant women.  Consequently, 
REGRANEX should not be used during pregnancy. 

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Breastfeeding  
 
It is not known whether becaplermin is excreted in human milk. Therefore, REGRANEX should not be 
used during breastfeeding. 
 
4.7 Effects on ability to drive and use machines 
 
 No studies on the effects on the ability to drive and use machines have been performed.  
 
4.8 Undesirable effects 
 
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 Reactions 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 sensation1  

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. 
 
4.9 Overdose 
 
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. PHARMACOLOGICAL PROPERTIES 
 
5.1   Pharmacodynamic properties 
 
Pharmacotherapeutic group: Preparation for treatment of wounds and ulcers, ATC code: D 03 AX06 

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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 cm2, 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. PHARMACEUTICAL PARTICULARS 
 
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 
 

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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. MARKETING AUTHORISATION HOLDER 
 
JANSSEN-CILAG INTERNATIONAL NV 
Turnhoutseweg, 30 
B-2340 Beerse 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/99/101/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 29 March 1999 
Date of latest renewal: 19 March 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 

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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 

 

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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 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
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 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER BOX/TUBE  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
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. PHARMACEUTICAL FORM AND CONTENTS 
 
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: 
 

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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. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Marketing authorisation holder: 
JANSSEN-CILAG INTERNATIONAL NV 
Turnhoutseweg, 30 
B-2340 Beerse 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
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  
 
 

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B. PACKAGE LEAFLET 

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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. 
 

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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 
• Do not use this medicine if you are breast-feeding. 

 
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or 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 

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• 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)  

 

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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  
 

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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. 

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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: +39 022510.1 
 

Suomi/Finland 
JANSSEN-CILAG OY 
Puh/Tel: +358 207 531 300 
 

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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 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET