Lucentis 10 mg/ml solucion inyectable
Introduction
Prospecto:information for adult patient
LUCENTIS 10mg/ml injectable solution
ranibizumab
ADULTS
Information for premature babies on the other side of the prospectus.
Read this prospectus carefully beforeyou are administered this medication, because it contains important information for you.
-Keep this prospectus, as you may need to read it again.
-If you have any doubts, consult your doctor.
-Ifyou experienceadverse effects, consult your doctor,evenifthey are not listed in this prospectus. See section4.
1.What is LUCENTIS and for what it is used
2.What you need to knowbefore you are administered LUCENTIS
3.How LUCENTIS is administered
4.Possible adverse effects
5.Storage of LUCENTIS
6.Contents of the package and additional information
1. What is Lucentis and what is it used for
What is Lucentis
Luentis is a solution that is injected into the eye. Lucentis belongs to a group of medications called anti-neovascular agents. It contains the active ingredient called ranibizumab.
What is Lucentis used for
Luentis is used in adults to treat several eye diseases that cause vision impairment.
These diseases are the result of a retinal injury (the light-sensitive layer at the back of the eye) caused by:
-The growth of abnormal blood vessels that leak fluid. This is seen in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularization (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
-Macular edema (swelling of the center of the retina). The cause of this swelling can be diabetes (a disease known as diabetic macular edema (DME)) or a blockage of the retinal veins in the retina (a disease known as retinal vein occlusion (RVO)).
How Lucentis works
Luentis recognizes and specifically binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eyes. In excess, VEGF-A causes the growth of abnormal blood vessels and swelling in the eye that can cause vision impairment in diseases such as AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Lucentis can prevent it from acting and prevent said abnormal growth and swelling.
In these diseases, Lucentis can help stabilize and, in many cases, improve vision.
2. What you need to know before they give you Lucentis
Do not administer Lucentis
-If you are allergic to ranibizumab or any of the other components of this medication (listed in section 6).
-If you have an infection in the eye or around it.
-If you have severe eye pain or redness (intraocular inflammation).
Warnings and precautions
Consult your doctor before receiving Lucentis
-Luentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, an infection in the inner part of the eye, eye pain, or redness (inflammation), retinal detachment or tear, or clouding of the lens (cataract) may occur. It is essential to identify and treat such an infection or retinal detachment as soon as possible. Inform your doctor immediately if you notice signs such as eye pain or increased eye discomfort, worsening eye redness, blurry vision or decreased vision, an increase in small spots in your vision, or increased sensitivity to light.
-In some patients, eye pressure may increase temporarily after the injection. Your doctor may monitor your eye pressure after each injection, as you may not be aware of it.
-Inform your doctor if you have had eye diseases or received eye treatment previously, or if you have had a stroke or had transient signs of a stroke (weakness or paralysis of a limb or face, difficulty speaking or understanding). This information will be taken into consideration to evaluate whether Lucentis is the appropriate treatment for you.
For more detailed information on possible side effects that may occur during treatment with Lucentis, see section 4 (“Possible side effects”).
Children and adolescents (under 18 years)
Except for retinopathy of prematurity, the use of Lucentis is not recommended in children and adolescents, as it has not been established in these age groups. For the treatment of premature babies with retinopathy of prematurity (ROP), see the other side of the prospectus.
Other medications and Lucentis
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
-Women who may become pregnant should use an effective contraceptive method during treatment and for at least three months after the last Lucentis injection.
-There is no experience with the use of Lucentis in pregnant women. Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before treatment with Lucentis.
-Small amounts of Lucentis may pass into breast milk, so the use of Lucentis is not recommended during breastfeeding. Consult your doctor or pharmacist before treatment with Lucentis.
Driving and operating machinery
After treatment with Lucentis, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until this symptom disappears.
3. How Lucentis is administered
Lucentis is administered by the ophthalmologist as a single injection in the eye under local anesthesia.The usual dose of a single injection is 0.05ml (which contains 0.5mg of active ingredient). The interval between two doses applied in the same eye must be at least four weeks. All injections will be administered by an ophthalmologist.
To prevent an infection, before the injection, your doctor will carefully wash your eye. Your doctor will also administer a local anesthetic to reduce or prevent any pain you may feel with the injection.
Treatment begins with a Lucentis injection every month. Your doctor will monitor your eye disease and, depending on how you respond to treatment, will decide if you need or do not need further treatment and when you need to be treated.
At the end of the prospectus in the section "How to prepare and administer Lucentis in adults" detailed use instructions are given.
Patients aged 65years and older)
Lucentis can be used in people 65years of age or older, and no dose adjustment is necessary.
Before interrupting treatment with Lucentis
If you are considering interrupting treatment with Lucentis, attend the next consultation and discuss it with your doctor beforehand. Your doctor will advise you and decide for how long you should be treated with Lucentis.
If you have any other questions about the use of this medication, ask your doctor.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects associated with the administration of Lucentis are due either to the medicine itself or to the injection procedure, and most affect the eye.
Below are described the most serious side effects:
Common serious side effects(may affect up to 1 in 10patients): Detachment or tear of a layer in the inner part of the eye (retinal detachment), which results inflashes of light with floating particles that progress to transient vision loss or to a clouding of the lens (cataract).
Rare serious side effects(may affect up to 1 in 100patients):Blindness, endophthalmitis (infection of the globe of the eye) with inflammation of the inner part of the eye.
The symptoms you may experience are eye pain or increased discomfort in the eye, if the redness in the eye worsens, blurred vision or decreased vision, an increase in the number of small spots in the vision or increased sensitivity to light.Inform your doctor immediately if you experience any of these side effects.
Below are described the most frequently reported side effects:
Very common side effects(may affect more than 1 in 10patients)
The ocular side effects include: Inflammation of the eye, bleeding in the back of the eye (retinal hemorrhage), visual disturbances, eye pain, small particles or spots in the vision (floaters), blood in the eye, eye irritation, sensation of having something in the eye, increased tear production, inflammation or infection in the eyelid margin, dry eye, redness or itching in the eye, and increased eye pressure.
The non-ocular side effects include: Sore throat, nasal congestion, nasal discharge, headache, and joint pain.
Below are described other side effects that may occur after treatment with Lucentis:
Common side effects
Theocular side effects include: Decreased visual acuity, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of the eye),small marks on the surface of the eye, blurred vision, bleeding at the injection site,bleeding in the eye, eye discharge with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, eyelid swelling, and eyelid pain.
Thenon-ocular side effects include: Urinary tract infection, low red blood cell count (with symptoms such as fatigue, difficulty breathing, dizziness, pallor), anxiety, cough,nausea, allergic reactions such as rash, urticaria, itching, and skin redness.
Rare side effects
Theocular side effects include: Inflammation and bleeding in the front part of the eye, accumulation of pus in the eye, changes in the central part of the ocular surface, pain or irritation at the injection site, abnormal sensation in the eye, eyelid irritation.
Reporting of side effects
If you experience any type of side effect, consultyour doctor,even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Lucentis
-Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the box after CAD and on the vial label after EXP. The expiration date is the last day of the month indicated.
-Store in refrigerator (between 2°C and 8°C). Do not freeze.
-Before use, the unopened vial can be stored at room temperature (25°C) for a maximum of 24hours.
-Store the vial in the outer packaging to protect it from light.
-Do not use any damaged packaging.
6. Contents of the packaging and additional information
Composition of Lucentis
-The active ingredient is ranibizumab. Each ml contains 10 mg of ranibizumab.Cada vial contains 2.3 mg of ranibizumab in 0.23 ml of solution. This provides an adequate amount to provide a single dose of 0.05 ml, which contains 0.5 mg of ranibizumab.
-The other components are α, α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polisorbate 20; water for injections.
Aspect of the product and contents of the package
Lucentis is an injectable solution contained in a vial (0.23 ml). The solution is transparent, colorless to pale yellowish brown and aqueous.
Two types of packaging are available:
Package with vial only
Package containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper. The vial is for single use.
Package with vial + needle with filter
Package containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper and a blunt needle with filter (18G x 1½″, 1.2 mm x 40 mm, 5 micrometers) for extracting the contents of the vial. All components are for single use.
Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Responsible for manufacturing
Novartis Pharmaceutical, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 | Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 |
Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 | |
Ceská republika Novartis s.r.o. Tel: +420 225 775 111 | Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00 |
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 | Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 | Norge Novartis Norge AS Tlf: +47 23 05 20 00 |
Ελλ?δα Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12 | Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 |
España Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00 | Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888 |
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00 | Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600 |
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 |
Κ?προς Novartis Pharma Services Inc. Τηλ: +357 22 690 690 | Sverige Novartis Sverige AB Tel: +46 8 732 32 00 |
Latvija SIA Novartis Baltics Tel: +371 67 887 070 |
Last update of this leaflet:
Other sources of information
The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu
This information is intended solely for healthcare professionals:
See also section 3 “How to administer Lucentis”.
How to prepare and administer Lucentis in adults
Vial for single use. Only for intravitreal use.
Lucentis should be administered by an ophthalmologist experienced in the administration of intravitreal injections.
In the exudative age-related macular degeneration, in the neovascular glaucoma, in the retinal detachment and in the visual alteration due to EMD or to secondary macular edema to OVR the recommended dose of Lucentis is 0.5 mg administered as a single intravitreal injection. This corresponds to a volume of injection of 0.05 ml. The interval between two injected doses in the same eye should be at least four weeks.
The treatment starts with a monthly injection until the maximum visual acuity is reached and/or there are no signs of disease activity, i.e. no change in visual acuity or in other signs and symptoms of the disease under continued treatment.In patients with exudative age-related macular degeneration, EMD, retinal detachment and OVR initially three or more consecutive injections may be required, administered monthly.
From then on, the monitoring and treatment intervals should be determined according to medical judgment and based on the disease activity, evaluated by visual acuity and/or anatomical parameters.
The treatment with Lucentis should be discontinued if, under medical judgment, the visual and anatomical parameters indicate that the patient is not benefiting from continued treatment.
The monitoring to determine the disease activity may include clinical examination, functional control or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
If patients are being treated according to a treat and extend regimen, once the maximum visual acuity has been reached and/or there are no signs of disease activity, the treatment intervals can be gradually spaced until signs of disease activity or visual alteration reappear. In the case of exudative age-related macular degeneration, the treatment interval should not be spaced more than two weeks at a time, and in the case of EMD it can be spaced up to one month at a time. For retinal detachment and OVR, the treatment intervals can also be gradually spaced, however the data available are not sufficient to determine the duration of these intervals. If disease activity reappears, the treatment interval should be shortened accordingly.
The treatment of visual alteration due to neovascular glaucoma should be determined on an individual basis for each patient, based on the disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. In the case of neovascular glaucoma secondary to pathological myopia (MP), many patients may only need one or two injections during the first year.
Lucentis and laser photocoagulation in EMD and secondary macular edema to branch vein occlusion (ORVR)
There is some experience with Lucentis administered concomitantly with laser photocoagulation. When administered on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have previously received laser photocoagulation.
Lucentis and verteporfin photodynamic therapy in neovascular glaucoma secondary to MP
There is no experience with the concomitant administration of Lucentis and verteporfin.
Before administering Lucentis, the absence of particles and discoloration should be visually checked.
The injection procedure should be carried out under aseptic conditions, including surgical hand washing, the use of sterile gloves, a sterile field, a sterile eyelid speculum (or equivalent) and the availability of a sterile paracentesis (if necessary). Before performing the intravitreal injection procedure, the patient's medical history should be thoroughly evaluated for hypersensitivity reactions. Before the injection, an adequate anesthesia and a broad-spectrum topical antimicrobial should be administered to disinfect the skin of the periocular area, eyelid and ocular surface, in accordance with local practice.
Package with vial only
The vial is for single use. After the injection, any unused product should be discarded. Any vial showing signs of deterioration or manipulation should not be used. Sterility can only be guaranteed if the packaging seal remains intact.
The following medical devices are required for the preparation and intravitreal injection of Lucentis in adults:
-a 5 µm filter needle (18G); not included in the Lucentis package
-a sterile 1 ml syringe (including a 0.05 ml mark); not included in the Lucentis package
-a 30G x ½″ injection needle.
These medical devices are not included in the Lucentis package.
Package with vial + needle with filter
All components are sterile and for single use. Any component whose packaging shows signs of deterioration or manipulation should not be used. Sterility can only be guaranteed if the packaging seal of the components remains intact. Reuse may lead to infection or other disease/lesion.
The following medical devices are required for the preparation and intravitreal injection of Lucentis in adults:
-a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometers); supplied
-a sterile 1 ml syringe (including a 0.05 ml mark); not included in the Lucentis package
-a 30G x ½″ injection needle; not included in the Lucentis package
For the preparation and intravitreal injection of Lucentis in adults, follow the instructions for use provided with the Lucentis package.
The injection needle should be inserted 3.5-4.0 mm behind the limbus in the vitreous cavity, avoiding the horizontal meridian and in the direction of the optic nerve. Subsequently, the volume of injection of 0.05 ml should be released; subsequent injections should be applied each time in a different scleral point.
After the injection, the needle should not be capped with the stopper or separated from the syringe. The used syringe and needle should be disposed of in a sharps container or according to local regulations.
Leaflet for healthcare professionals:
Information for baby's caregivers
LUCENTIS 10 mg/ml solution for injection
ranibizumab
BABIES BORN PRETERM
Information for adults on the other side of the leaflet.
Please read this leaflet carefully before administering this medicine to your baby, because it contains important information for you.
-Keep this leaflet, as you may need to read it again.
-If you have any doubts, consult your baby's doctor.
-If your baby experiences any side effects, consult your baby's doctor, even if they are side effects that do not appear in this leaflet. See section 4.
1.What is Lucentis and what is it used for
What is Lucentis
Lucentis is a solution that is injected into the eye. Lucentis belongs to a group of medicines called anti-vascular endothelial growth factor (VEGF) agents. It contains the active ingredient ranibizumab.
What is Lucentis used for
Lucentis is used in babies born preterm to treat retinopathy of prematurity (ROP), a disease that causes visual impairment due to abnormal growth of blood vessels in the eye.
How Lucentis works
Lucentis recognizes and binds specifically to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes the abnormal growth of blood vessels in the eye. Lucentis can prevent this and prevent abnormal growth.
2.What you need to know before Lucentis is administered to your baby
Do not administer Lucentis to your baby
-If your baby is allergic to ranibizumab or to any of the other components of this medicine (including those listed in section 6).
-If your baby has an eye infection or around the eye.
-If your baby has severe eye inflammation (intraocular inflammation).
Warnings and precautions
Consult your baby's doctor before administering Lucentis to your baby
-Lucentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, an eye infection, eye inflammation, retinal detachment or retinal pigment epithelium detachment, or cataract may occur. It is essential to identify and treat such an infection or retinal detachment as soon as possible. Inform your baby's doctor immediately if your baby experiences eye pain or if eye inflammation worsens.
In some patients, after the injection, the eye pressure may increase for a short period of time. Your baby's doctor may monitor the eye pressure after each injection.
For more detailed information on possible side effects that may occur during treatment with Lucentis, see section 4 (Possible side effects).
Other medicines and Lucentis
Inform your baby's doctor if your baby is taking, has taken recently or may need to take any other medicine.
3.How to administer Lucentis
Lucentis is administered by the ophthalmologist as a single injection into the eyes of your baby, usually under local anesthesia.The usual dose of a single injection is 0.02 ml (which contains 0.2 mg of active ingredient). The interval between two doses injected in the same eye should be at least four weeks.All injections will be administered by the ophthalmologist.
The treatment starts with a single injection of Lucentis in each eye (some babies may need treatment in only one eye). The ophthalmologist will monitor the disease in your baby's eyes and, depending on how your baby responds to treatment, decide whether your baby needs or does not need further treatment and when your baby needs to be treated.
At the end of the leaflet, in the section “How to prepare and administer Lucentis in preterm babies”, detailed instructions for use are provided.
Before interrupting treatment with Lucentis
If you are considering interrupting treatment with Lucentis in your baby, attend the next consultation and discuss it with your baby's doctor beforehand. Your baby's doctor will advise and decide for how long your baby should be treated with Lucentis.
If you have any other doubts about the use of this medicine, ask your baby's doctor.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects associated with the administration of Lucentis are either due to the medicine itself or the injection procedure, and most of them affect the eye.
Following are the most frequent side effects in preterm babies:
The eye-related side effects include: retinal hemorrhage, eye bleeding or bleeding at the injection site, and eye bleeding (conjunctival hemorrhage).
The non-eye-related side effects include: sore throat, nasal congestion and nasal discharge, low red blood cell count (with symptoms such as fatigue, difficulty breathing, and pale skin), cough, urinary tract infection, allergic reactions such as rash and skin redness.
Following are additional side effects, which have been observed with Lucentis in adults. These side effects may also occur in preterm babies:
Following are the most severe side effects in adults:
Severe side effects that may occur in up to 1 in 10 patients: retinal detachment that progresses to transient vision loss or cataract.
Severe side effects that may occur in up to 1 in 100 patients: blindness, endophthalmitis (infection of the eye globe) with intraocular inflammation.
It is essential to identify and treat severe side effects, such as endophthalmitis or retinal detachment, as soon as possible. Inform your baby's doctor immediately if your baby experiences eye pain or if eye inflammation worsens.
Following are the most frequent side effects in adults:
Very common side effects (may affect more than 1 in 10 patients): eye inflammation, visual disturbances, eye pain, small particles or spots in vision (floaters), eye irritation, sensation of something in the eye, increased tear production, inflammation or infection of the eyelid margin, dry eye, eye redness or itching, and increased eye pressure.
Common side effects:
The eye-related side effects include: decreased visual acuity, corneal edema, corneal inflammation (corneal ulcer), small marks on the eye surface, blurred vision, eye discharge with itching, eye redness or swelling (conjunctivitis), light sensitivity, eye discomfort, eyelid swelling, and eye pain.
The non-eye-related side effects include: anxiety, nausea.
Reporting of side effects
If your baby experiences any side effects, consult your baby's doctor, even if they are side effects that do not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5.Storage of Lucentis
-Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date that appears on the box after CAD and on the vial label after EXP. The expiry date is the last day of the month indicated.
-Store in the refrigerator (between 2°C and 8°C). Do not freeze.
-Before use, the unopened vial can be stored at room temperature (25°C) for a maximum of 24 hours.
-Store the vial in the outer packaging to protect it from light.
-Do not use any packaging that is damaged.
6.Contents of the package and additional information
Composition of Lucentis
-The active ingredient is ranibizumab. Each ml contains 10 mg of ranibizumab.Cada vial contains 2.3 mg of ranibizumab in 0.23 ml of solution. This provides an adequate amount to provide a single dose of 0.02 ml, which contains 0.2 mg of ranibizumab.
-The other components are α, α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polisorbate 20; water for injections.
Aspect of the product and contents of the package
Lucentis is an injectable solution contained in a vial (0.23 ml). The solution is transparent, colorless to pale yellowish brown and aqueous.
Two types of packaging are available:
Package with vial only
Package containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper. The vial is for single use.
Package with vial + needle with filter
Package containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper and a blunt needle with filter (18G x 1½″, 1.2 mm x 40 mm, 5 micrometers) for extracting the contents of the vial. All components are for single use.
Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Responsible for manufacturing
Novartis Pharmaceutical, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 | Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 |
Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11 | |
Ceská republika Novartis s.r.o. Tel: +420 225 775 111 | Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00 |
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 | Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 | Norge Novartis Norge AS Tlf: +47 23 05 20 00 |
Ελλ?δα Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12 | Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 |
España Novartis Farmacéutica, Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. |
