natgillin/translations-raw huggingface dataset:
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Postopek arbitraže se je pričel 27. julija 2006 s sprejemom seznama vprašanj.
Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Ugotovljene so bile pomembne razlike v zvezi z odmerkom za okužbe sečil in največjim dnevnim odmerkom za odrasle.
The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Imetnik dovoljenja za promet z zdravilom je posredoval pisno razlago 20. oktobra 2006.
In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev.1).
Poleg tega je bilo ocenjeno, da bi moral predlagatelj v povzetek glavnih značilnosti zdravila (poglavje 5.1) vključiti organizme, naštete v mejnih vrednostih in tabeli občutljivosti, ki se nanašajo na indikacije, kot je bilo določeno v navodilih za vrednotenje zdravil, indiciranih za zdravljenje bakterijskih okužb (Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections, CPMP/EWP/558/95 rev.1).
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim povzetkom glavnih značilnosti zdravila v Dodatku III.
submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
je predložilo vloge za medsebojno priznavanje dovoljenja za zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ml raztopino za infundiranje, na podlagi dovoljenja za promet, podeljenega na Nizozemskem 12. aprila 2005.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem januarja 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ciprofloxacin Hikma in z njim povezana imena ugodno, da naj podani ugovori ne preprečijo podelitve dovoljenja za promet z zdravilom ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names International Non-Proprietary Name (INN): Ciprofloxacin BACKGROUND INFORMATION Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Zdravilo Ciprofloxacin Hikma in z njim povezana imena, 2 mg/ml raztopina za infundiranje, je antibiotik, ki sodi v družino kinolonov in je in vitro učinkovit proti številnim po Gramu negativnim aerobnim bakterijam kakor tudi proti nekaterim po Gramu pozitivnim organizmom.
Januvia is taken at a dose of 100 mg once a day.
Zdravilo Januvia se jemlje v odmerku 100 mg enkrat na dan.
The European Commission granted a marketing authorisation valid throughout the European Union for Januvia on 21 March 2007.
Evropska komisija je dovoljenje za promet z zdravilom Januvia, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2007.
Other information about Januvia
Druge informacije o zdravilu Januvia
The full EPAR for Januvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Januvia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Januvia.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Januvia.
What benefit has Januvia shown during the studies?
Kakšne koristi je zdravilo Januvia izkazalo med študijami?
For more information about treatment with Januvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Januvia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Januvia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Zdravila Januvia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin ali katero koli drugo sestavino zdravila.
In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.
Pri bolnikih z delno ali močno okrnjenim delovanjem ledvic je treba odmerek zdravila Januvia zmanjšati.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Januvia.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Januvia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Če se zdravilo Januvia jemlje s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina znižati, da se zmanjša tveganje za hipoglikemijo (nizko koncentracijo sladkorja v krvi).
Januvia is a medicine that contains the active substance sitagliptin.
Januvia je zdravilo, ki vsebuje zdravilno učinkovino sitagliptin.
What is the risk associated with Januvia?
Kakšna tveganja so povezana z zdravilom Januvia?
The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Zdravilna učinkovina zdravila Januvia je sitagliptin, ki je zaviralec dipeptidil peptidaze-4 (DPP-4).
In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide.
V študijah, v katerih so zdravilo Januvia primerjali z drugimi zdravili, je bila učinkovitost dodajanja zdravila Januvia metforminu podobna kot pri dodajanju glipizida.
Januvia was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Zdravilo Januvia je bilo raziskano v devetih glavnih študijah, ki so vključevale skoraj 6 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ravni glukoze v krvi niso bile zadostno nadzorovane:
• two studies compared Januvia with other antidiabetes medicines.
• v dveh študijah so zdravilo Januvia primerjali z drugimi zdravili proti sladkorni bolezni.
Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Zdravilo Januvia je bilo učinkovitejše od placeba, ko so ga bolniki jemali kot samostojno zdravilo ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
The CHMP decided that Januvia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Januvia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Why has Januvia been approved?
Zakaj je bilo zdravilo Januvia odobreno?
Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Med resnimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Januvia so pankreatitis (vnetje trebušne slinavke) in preobčutljivostne (alergijske) reakcije.
In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Pri bolnikih, ki so jemali samo zdravilo Januvia so se ravni HbA1c zmanjšale za približno 8 % na začetku študij, za 0,48 % po 18 tednih in za 0,61 % po 24 tednih.
Januvia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Zdravilo Januvia se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnjo glukoze (sladkorja) v krvi.
• three additional studies compared Januvia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
• v treh dodatnih študijah so zdravilo Januvia primerjali s placebom, obe zdravili so dodajali drugim zdravilom proti sladkorni bolezni; glimepiridu (drugi vrsti sulfonilsečnine), z metforminom ali brez njega, pri 441 bolnikih ali kombinaciji metformina in rosiglitazona (agonista PPAR-gama) pri 278 bolnikih ali ustaljenemu odmerku insulina, z metforminom ali brez njega, pri 641 bolnikih.
For the full list of all side effects reported with Januvia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Januvia, glejte navodilo za uporabo.
When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.
Ob samostojnem jemanju zdravila Januvia ali metformina so bila znižanja ravni HbA1c podobna, vendar je bilo zdravilo Januvia malenkost slabše učinkovito kot metformin.
The other study compared Januvia with metformin, used on their own, in 1,058 patients;
V drugi študiji so zdravilo Januvia primerjali z metforminom pri 1 058 bolnikih, ki so obe zdravili jemali samostojno;
• in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPARgamma agonist used on its own;
• v kombinaciji z metforminom ali agonistom PPAR-gama (vrsto zdravila proti sladkorni bolezni), kot je tiazolidinedion, pri bolnikih, katerih bolezen samo z metforminom ali agonistom PPAR-gama ni zadovoljivo nadzorovana;
What is Januvia used for?
Za kaj se zdravilo Januvia uporablja?
Januvia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
• v štirih študijah so zdravilo Januvia primerjali s placebom (zdravilom brez zdravilne učinkovine): zdravilo Januvia ali placebo so bolniki jemali samostojno v dveh študijah, ki sta vključevali 1 262 bolnikov, kot dodatek metforminu v eni študiji s 701 bolnikom in kot dodatek pioglitazonu (agonistu PPAR-gama) v eni študiji s 353 bolniki;
HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Ravni HbA1c so bile po 18 tednih znižane za 1,03 % pri bolnikih, ki so zdravilo Januvia dodajali metforminu in rosiglitazonu, v primerjavi z znižanjem za 0,31 % pri tistih, ki so kot dodatek prejemali placebo.
How has Januvia been studied?
Kako je bilo zdravilo Januvia raziskano?
Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Ravni so se znižale za 0,59 % pri bolnikih, ki so zdravilo Januvia dodajali insulinu (z metforminom ali brez njega) v primerjavi z zmanjšanjem za 0,03 % pri tistih, ki so kot dodatek jemali placebo.
In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
V dodatnih študijah je dodajanje zdravila Januvia glimepiridu (z metforminom ali brez njega) po 24 tednih znižalo ravni HbA1c za 0,45 % v primerjavi s povečanjem za 0,28 % pri bolnikih, pri katerih so dodajali placebo.
How does Januvia work?
Kako zdravilo Januvia deluje?
What is Januvia?
Kaj je zdravilo Januvia?
How is Januvia used?
Kako se zdravilo Januvia uporablja?
One study compared Januvia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
V eni študiji so pri 1 172 bolnikih primerjali zdravilo Januvia z glipizidom (sulfonilsečnino), obe zdravili pa so dodajali metforminu.
When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Če je bilo zdravilo Januvia dodano pioglitazonu, je po 24 tednih znižalo ravni HbA1c za 0,85 % v primerjavi z znižanjem za 0,15 % pri bolnikih, ki so kot dodatek jemali placebo.
Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Če je bilo zdravilo Januvia dodano metforminu, je po 24 tednih znižalo ravni HbA1c za 0,67 % v primerjavi z znižanjem za 0,02 % pri bolnikih, ki so kot dodatek jemali placebo.
0.12% and 0.18%, respectively, in the patients taking placebo.
Pri bolnikih, ki so jemali placebo, pa so se povečale za 0,12 % oziroma 0,18 %.
Two of these studies included children.
Dve od teh študij sta vključevali otroke.
Opatanol has been studied in 688 patients in four main studies lasting between six and 14 weeks.
Zdravilo Opatanol so raziskali pri 688 bolnikih v štirih glavnih študijah, ki so trajale od 6 do 14 tednov.
The European Commission granted a marketing authorisation valid throughout the European Union for Opatanol on 17 May 2002.
Evropska komisija je dovoljenje za promet z zdravilom Opatanol, veljavno po vsej Evropski uniji, izdala 17. maja 2002.
Opatanol can be used for up to four months, if needed.
Zdravilo Opatanol se lahko po potrebi uporablja največ štiri mesece.
Opatanol is used in adults and children aged three years and older.
Zdravilo Opatanol se uporablja pri odraslih in otrocih, starejših od treh let.
The full EPAR for Opatanol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Opatanol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicine s/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Opatanol.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Opatanol.
These include itching, redness and swelling.
Ti simptomi vključujejo srbenje, pordelost in otekanje.
For more information about treatment with Opatanol, read the package leaflet (also part of the EPAR) or contact your doctor of pharmacist.
Za več informacij o zdravljenju z zdravilom Opatanol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Opatanol (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, dry eyes, abnormal sensations in the eye, dry nose and fatigue (tiredness).
Najpogostejši neželeni učinki pri uporabi zdravila Opatanol (opaženi pri 1 do 10 bolnikih od 100) so glavobol, disgevzija (motnje okušanja), bolečine v očeh, draženje očesa, nenormalni občutki v očesu, suha sluznica v nosu in utrujenost.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Opatanol.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Opatanol, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
If another eye treatment is also being used, there should be a gap of five minutes between treatments; eye ointments should be administered last.
Če se istočasno izvaja še kako drugo zdravljenje očesa, je treba zdravila dajati z razmikom petih minut, pri čemer mazila za oči nanašamo nazadnje.
Opatanol was as effective as cromolyn sodium and as levocabastine.
Zdravilo Opatanol je bilo enako učinkovito kot natrijev kromoglikat in levokabastin.
The CHMP decided that Opatanol's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Opatanol večje od z njim povezanih tveganj pri zdravljenju očesnih znakov in simptomov sezonskega alergijskega konjunktivitisa, in priporočil, da se zanj izda dovoljenje za promet.
What benefit has Opatanol shown during the studies?
Kakšne koristi je zdravilo Opatanol izkazalo med raziskavami?
At lower pollen counts, there were no differences between the two treatments.
Pri nizkih koncentracijah cvetnega prahu razlik med obema zdraviloma ni bilo.
What is the risk associated with Opatanol?
Kakšna tveganja so povezana z zdravilom Opatanol?
Other information about Opatanol
Druge informacije o zdravilu Opatanol:
Therefore care should be taken by people who wear soft contact lenses.
Zato morajo biti osebe z mehkimi kontaktnimi lečami pri uporabi previdne.
Opatanol contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo Opatanol vsebuje benzalkonijev klorid, katerega znana lastnost je, da razbarva mehke kontaktne leče.
Opatanol was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment).
Zdravilo Opatanol so primerjali z natrijevim kromoglikatom (drugo vrsto zdravila proti alergijam), z levokabastinom (drugo vrsto antihistaminskega zdravila), v dveh študijah pa so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
When compared with placebo, Opatanol was more effective only when pollen counts were taken into account, showing that the higher the level of pollen in the air, the greater the difference between the effects of Opatanol and those of placebo.
V primerjavi s placebom je bolj učinkovito le, če se upošteva tudi količina cvetnega prahu, pri čemer se je pokazalo, da je bila razlika med učinki zdravila Opatanol in placeba tem večja, čim večja je bila koncentracija cvetnega prahu v zraku.
For the full list of all side effects reported with Opatanol, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Opatanol, glejte navodilo za uporabo.
Opatanol is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Zdravilo Opatanol se uporablja za zdravljenje očesnih simptomov sezonskega alergijskega konjunktivitisa (vnetja oči, ki ga pri bolnikih s senenim nahodom povzroča cvetni prah).
Why has Opatanol been approved?
Zakaj je bilo zdravilo Opatanol odobreno?
It is given as one drop into the affected eye(s) twice a day, given eight hours apart.
Odmerek zdravila Opatanol je ena kapljica v prizadeto oko (očesi) dvakrat na dan v osemurnih presledkih.
Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Olopatadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske
The active substance in Opatanol, olopatadine, is an antihistamine.
Zdravilna učinkovina zdravila Opatanol je olopatadin, ki je antihistaminsko zdravilo.
How has Opatanol been studied?
Kako je bilo zdravilo Opatanol raziskano?
What is Opatanol used for?
Za kaj se zdravilo Opatanol uporablja?
What is Opatanol?
Kaj je zdravilo Opatanol?
Opatanol is a clear eye drop solution, which contains the active substance olopatadine.
Zdravilo Opatanol so kapljice za oko v obliki bistre raztopine, ki vsebuje zdravilno učinkovino olopatadin.
How does Opatanol work?
Kako zdravilo Opatanol deluje?
In all of the studies, the main measure of effectiveness was based on the degree of itching and redness in the eye. One of the placebo studies also looked at these symptoms in relation to pollen counts.
V vseh študijah je glavno merilo učinkovitosti temeljilo na intenzivnosti srbenja in pordelosti očesa.
How is Opatanol used?
Kako se zdravilo Opatanol uporablja?
183 11 Täby Sweden
183 11 Täby Švedska
2710-444 Sintra Portugal
2710-444 Sintra Portugalska
0667 Oslo Norway
0667 Oslo Norveška
Lumiracoxib 100 mg tablets
Lumiracoxib 100 mg tablete
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
U Nákladového nádraží 10 130 00 Praha 3
U Nákladového nádraží 10 130 00 Praga 3
Strength Pharmaceutical form Route of administration
Farmacevtska oblika Pot uporabe
Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Hungary
Novartis Hungária Kft. 1114 Budapest Bartók Béla út 43-47 Madžarska
Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Denmark
Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 København Ø Danska
6824 DP Arnhem Nederland
6824 DP Arnhem
Novartis Pharmaceuticals UK Limited,
Velika Britanija Novartis Pharmaceuticals UK Limited,
Novartis Pharmaceuticals UK Limited
Velika Britanija Novartis Pharmaceuticals UK Limited
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR UK
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU-167-SR Velika Britanija
Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey UK
Novartis Pharmaceuticals UK Ltd. Frimley Business Park, Frimley, Camberly, GU16 7SR Surrey Velika Britanija
Nederlands
Nizozemska
Novartis Pharma GmbH Brunner Straße 59 1235 Wien
Novartis Pharma GmbH Brunner Straße 59 1235 Dunaj
Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Finland
Novartis Finland Oy, Metsänneidonkuja 10, FI-02130, Espoo Finska
Belgium Novartis Pharma NV Medialaan 40 bus 1
Novartis Pharma NV Medialaan 40 bus 1 B-1800 Vilvoorde Belgija
Member State Marketing Authorisation Holder (Invented) name
Država članica Imetnik dovoljenja za promet z zdravilom
Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130 Espoo Finland
Novartis Finland Oy, Metsanneidonkuja-10, FIN-02130 Espoo Litva
U Nákladového nádraží 10 130 00 Prague 3
Novartis s.r.o., Nagano III. U Nákladového nádraží 10 130 00 Praga 3
90429 Nürnberg Germany
90429 Nürnberg Nemčija
D-90429 Nuernberg Germany
D-90429 Nuernberg Nemčija
Novartis Pharma B.V. Raapopseweg 1
Nizozemska Novartis Pharma B.V.
Frimley Business Park Frimley, Camberley Surrey GU16 7SR UK
Surrey GU16 7SR
D-90429 Nurnberg Germany
D-90429 Nürnberg Nemčija
{Name and address} {tel} {fax} {e-mail}
{Ime in naslov} {tel.} {faks} {e-pošta}
An effect in man cannot be excluded.
Vpliva pri človeku ni mogoče izključiti.
Number (%) of patients who had died.
Število (%) umrlih bolnic.
It is a long-term treatment and you may need to take it for several years.
To je dolgotrajno zdravljenje in morda boste zdravilo morali jemati več let.
Your tablets could harm them.
Te tablete jim lahko škodujejo.