natgillin/translations-raw huggingface dataset:
What {PRODUCT NAME} 80 mg looks like and contents of the pack {PRODUCT NAME} film-coated tablets are white with an oval shape.
Izgled zdravila {(Lastniško) ime} 80 mg in vsebina pakiranja
They are marked with 80 on one side and PD158 on the other side.
{(Lastniško) ime} 80 mg filmsko obložene tablete so bele in ovalne oblike.
107
99
22 May 2006 CHMP/ 477258/ 2006
22. maj 2006 CHMP/ 477258/ 2006
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 6( 12)
Sortis and associated names contain atorvastatin, a HMG-CoA-reductase inhibitor (known as statin), which inhibits the synthesis of cholesterol.
Sortis in z njim povezana imena vsebujejo atorvastatin, zaviralec HMG- CoA reduktaze (znan pod imenom statin), ki zavira sintezo holesterola.
Atorvastatin is currently indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Atorvastatin je trenutno indiciran kot dopolnilo k prehrani za zniževanje zvišanega skupnega holesterola, holesterola- LDL, apolipoproteina B in trigliceridov pri bolnikih s primarno hiperholesterolemijo vključno z družinsko hiperholesterolemijo (heterozigotna različica) ali kombinirano (mešano) hiperlipidemijo (ki ustreza tipoma IIa in IIb po Fredricksonovi klasifikaciji), kadar je odziv na dieto in druge nefarmakološke ukrepe nezadosten.
Atorvastatin is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e. g.
Atorvastatin je indiciran tudi za zniževanje skupnega holesterola (total- C), holesterola LDL (LDL- C) pri bolnikih s homozigotno družinsko hiperholesterolemijo kot dopolnilo drugim terapijam za zniževanje lipidov (npr.
LDL apheresis) or if such treatments are unavailable.
LDL – afereza), ali kadar take terapije niso na voljo.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the “ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors”.
Ta napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi s spremembo tipa II za novo indikacijo in sicer “ preprečevanje kardiovaskularnih dogodkov pri bolnikih z ocenjenim visokim tveganjem za prvi kardiovaskularni dogodek, kot dopolnilo pri odpravljanju drugih dejavnikov tveganja. ”.
At the end of the MRP procedure there was a discrepancy between different Member States regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/ 2003, as amended, was notified by Spain to the CHMP on 1.12.2005.
1084/ 2003, kot je bila spremenjena, je Španija obvestila CHMP dne 1. decembra 2005.
The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in December 2005, and a Rapporteur (Dr Eric Abadie) and Co-Rapporteur (Dr Bengt Ljungberg) were appointed.
Bengt Ljungberg).
The questions identified pertained to: i) the lack of a significant effect in favour of atorvastatin for the composite primary endpoint and several secondary endpoints in the female subgroup, ii) the exclusion of non-diabetic patients at high cardiovascular risk from the proposed indication, iii) the higher cardioprotective effect of atorvastatin when used in combination with particular antihipertensive therapies iv) the extent to which the claimed therapeutic indication could be applied to atorvastatin doses other than those tested in the pivotal trials
Ugotovljena vprašanja so se nanašala na: i) odsotnost značilno pomembnega učinka v prid atorvastatinu za kombinirano primarno končno točko in za več sekundarnih končnih točk v ženski podskupini, ii) izključitev nediabetičnih bolnikov z visokim kardiovaskularnim tveganjem iz predlagane indikacije, iii) večji kardiozaščitni učinek atorvastatina, kadar je v kombinaciji z določenimi antihipertenzivnimi terapijami iv) obseg, do katerega je lahko zahtevana terapevtska indikacija veljavna tudi za odmerke atorvastatina, ki niso bili preizkušeni v osrednji raziskavi.
Based on the evaluation of the currently available data and the (Co-)Rapporteurs’ assessment reports, the CHMP adopted an opinion on 23 March 2006 recommending the variation of the Marketing Authorisations for the addition of the following new indication: “ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors .”
Na podlagi ovrednotenja trenutno razpoložljivih podatkov in poročil o oceni, ki sta jih podala poročevalec in soporočevalec, je CHMP dne 23. marca sprejel mnenje s katerim je priporočil dopolnitev dovoljenj za promet z zdravilom tako, da se doda naslednja indikacija: “ Preprečevanje kardiovaskularnih dogodkov pri bolnikih z ocenjenim visokim tveganjem za prvi kardiovaskularni dogodek, kot dopolnilo pri odpravljanju drugih dejavnikov tveganja. ”
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu The list of product names concerned is given in the Annex I.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu Seznam zadevnih imen zdravil je naveden v Dodatku I.
The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III.
Znanstveni zaključki so podani v Dodatku II, skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
* Notes:
* Opombe:
The information given in this document and Annexes reflect only the CHMP Opinion dated 23 March 2006.
Informacije, podane v tem dokumentu in v Dodatkih odražajo samo mnenje CHMP z dne 23. marca 2006.
Herbststraße 6-10 1160 Wien Austria
Herbststraße 6- 10 1160 Wien Avstrija
Avenue Louise 143 B-1050 Bruxelles
Avenue Louise 143 B- 1050 Bruxelles Belgija
Sorou 18-20 151 25 Marousi Athens Greece
Sorou 18- 20 151 25 Marousi Athens Grčija
Bayer HealthCare AG 51368 Leverkusen
Bayer HealthCare AG 51368 Leverkusen Nemčija
De Zeneta, 149 30588 Murcia
De Zeneta, 149 30588 Murcia Španija
2 FI - Finland
2 FI - Finska
Bayer Hungária Kft Alkotás ut.50 1123 Budapest Hungary
Bayer Hungária Kft Alkotás ut. 50 1123 Budapest Madžarska
Bayer Limited The Atrium Blackthorn Road Dublin 18 Ireland
Bayer Limited The Atrium Blackthorn Road Dublin 18 Irska
Avenue Louise 143
Avenue Louise 143 B- 1050 Bruxelles Belgija
NL - Netherlands
NL - Nizozemska
Bayer BV Energieweg 1 3641 RT Mijdrecht Nederland
Bayer BV Energieweg 1 3641 RT Mijdrecht Nizozemska
3 PL - Poland
3 PL - Poljska
Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Rua Quinta do Pinheiro, 5 2794- 003 Carnaxide Portugalska
Bravnič arjeva 13 1000 Ljubljana Slovenija
Bravničarjeva 13 1000 Ljubljana Slovenija
UK - United Kingdom
UK – Velika Britanija
4 ANNEX II
4 DODATEK II
5 SCIENTIFIC CONCLUSIONS
5 ZNANSTVENI ZAKLJUČKI
Avalox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Avalox – filmsko obložene tablete vsebujejo 400 mg moksifloksacina v obliki klorida.
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.
Ta postopek je napotitev na podlagi postopka medsebojnega priznavanja v zvezi z zgornjo vlogo za spremembo, ki je bila za zdravilo Avalox – filmsko obložene tablete Nemčiji kot referenčni državi članici in zadevnim državam članicam AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK in UK predložena dne 5. decembra 2006.
The MRP variation application DE/ H/ 155/ 01/ II/ 38 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis.
Vloga za odobritev spremembe po postopku medsebojnega priznavanja DE/ H/ 155/ 01/ II/ 38 je zadevala razširitev indikacije, tako da bi vključevala zdravljenje blagih do zmernih pelvičnih vnetnih bolezni tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom.
6 The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
6 kombinacija z odobreno učinkovino proti N. gonorrhoeae, odporno na fluorokinolone, ni možna, ali na primere, ko drugo zdravljenje ni bilo uspešno.
Due to the potential risk of adverse effects on the cartilage in patients under the age of 18 years, and the fact that PID mostly affects young women, the existing wording of the contraindication in children and adolescents was further specified namely that it is contraindicated in patients below 18 years of age.
7 Zaradi možnega tveganja neželenih učinkov na hrustanec pri bolnikih, mlajših od 18 let, in dejstva, da pelvične vnetne bolezni prizadenejo zlasti mlade ženske, je bilo obstoječe besedilo kontraindikacije pri otrocih in mladostnikih podrobneje opredeljeno, in sicer tako, da je zdravilo kontraindicirano pri bolnikih, mlajših od 18 let.
No 1084/ 2003, for Avalox and associated names (See Annex 1).
1084/ 2003, za zdravilo Avalox in z njim povezana imena (glejte Dodatek I).
- The Committee considered that robust data is available showing the efficacy of Avalox in the
- Odbor je sklenil, da so na voljo trdni podatki, ki dokazujejo učinkovitost zdravila Avalox pri
Risk balance for Avalox and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable;
koristmi in tveganji za zdravilo Avalox in z njim povezana imena pri „ zdravljenju blagih do zmernih pelvičnih vnetnih bolezni, tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom “, upoštevaje omejitve glede empirične monoterapije, ugodno.
Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Avalox and associated names (see Annex I).
značilnosti zdravila ter ustreznih poglavij navodila za uporabo, kot je navedeno v Dodatku III za zdravilo Avalox in z njim povezana imena (glejte Dodatek I).
CLINICAL PARTICULARS
10 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
11 [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
12 [izmišljeno ime] 400 mg filmsko obložene tablete so preučevali v kliničnih študijah, v katerih je zdravljenje trajalo največ 14 dni.
Interference with culture test Moxifloxacin therapy may give false negative culture results for Mycobacterium spp. by suppression of mycobacterial growth.
14 Vpliv na test kulture Zaradi zdravljenja z moksifloksacinom so lahko rezultati testa kulture pri Mycobacterium spp. lažno negativni zaradi supresije rasti mikobakterije.
14 Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
15 Mejne vrednosti Kliničnih in laboratorijskih standardnih predpisovTM (CLSI- Clinical and Laboratory Standards InstituteTM) glede na preskušanje MIK in disk- difuzijsko metodo za Staphylococcus spp. in občutljive mikroorganizme (M100- S17, 2007) in mejne vrednosti glede na preskušanje MIK za anaerobne mikroorganizme (M11- A7, 2007):
15 Commonly susceptible species Aerobic Gram-positive micro-organisms Gardnerella vaginalis Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B) Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae* Streptococcus pyogenes* (Group A) Aerobic Gram-negative micro-organisms Haemophilus influenzae* Haemophilus parainfluenzae* Klebsiella pneumoniae*# Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms Fusobacterium spp.
16 splošno občutljive vrste aerobni, po Gramu pozitivni mikroorganizmi Gardnerella vaginalis Staphylococcus aureus * (občutljivi za meticilin) Streptococcus agalactiae (skupina B) Streptococcus skupine milleri * (S. anginosus, S. constellatus in S. intermedius) Streptococcus pneumoniae * Streptococcus pyogenes * (skupina A) aerobni, po Gramu negativni mikroorganizmi Haemophilus influenzae * Haemophilus parainfluenzae * Klebsiella pneumoniae * # Moraxella (Branhamella) catarrhalis * anaerobni mikroorganizmi Fusobacterium spp.
16 Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/ l is observed.
Po dajanju 400 mg odmerka je AUC 35 mg⋅h/ l.
As renal function decreases,
18 Farmakokinetika moksifloksacina se pri bolnikih z motnjami v delovanju ledvic (tudi z očistkom kreatinina > 20 ml/ min/ 1, 73 m2) pomembno ne razlikuje.
17 concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/ min/ 1.73 m2).
Z oslabitvijo ledvične funkcije se koncentracije presnovka M2 (glukoronid) povečajo do 2, 5- krat (očistek kreatinina < 30 ml/ min/ 1, 73 m2).
19 1.
19 NAVODILO ZA UPORABO
22 If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
Če ste pozabili vzeti zdravilo [izmišljeno ime] 400 mg filmsko obložene tablete
If you forget to take [Invented name] 400 mg film-coated tablets If you forget to take your tablet you should take it as soon as you remember on the same day.
23 Če ste pozabili vzeti tableto, jo morate vzeti isti dan takoj, ko se spomnite.
London, 14 August 2008 EMEA/ CHMP/ 524251/ 2008
London, 14. avgust 2008 EMEA/ CHMP/ 524245/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6( 12) ZA ZDRAVILO Avelox in povezana imena
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJ A ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Marketing autorisation Holder
Imetnik dovoljenja za promet
2 Germany
2 Država članica
Oral use
peroralna uporab
0.02 mg / 3 mg
3 Država članica
film-coated tablets
Izmišljeno ime
Luxembourg
Pot uporabe
4 Sweden
Švedska
7 ANNEX III
7 DODATEK III
8 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
8 Veljavni povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo so končne verzije besedil, sprejete med postopkom Koordinacijske skupine..
London, 17 June 2008 EMEA/ CHMP/ 332403/ 2008
London, 17. junija 2008 EMEA/ 340394/ 2008
OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR Belanette and associated names (see Annex I)
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 5( 11) 1 ZA zdravilo Belanette in z njim povezana imena (glejte Dodatek I)
Drospirenone + Ethinylestradiol
Drospirenon + Etinilestradiol
Belanette and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Zdravilo Belanette in z njim povezana imena je kombinirano peroralno kontracepcijsko sredstvo, ki vsebuje 0, 02 mg etinilestradiola in 3 mg drospirenona.
The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern.
Predlagana zasnova embalaže, t. i. denarnica z zdravilom in navodilom za uporabo, zavitima v prozorni celofan, naj bi predstavljala resno nevarnost za zdravje ljudi.
During their December 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 Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Med svojim zasedanjem decembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med koristmi in tveganji za zdravilo Belanette in z njim povezana imena ugodno, ter da ugovori, ki jih je podala Madžarska, ne bi smeli preprečiti odobritve vloge za spremembo in da naj bodo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice končne različice, dogovorjene med postopkom Skupine za usklajevanje.
1 Article 5(11) of Commission Regulation (EC) No 1084/ 2003 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1084/ 2003 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH Država članica
(Invented)
Imetnik dovoljenja za Promet z zdravilom
Pharmaceutical
Predlagatelj
Route of
Ime
State
Jakost
Authorisation Holder
Farmacevtska Pot oblika
Name
uporabe
form
Avstrija
Box 217 3640 AE Mijdrecht The Netherlands
Box 217 3640 AE Mijdrecht Nizozemska
Jeneweinova 51a, 617 00 Brno, Czech Republic
Jeneweinova 51a 617 00 Brno Češka
Bicamid- GRY 150 mg Filmtabletten
Bicamid- GRY 150 mg 150 Filmtabletten
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
TEVA Sweden AB PO Box 1070 SE - 25110 Helsingborg Švedska
2 Greece
Francija
Box 217 3640 AE Mijdrecht The Netherlands
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 Francija
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
Box 217 3640 AE Mijdrecht Nizozemska
TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
TEVA Magyarország Rt Rákóczi út 70- 72 Budapest, H- 1074 Madžarska
Italy
Jakost
Richard 7, 20143 Milano Italy
Richard 7, 20143 Milano Italija
TEVA Pharma B. V., Industrieweg 23, P. O.
Teva Pharma B. V.
Box 217 3640 AE Mijdrecht The Netherlands
Bicalutamide - Teva
Bicalutamide -Teva 150 mg plė vele dengtos tabletė s
150 mg
150 mg
150 mg plėvele dengtos tabletės
oral use
Nizozemska
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740-264 Porto Salvo, Portugal
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740- 264 Porto Salvo Portugalska
4 Slovenia
Slovenije
Ingers Industrial Solutions s. r. o., Jeneweinova 51 a 617 00 Brno, Tjeckien
Jeneweinova 51a 617 00 Brno Češka
5 ANNEX II
5 ZNANSTVENI ZAKLJUČKI
Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) are generic preparations containing bicalutamide as the active substance.
Bikalutamid 150 mg filmsko obložene tablete (Ingers Industrial Solutions s. r. o.) je generično zdravilo, ki vsebuje zdravilno učinkovino bikalutamid.
The Article 29 referral procedure was initiated due to concerns raised by Germany on the potential serious risk to public health regarding the benefit/ risk ratio of this product.
Postopek napotitve v skladu s členom 29 je bil sprožen zaradi pomislekov Nemčije glede potencialnega tveganja za javno zdravje, in sicer zaradi razmerja med tveganji in koristmi tega zdravila.
The scope of Bicaluplex Article 29 Referral concerns the benefit/ risk ration of both indications: treatment of locally advanced prostatic cancer and monotherapy in early treatment or as adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostate cancer.
Predmet postopka napotitve v skladu s členom 29 za zdravilo Bicaluplex se nanaša na razmerje med tveganji in koristmi pri obeh indikacijah: zdravljenje lokalno napredovalega raka prostate v obliki monoterapije pri zgodnjem zdravljenju ali kot dodatek k zdravljenju z radioterapijo ali radikalno prostatektomijo pri bolnikih z rakom prostate.
The Committee, considering the Casodex Referral (bicalutamide 150 mg) made under article 31 of Directive 2001/ 83/ EC for medicinal products containing bicalutamide, reached the conclusion that bicalutamide 150mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to: “ Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression”.
„ Bikalutamid 150 mg je indiciran bodisi samostojno ali kot dodatek k radikalni prostatektomiji ali radioterapiji pri bolnikih z lokalno napredovalim rakom prostate, pri katerih obstaja veliko tveganje za napredovanje bolezni “.
The CHMP concluded that the benefit/ risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
CHMP je zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo bikalutamid 150 mg, pri usklajeni omejeni indikaciji ugodno.
Based on these conclusions, the CHMP considered generic Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) acceptable for registration based on a positive benefit/ risk ratio of bicalutamide 150mg containing products as recently assessed in the Casodex Article 31 Referral.
Na podlagi teh zaključkov je CHMP sklenil, da so generične Bikalutamid 150 mg filmsko obložene tablete (Ingers Industrial Solutions s. r. o.) primerne za registracijo zaradi pozitivnega razmerja med tveganji in koristmi zdravil, ki vsebujejo bikalutamid 150 mg, kot je bilo nedavno ugotovljeno v postopku napotitve v skladu s členom 31 za zdravilo Casodex.
7 ANNEX III
7 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
8 SUMMARY OF PRODUCT CHARACTERISTICS
8 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
9 The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
9 Veljavno Povzetek glavnih značilnosti zdravila je zadnja različica, ki je bila pripravljena v postopku koordinacijske skupine z naslednjimi dopolnili.
Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Zdravilo Bicaluplex 150 mg tablete je indicirano bodisi kot monoterapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije pri bolnikih z lokalno napredovalim rakom prostate z visokim tveganjem napredovanja bolezni (glejte poglavje 5. 1).
Pharmacotherapeutic group: anti-androgens, ATC code:
Farmakoterapevtska skupina: antiandrogeni, ATC koda:
L02BB03 Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
Bikalutamid je nesteroidni antiandrogen brez drugih endokrinih učinkov.
Treatment discontinuation may result in anti- androgen withdrawal syndrome in some patients.
Prenehanje zdravljenja lahko pri nekaterih bolnikih povzroči „ antiandrogen odtegnitveni sindrom “.