HRP20120665T1 - Farmaceutski pripravci od rifaksimina - Google Patents
Farmaceutski pripravci od rifaksimina Download PDFInfo
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- HRP20120665T1 HRP20120665T1 HRP20120665AT HRP20120665T HRP20120665T1 HR P20120665 T1 HRP20120665 T1 HR P20120665T1 HR P20120665A T HRP20120665A T HR P20120665AT HR P20120665 T HRP20120665 T HR P20120665T HR P20120665 T1 HRP20120665 T1 HR P20120665T1
- Authority
- HR
- Croatia
- Prior art keywords
- controlled release
- oral pharmaceutical
- pharmaceutical preparation
- cellulose
- release according
- Prior art date
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- NZCRJKRKKOLAOJ-XRCRFVBUSA-N rifaximin Chemical group OC1=C(C(O)=C2C)C3=C4N=C5C=C(C)C=CN5C4=C1NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@H](C)[C@@H](OC)\C=C\O[C@@]1(C)OC2=C3C1=O NZCRJKRKKOLAOJ-XRCRFVBUSA-N 0.000 title claims 7
- 229960003040 rifaximin Drugs 0.000 title claims 7
- 239000008194 pharmaceutical composition Substances 0.000 title 1
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
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- 210000004400 mucous membrane Anatomy 0.000 claims 1
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 claims 1
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- 229920001281 polyalkylene Polymers 0.000 claims 1
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Classifications
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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- A—HUMAN NECESSITIES
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- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P1/12—Antidiarrhoeals
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Claims (24)
1. Oralni farmaceutski pripravak s kontroliranim oslobađanjem, koji se sastoji od višeslojne tablete naznačen time da se najmanje jedan sloj sastoji od polimera za kontrolu oslobađanja i rifaksimina ili farmaceutski prihvatljive (prihvatljivih) soli ili njihovih enantiomera ili polimorfa i da se najmanje jedan sloj sastoji od nekog bioadhezivnog polimera, pri čemu svaki sloj uključuje jednu ili više pomoćnih tvari.
2. Oralni farmaceutski pripravak s kontroliranim oslobađanjem prema zahtjevu 1, naznačen time da je taj pripravak formuliran na način da se produlji vrijeme zadržavanja rifaksimina u probavnom sustavu.
3. Oralni farmaceutski pripravak s kontroliranim oslobađanjem prema zahtjevu 2, naznačen time da se produljenje vremena zadržavanja rifaksimina u probavnom sustavu postiže bioadhezijom.
4. Oralni farmaceutski pripravak s kontroliranim oslobađanjem prema zahtjevu 1, naznačen time da se bioadhezija postiže polimerima koji imaju afinitet prema sluznici probavnog sustava a odabiru se između polikarbofila, karbomera, lektina, pektina, zeina, modificiranog zeina, kazeina, želatine, glutena, serumskog albumina, kolagena, hitozana, oligosaharida i polisaharida kao što je celuloza i njeni derivati kao što je metil celuloza, etil celuloza, hidroksipropil celuloza, hidroksipropilmetil celuloza, hidroksibutilmetil celuloza, celulozni acetat, celulozni propionat, celulozni acetat butirat, celulozni acetat ftalat, karboksimetil celuloza, celulozni triacetat, celulozni sulfat natrijeva sol, dekstrani, polisaharid iz sjemenski tamarinda, gelan, karagenan; hijaluronska kiselina, polihijaluronska kiselina, alginska kiselina, natrijev alginat; gume kao što su ksantanska guma, guar guma, gumi-arabika, guma od sjemenki rogača; polivinil acetat, polivinil alkohol, povidon/polietilen oksid, akrilna i metakrilna kiselina i njihovi kopolimeri, poliamidi, polikarbonati, polialkileni, polialkilen glikoli, polialkilen oksidi, polialkilen tereftalati, polivinil alkoholi, polivinil eteri, polivinil esteri, polivinil halidi, polivinil pirolidon, poliglikolidi, polisiloksani, poliuretani, polistiren, polimeri akrilnih i metakrilnih estera, polilaktidi, poli(buterna kiselina), poli(valerijanska kiselina), poli(laktid-ko-glikolid), polianhidridi, poliortoesteri, poli(fumarna kiselina), poli(maleična kiselina), polimeri koji imaju hidrofobnu okosnicu s najmanje jednom bočnom hidrofilnom skupinom, polimeri koji imaju hidrofobnu okosnicu s najmanje jednom bočnom hidrofobnom skupinom, te smjese i kopolimeri ili mješavine istih.
5. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1, naznačen time da polimer za kontrolu oslobađanja u sebi sadrži hidrofilni polimer za kontrolu brzine oslobađanja ili hidrofobni polimer za kontrolu brzine oslobađanja i kombinacije istih.
6. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 5, naznačen time da se hidrofilni polimer za regulaciju brzine oslobađanja odabire između ugljikohidrata poput celuloze, kao što je etil celuloza, hidroksipropil celuloza, hidroksipromilmetil celuloza, hidroksipropiletil celuloza; gume poput ksantanske gume, guar gume, gume iz sjemenki rogača; alginata; ugljika, polivinil acetata, polivinil alkohola, povidon/polietilen oksida, kopolimera akrilne i metakrilne kiseline ili mješavina istih.
7. Oralni farmaceutski pripravak s kontroliranim oslobađanjem prema zahtjevu 1, naznačen time da nadalje sadrži sredstvo (sredstva) za otapanje koja se odabiru između surfaktanata kao što su neionske, semipolarne, anionske, kationske, amfoterne ili zwitterionske površinski aktivne tvari topive u vodi; ciklodekstrin i njegovi derivati; lipofilne tvari; vitamin E i njegovi derivati; esteri nižih alkohola i masnih kiselina; otapala koja sadrže dušik; fosfolipidi; glicerol acetati kao što su acetin, diacetin i triacetin, esteri glicerola i masne kiselina kao što su mono-, di- i trigliceridi te acetilirani mono- i digliceridi; esteri propilen glikola; esteri etilen glikola ili bilo koja kombinacija istih.
8. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1, naznačen time da se farmaceutski prihvatljive pomoćne tvari odabiru između sredstava za vezivanje, razrjeđivanje, podmazivanje, površinski aktivnih tvari ili tvari za postizanje klizavosti.
9. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 8, naznačen time da je vezivno sredstvo jedno ili više njih, odabranih između ugljikohidrata kao što su celuloze; škrobovi; gume; polivinil pirolidon, povidon, sirup, polietilen oksid, poliakril amid, poli-N-vinil amid, natrij karbosimetil celuloza, polietilen glikol, želatina, polietilen oksid, polipropilen glikol, tragakant, alginska kiselina ili kombinacije istih.
10. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 8, naznačen time da je sredstvo za razrjeđivanje jedno ili više njih, odabranih između ugljikohidrata, derivata ugljikohidrata, poliola, šećernih alkohola, karbonatnih, sulfatnih ili fosfatnh soli anorganskih metala ili mješavine istih.
11. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 8, naznačen time da je sredstvo za podmazivanje jedno ili više njih, odabranih između magnezijevog, aluminijevog, cinkovog ili kalcijevog stearata, natrij stearil fumarata, polietilen glikola, mineralnog ulja, stearinske kiseline, hidrogeniziranog biljnog ulja, gliceril behenata, gliceril palmitostearata, gliceril stearata, kukuruznog škroba, talka, kalcijevog silikata, magnezijevog silikata, koloidnog silicijevog dioksida, silicijevog hidrogela ili mješavina istih.
12. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 8, naznačen time da je površinski aktivna tvar jedna ili više njih, odabranih između ionskih ili neionskih ili zwitterionskih površinski aktivnih tvari.
13. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 8, naznačen time da je tvar za postizanje klizavosti jedna ili više njih, odabranih između silicijevog dioksida, koloidne silike, celuloze u prahu, talka, trobaznog kalcijevog fosfata ili mješavina istih.
14. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da je u obliku jednokratne dnevne doze.
15. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da je u obliku jednokratne dnevne doze koja sadrži 20 do 2400mg rifaksimina.
16. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da je u obliku jednokratne dnevne doze koja sadrži 550mg rifaksimina.
17. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da je u obliku jednokratne dnevne doze koja sadrži 600mg rifaksimina.
18. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da služi za povećanje spremnosti pacijenta za liječenje putnih proljeva, hepatičke encefalopatije, zaraznih proljeva, divertikularne bolesti, za antibakterijsku profilaksu prije operacije debelog crijeva, za liječenje sindroma nadražljivih crijeva, Crohnove bolesti, proljeva uzrokovanog bakterijom Clostridium difficile, prekomjernog broja bakterija u tankom crijevu, za profilaksu putnih proljeva, za liječenje dizenterije, pouchitisa (upale kirurški oblikovane crijevne vrećice), za predoperativnu profilaksu i za liječenje želučane dispepsije.
19. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da je za uporabu u liječenju putnih proljeva, hepatičke encefalopatije, zaraznih proljeva, divertikularne bolesti, za antibakterijsku profilaksu prije operacije debelog crijeva, za liječenje sindroma nadražljivih crijeva, Crohnove bolesti, proljeva uzrokovanog bakterijom Clostridium difficile, prekomjernog broja bakterija u tankom crijevu, za profilaksu putnog proljeva, za liječenje dizenterije, pouchitisa (upale kirurški oblikovane crijevne vrećice), za predoperativnu profilaksu i za liječenje želučane dispepsije.
20. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1, naznačen time da je za uporabu u liječenju putnih proljeva.
21. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1, naznačen time da je za uporabu u liječenju putnih proljeva kojima je uzročnik E. coli.
22. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 14, naznačen time da je za uporabu u liječenju putnih proljeva kojima je uzročnik Klebsiella.
23. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 1 naznačen time da dodatno je obložen pri čemu ta obloga uključuje film, šećerni premaz, enterički premaz, bioadhezivni ili mukoadhezivni premaz.
24. Oralni farmaceutski pripravak s kontroliranim oslobađanjem u skladu sa zahtjevom 23, naznačen time da sloj obloge sadrži sredstva za oblaganje, plastifikatore, sredstva protiv sljepljivanja, površinski aktivne tvari, bojila, sredstva za postizanje neprozirnosti ili mješavine istih.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN968KO2007 | 2007-07-06 | ||
| EP08252158 | 2008-06-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20120665T1 true HRP20120665T1 (hr) | 2012-10-31 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20120665AT HRP20120665T1 (hr) | 2007-07-06 | 2012-08-17 | Farmaceutski pripravci od rifaksimina |
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| Country | Link |
|---|---|
| EP (4) | EP2011486B2 (hr) |
| CY (1) | CY1113068T1 (hr) |
| DK (1) | DK2011486T3 (hr) |
| ES (3) | ES2798253T3 (hr) |
| HR (1) | HRP20120665T1 (hr) |
| PL (1) | PL2011486T5 (hr) |
| PT (1) | PT2011486E (hr) |
| SI (1) | SI2011486T1 (hr) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20032144A1 (it) | 2003-11-07 | 2005-05-08 | Alfa Wassermann Spa | Forme polimorfe di rifaximina, processi per ottenerle e |
| US7902206B2 (en) | 2003-11-07 | 2011-03-08 | Alfa Wassermann, S.P.A. | Polymorphic forms α, β and γ of rifaximin |
| US7906542B2 (en) | 2004-11-04 | 2011-03-15 | Alfa Wassermann, S.P.A. | Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin |
| DK1698630T3 (da) | 2005-03-03 | 2014-12-08 | Alfa Wassermann Spa | Nye polymorfe former af rifaximin, fremgangsmåde for deres fremstilling og anvendelse deraf i de medicinske præparater |
| ITBO20050123A1 (it) | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
| EP3620153A1 (en) * | 2007-07-06 | 2020-03-11 | Lupin Limited | Pharmaceutical compositions for gastrointestinal drug delivery |
| US20110035232A1 (en) | 2008-10-02 | 2011-02-10 | Salix Pharmaceuticals, Ltd. | Methods of treating hepatic encephalopathy |
| SI3628319T1 (sl) | 2008-10-02 | 2024-04-30 | Salix Pharmaceuticals, Ltd. | Zdravljenje jetrne encefalopatije z rifaksiminom |
| US7928115B2 (en) | 2008-10-02 | 2011-04-19 | Salix Pharmaceuticals, Ltd. | Methods of treating travelers diarrhea and hepatic encephalopathy |
| MX2011013427A (es) * | 2009-06-15 | 2012-04-20 | Salix Pharmaceuticals Ltd | Modulacion de exposicion sistemica a rifaximina. |
| KR20200100215A (ko) * | 2009-10-27 | 2020-08-25 | 루핀 리미티드 | 리팍시민의 고형 분산물 |
| US9018684B2 (en) | 2009-11-23 | 2015-04-28 | California Institute Of Technology | Chemical sensing and/or measuring devices and methods |
| IT1398550B1 (it) | 2010-03-05 | 2013-03-01 | Alfa Wassermann Spa | Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo |
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| ITBO20110461A1 (it) | 2011-07-29 | 2013-01-30 | Alfa Wassermann Spa | Composizioni farmaceutiche comprendenti rifaximina, processi per la loro preparazione e loro uso nel trattamento di infezioni vaginali. |
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| WO2018064472A1 (en) * | 2016-09-30 | 2018-04-05 | Salix Pharmaceuticals, Ltd. | Solid dispersion forms of rifaximin |
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| US11129862B2 (en) | 2017-08-30 | 2021-09-28 | Johnson & Johnson Consumer Inc. | Ophthalmic compositions |
| CN108658673A (zh) * | 2018-06-27 | 2018-10-16 | 安徽瑞然生物药肥科技有限公司 | 一种用于缓释肥料的包膜材料及其制备方法 |
| CN109021187B (zh) * | 2018-08-24 | 2019-09-06 | 中山大学 | 玉米醇溶蛋白-聚磺基甜菜碱两亲性缀合物及其制备方法与应用 |
| CN109663150B (zh) * | 2018-12-29 | 2022-01-14 | 广州贝奥吉因生物科技股份有限公司 | 一种心肌修复水凝胶材料及其制备方法 |
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| IT1154655B (it) | 1980-05-22 | 1987-01-21 | Alfa Farmaceutici Spa | Derivati imidazo-rifamicinici metodi per la loro preparazione e loro uso come sostanza ad azione antibatterica |
| IT1253711B (it) * | 1991-12-17 | 1995-08-23 | Alfa Wassermann Spa | Formulazioni farmaceutiche vaginali contenenti rifaximin e loro uso nel trattamento delle infezioni vaginali |
| IT1264494B1 (it) † | 1993-03-23 | 1996-09-24 | Alfa Wassermann Spa | Uso di rifaximin e di formulazioni che la contengono nel trattamento delle dispepsie gastriche originate da helicobacter |
| ITMI20032144A1 (it) * | 2003-11-07 | 2005-05-08 | Alfa Wassermann Spa | Forme polimorfe di rifaximina, processi per ottenerle e |
| ITMI20041295A1 (it) † | 2004-06-25 | 2004-09-25 | Cosmo Spa | Composizioni farmaceutiche antimicrobiche orali |
| US20060045865A1 (en) † | 2004-08-27 | 2006-03-02 | Spherics, Inc. | Controlled regional oral delivery |
| ITBO20050123A1 (it) * | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
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2008
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- 2008-06-26 ES ES11176043T patent/ES2798253T3/es active Active
- 2008-06-26 PL PL08252198.0T patent/PL2011486T5/pl unknown
- 2008-06-26 EP EP08252198.0A patent/EP2011486B2/en active Active
- 2008-06-26 EP EP14186563.4A patent/EP2837378A1/en not_active Withdrawn
- 2008-06-26 PT PT08252198T patent/PT2011486E/pt unknown
- 2008-06-26 SI SI200830741T patent/SI2011486T1/sl unknown
- 2008-06-26 EP EP20160395.8A patent/EP3714878B1/en active Active
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2012
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- 2012-08-23 CY CY20121100760T patent/CY1113068T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3714878B1 (en) | 2022-01-19 |
| PL2011486T3 (pl) | 2013-01-31 |
| ES2389358T3 (es) | 2012-10-25 |
| PL2011486T5 (pl) | 2016-09-30 |
| EP2011486B1 (en) | 2012-05-23 |
| ES2905795T3 (es) | 2022-04-12 |
| EP3714878A1 (en) | 2020-09-30 |
| PT2011486E (pt) | 2012-08-24 |
| CY1113068T1 (el) | 2016-04-13 |
| DK2011486T3 (da) | 2012-09-03 |
| EP2837378A1 (en) | 2015-02-18 |
| EP2420226A1 (en) | 2012-02-22 |
| EP2011486A1 (en) | 2009-01-07 |
| ES2389358T5 (es) | 2016-01-19 |
| EP2420226B1 (en) | 2020-03-04 |
| SI2011486T1 (sl) | 2012-10-30 |
| ES2798253T3 (es) | 2020-12-10 |
| EP2011486B2 (en) | 2015-08-12 |
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