HRP20171708T1 - FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (1R,4R)-6'-FLUORO-N,N-DIMETIL-4-FENIL-4',9'-DIHIDRO-3'H-SPIRO[CIKLOHEKSAN-1,1'-PIRANO [3,4,b]INDOL]-4-AMIN I GABAPENTINOID - Google Patents
FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (1R,4R)-6'-FLUORO-N,N-DIMETIL-4-FENIL-4',9'-DIHIDRO-3'H-SPIRO[CIKLOHEKSAN-1,1'-PIRANO [3,4,b]INDOL]-4-AMIN I GABAPENTINOID Download PDFInfo
- Publication number
- HRP20171708T1 HRP20171708T1 HRP20171708TT HRP20171708T HRP20171708T1 HR P20171708 T1 HRP20171708 T1 HR P20171708T1 HR P20171708T T HRP20171708T T HR P20171708TT HR P20171708 T HRP20171708 T HR P20171708T HR P20171708 T1 HRP20171708 T1 HR P20171708T1
- Authority
- HR
- Croatia
- Prior art keywords
- pain
- pharmacologically active
- active ingredient
- dosage form
- prevention
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- SIKJAQJRHWYJAI-UHFFFAOYSA-N Indole Chemical compound C1=CC=C2NC=CC2=C1 SIKJAQJRHWYJAI-UHFFFAOYSA-N 0.000 title 1
- 208000002193 Pain Diseases 0.000 claims 18
- 239000002831 pharmacologic agent Substances 0.000 claims 13
- 239000002552 dosage form Substances 0.000 claims 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 230000002265 prevention Effects 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 3
- UGJMXCAKCUNAIE-UHFFFAOYSA-N Gabapentin Chemical compound OC(=O)CC1(CN)CCCCC1 UGJMXCAKCUNAIE-UHFFFAOYSA-N 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- 206010006002 Bone pain Diseases 0.000 claims 1
- 206010058019 Cancer Pain Diseases 0.000 claims 1
- 208000000094 Chronic Pain Diseases 0.000 claims 1
- 206010019233 Headaches Diseases 0.000 claims 1
- 206010065390 Inflammatory pain Diseases 0.000 claims 1
- 208000008930 Low Back Pain Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 229960002870 gabapentin Drugs 0.000 claims 1
- 231100000869 headache Toxicity 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000007912 intraperitoneal administration Methods 0.000 claims 1
- 238000007913 intrathecal administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 230000003387 muscular Effects 0.000 claims 1
- 230000002981 neuropathic effect Effects 0.000 claims 1
- 230000003040 nociceptive effect Effects 0.000 claims 1
- 230000002093 peripheral effect Effects 0.000 claims 1
- 230000002980 postoperative effect Effects 0.000 claims 1
- AYXYPKUFHZROOJ-ZETCQYMHSA-N pregabalin Chemical compound CC(C)C[C@H](CN)CC(O)=O AYXYPKUFHZROOJ-ZETCQYMHSA-N 0.000 claims 1
- 229960001233 pregabalin Drugs 0.000 claims 1
- 230000001107 psychogenic effect Effects 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 230000002195 synergetic effect Effects 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- PJDFLNIOAUIZSL-UHFFFAOYSA-N vigabatrin Chemical compound C=CC(N)CCC(O)=O PJDFLNIOAUIZSL-UHFFFAOYSA-N 0.000 claims 1
- 229960005318 vigabatrin Drugs 0.000 claims 1
- 208000009935 visceral pain Diseases 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
1. Farmaceutski pripravak naznačen time da je za uporabu za sprječavanje ili liječenje boli koji sadrži:
a) prvi farmakološki aktivni sastojak izabran od spoja prema kemijskoj formuli (I) i njihove fiziološki prihvatljive soli
[image]
i
b) drugi farmakološki aktivni sastojak izabran od gabapentinoida i njihovih fiziološki prihvatljivih soli.
2. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 1, naznačen time da je prvi farmakološki aktivni sastojak spoj prema kemijskoj formuli (I)
[image]
3. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 1 ili 2, naznačen time da je drugi farmakološki aktivni sastojak odabran iz skupine koja sadrži pregabalin, gabapentin, vigabatrin i njihove fiziološki prihvatljive soli.
4. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži prvi i drugi farmakološki aktivni sastojak u takvom masenom omjeru da će nakon davanja pacijentu imati sinergističko terapeutsko djelovanje.
5. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema bilo kojem od prethodnih zahtjeva, naznačen time da je relativni omjer mase prvog farmakološki aktivnog sastojka prema drugom farmakološki aktivnom sastojku unutar raspona od 1:30 do 1 : 1,000,000.
6. Farmaceutski pripravak za uporabu za sprječavanje ili liječenje boli prema zahtjevu 5, naznačen time da bol je:
- periferna, središnja ili mišićna skeletna bol; i/ili
- akutna, subakutna ili kronična bol; i/ili
- umjerena do jaka bol; i/ili
- neuropatska ili psihogena ili nociceptivna ili miješana bol; i/ili
- bol u donjem dijelu leđa, visceralna bol ili glavobolja; i/ili
- postoperativna (post-kirurška) bol, rak ili upalna bol
7. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli naznačen time da sadrži farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva.
8. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema zahtjevu 7, naznačen time da sadrži prvi farmakološki aktivni sastojak u dozi od 10 do 1,200 µg.
9. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema zahtjevu 7 ili 8, naznačen time da sadrži drugi farmakološki aktivni sastojak u dozi od 0.05 do 5 g.
10. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema bilo kojem od zahtjeva 7 do 9, naznačen time da je doziranje prvog farmakološki aktivnog sastojka u rasponu od 1:20 do 20:1 količine koja je ekvivalentno djelotvorna doziranju drugog farmakološki aktivnog sastojka.
11. Farmaceutski oblik doziranja za uporabu za sprječavanje ili liječenje boli prema bilo kojem od zahtjeva 7 do 10, naznačen time da je za oralnu, intravensku, intraperitonealnu, transdermalnu, intratekalnu, intramuskularnu, intranazalnu, transmukoznu, potkožnu ili rektalnu primjenu.
12. Komplet za uporabu za sprječavanje ili liječenje boli koji sadrži prvi farmaceutski oblik doziranja koji sadrži prvi farmakološki aktivni sastojak kako je definiran u zahtjevu 1 ili 2, te drugi farmaceutski oblik doziranja koji sadrži drugi farmakološki aktivni sastojak kako je definiran u patentnom zahtjevu 1 ili 3.
13. Komplet za uporabu za sprječavanje ili liječenje boli prema zahtjevu 12, naznačen time da su prvi i drugi farmaceutski oblik doziranja prilagođeni za istovremenu ili uzastopnu primjenu, bilo istim ili različitim putem primjene.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12003940 | 2012-05-18 | ||
PCT/EP2013/001465 WO2013170966A1 (en) | 2012-05-18 | 2013-05-16 | Pharmaceutical composition comprising (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano [3,4,b]indol]-4-amine and a gabapentinoid |
EP13726111.1A EP2849748B1 (en) | 2012-05-18 | 2013-05-16 | Pharmaceutical composition comprising (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano [3,4,b]indol]-4-amine and a gabapentinoid |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20171708T1 true HRP20171708T1 (hr) | 2017-12-29 |
Family
ID=48539081
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20171708TT HRP20171708T1 (hr) | 2012-05-18 | 2017-11-08 | FARMACEUTSKI PRIPRAVAK KOJI SADRŽI (1R,4R)-6'-FLUORO-N,N-DIMETIL-4-FENIL-4',9'-DIHIDRO-3'H-SPIRO[CIKLOHEKSAN-1,1'-PIRANO [3,4,b]INDOL]-4-AMIN I GABAPENTINOID |
Country Status (23)
Country | Link |
---|---|
US (2) | US9320725B2 (hr) |
EP (1) | EP2849748B1 (hr) |
JP (1) | JP6116673B2 (hr) |
CN (1) | CN104284658A (hr) |
AU (1) | AU2013262072B2 (hr) |
BR (1) | BR112014028574A2 (hr) |
CA (1) | CA2873624A1 (hr) |
CY (1) | CY1119777T1 (hr) |
DK (1) | DK2849748T3 (hr) |
EA (1) | EA029766B1 (hr) |
ES (1) | ES2658218T3 (hr) |
HK (1) | HK1204943A1 (hr) |
HR (1) | HRP20171708T1 (hr) |
HU (1) | HUE034659T2 (hr) |
IL (1) | IL235658A (hr) |
LT (1) | LT2849748T (hr) |
MX (1) | MX356245B (hr) |
NO (1) | NO2849748T3 (hr) |
PL (1) | PL2849748T3 (hr) |
PT (1) | PT2849748T (hr) |
RS (1) | RS56799B1 (hr) |
SI (1) | SI2849748T1 (hr) |
WO (1) | WO2013170966A1 (hr) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9320725B2 (en) | 2012-05-18 | 2016-04-26 | Gruenenthal Gmbh | Pharmaceutical composition comprising (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine and a gabapentinoid |
JP6673924B2 (ja) | 2015-01-23 | 2020-03-25 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 肝機能障害および/または腎機能障害を有する対象における疼痛を治療するためのセブラノパドール |
US10449090B2 (en) | 2015-07-31 | 2019-10-22 | Allotex, Inc. | Corneal implant systems and methods |
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HUE028436T2 (hu) * | 2010-08-04 | 2016-12-28 | Gruenenthal Gmbh | Gyógyszerészeti adagolási forma, amely tartalmaz-6'-fluor-(N-metil- vagy N,N-dimetil)-4-fenil-4',9'-dihidro-3'H-spiro[ciklohexán-1,1'-pirano[3,4B]indol]-4-amint |
SI2600838T1 (sl) * | 2010-08-04 | 2015-12-31 | Gruenenthal Gmbh | Farmacevtska odmerna oblika, ki obsega 6'-fluoro-(N-metil- ali N,N-dimetil-)-4-fenil-4',9'-dihidro-3'H-spiro(cikloheksan-1,1'-pirano (3,4,b)indol)-4-amin |
DK2600851T3 (en) * | 2010-08-04 | 2018-06-25 | Gruenenthal Gmbh | PHARMACEUTICAL DOSAGE FORM CONTAINING 6'-FLUORO- (N-METHYL OR N, N-DIMETHYL -) - 4-PHENYL-4 ', 9'-DIHYDRO-3'H-SPIRO [CYCLOHEXAN-1,1'-PYRANO [3,4, B] INDOL] -4-AMINE FOR TREATMENT OF NEUROPATHIC PAIN |
US9320725B2 (en) | 2012-05-18 | 2016-04-26 | Gruenenthal Gmbh | Pharmaceutical composition comprising (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine and a gabapentinoid |
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2013
- 2013-05-13 US US13/892,968 patent/US9320725B2/en active Active
- 2013-05-16 AU AU2013262072A patent/AU2013262072B2/en not_active Ceased
- 2013-05-16 EP EP13726111.1A patent/EP2849748B1/en active Active
- 2013-05-16 LT LTEP13726111.1T patent/LT2849748T/lt unknown
- 2013-05-16 SI SI201330920T patent/SI2849748T1/en unknown
- 2013-05-16 RS RS20180083A patent/RS56799B1/sr unknown
- 2013-05-16 PT PT137261111T patent/PT2849748T/pt unknown
- 2013-05-16 CA CA2873624A patent/CA2873624A1/en not_active Abandoned
- 2013-05-16 HU HUE13726111A patent/HUE034659T2/en unknown
- 2013-05-16 ES ES13726111.1T patent/ES2658218T3/es active Active
- 2013-05-16 DK DK13726111.1T patent/DK2849748T3/en active
- 2013-05-16 PL PL13726111T patent/PL2849748T3/pl unknown
- 2013-05-16 MX MX2014012764A patent/MX356245B/es active IP Right Grant
- 2013-05-16 EA EA201401268A patent/EA029766B1/ru not_active IP Right Cessation
- 2013-05-16 WO PCT/EP2013/001465 patent/WO2013170966A1/en active Application Filing
- 2013-05-16 NO NO13726111A patent/NO2849748T3/no unknown
- 2013-05-16 JP JP2015511952A patent/JP6116673B2/ja active Active
- 2013-05-16 CN CN201380025640.1A patent/CN104284658A/zh active Pending
- 2013-05-16 BR BR112014028574A patent/BR112014028574A2/pt not_active IP Right Cessation
-
2014
- 2014-11-12 IL IL235658A patent/IL235658A/en active IP Right Grant
-
2015
- 2015-06-11 HK HK15105574.6A patent/HK1204943A1/xx not_active IP Right Cessation
-
2016
- 2016-03-15 US US15/070,797 patent/US9629825B2/en active Active
-
2017
- 2017-11-08 HR HRP20171708TT patent/HRP20171708T1/hr unknown
-
2018
- 2018-01-16 CY CY20181100050T patent/CY1119777T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
AU2013262072B2 (en) | 2018-01-18 |
SI2849748T1 (en) | 2018-02-28 |
US9320725B2 (en) | 2016-04-26 |
HK1204943A1 (en) | 2015-12-11 |
CY1119777T1 (el) | 2018-06-27 |
BR112014028574A2 (pt) | 2017-06-27 |
US9629825B2 (en) | 2017-04-25 |
MX356245B (es) | 2018-05-21 |
RS56799B1 (sr) | 2018-04-30 |
IL235658A0 (en) | 2015-01-29 |
CN104284658A (zh) | 2015-01-14 |
AU2013262072A1 (en) | 2015-01-22 |
CA2873624A1 (en) | 2013-11-21 |
EA029766B1 (ru) | 2018-05-31 |
US20130310434A1 (en) | 2013-11-21 |
JP2015516446A (ja) | 2015-06-11 |
PL2849748T3 (pl) | 2018-03-30 |
PT2849748T (pt) | 2018-02-07 |
IL235658A (en) | 2017-07-31 |
MX2014012764A (es) | 2014-11-21 |
US20160193183A1 (en) | 2016-07-07 |
JP6116673B2 (ja) | 2017-04-19 |
LT2849748T (lt) | 2018-01-25 |
HUE034659T2 (en) | 2018-02-28 |
EA201401268A1 (ru) | 2015-06-30 |
ES2658218T3 (es) | 2018-03-08 |
NO2849748T3 (hr) | 2018-03-31 |
EP2849748B1 (en) | 2017-11-01 |
EP2849748A1 (en) | 2015-03-25 |
DK2849748T3 (en) | 2017-12-04 |
WO2013170966A1 (en) | 2013-11-21 |
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