HU226733B1 - Transdermal therapeutic system which contains a d2 agonist and which is provided for treating parkinsonism, and a method for the production thereof - Google Patents
Transdermal therapeutic system which contains a d2 agonist and which is provided for treating parkinsonism, and a method for the production thereof Download PDFInfo
- Publication number
- HU226733B1 HU226733B1 HU0101519A HUP0101519A HU226733B1 HU 226733 B1 HU226733 B1 HU 226733B1 HU 0101519 A HU0101519 A HU 0101519A HU P0101519 A HUP0101519 A HU P0101519A HU 226733 B1 HU226733 B1 HU 226733B1
- Authority
- HU
- Hungary
- Prior art keywords
- acrylate
- ethyl
- tetrahydro
- thienyl
- propyl
- Prior art date
Links
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- 206010034010 Parkinsonism Diseases 0.000 title 1
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- 238000006116 polymerization reaction Methods 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- NNHHDJVEYQHLHG-UHFFFAOYSA-N potassium silicate Chemical compound [K+].[K+].[O-][Si]([O-])=O NNHHDJVEYQHLHG-UHFFFAOYSA-N 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 239000012602 primary packaging material Substances 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- GRWFGVWFFZKLTI-UHFFFAOYSA-N rac-alpha-Pinene Natural products CC1=CCC2C(C)(C)C1C2 GRWFGVWFFZKLTI-UHFFFAOYSA-N 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 125000005372 silanol group Chemical group 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000012205 single-component adhesive Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 210000000434 stratum corneum Anatomy 0.000 description 1
- 210000003523 substantia nigra Anatomy 0.000 description 1
- 230000016978 synaptic transmission, cholinergic Effects 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000004489 tear production Effects 0.000 description 1
- 230000037317 transdermal delivery Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
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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
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7092—Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
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- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
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- 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
Description
Claims (17)
- SZABADALMI IGÉNYPONTOK1. Transzdermális gyógyászati rendszer, amely egy, a mátrix alkotóanyagaival szemben inért hátoldali réteget, egy (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)etil]-amino}-1-naftolt tartalmazó öntapadós mátrixréteget és egy, a felhasználás előtt eltávolítandó védőfóliát tartalmaz, azzal jellemezve, hogy a mátrixa) egy akrilát-, illetve szilikátalapú nemvizes polimer ragasztórendszerre épül,b) oldhatósága az (-)-5,6,7,8-tetrahidro-6-{propil[2-(2-tienil)-etil]-amino}-1-naftol szabad bázisra >5% (tömeg), ésc) az (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)-etil]amino}-1 -naftol szabad bázist hatásos mennyiségben tartalmazza.
- 2. Az 1. igénypont szerinti transzdermális gyógyászati rendszer, azzal jellemezve, hogy kevesebb mint 0,5% (tömeg) szervetlen szilikátrészecskét tartalmaz.
- 3. Az 1. igénypont szerinti transzdermális gyógyászati rendszer, azzal jellemezve, hogy kevesebb mint 0,05% (tömeg) szervetlen szilikátrészecskét tartalmaz.
- 4. Az 1. igénypont szerinti transzdermális gyógyászati rendszer, azzal jellemezve, hogy az akrilátalapú polimer ragasztó legalább kettő, a következőkben felsorolt monomerek közül kikerülő anyagot tartalmaz: akrilsav, akrilamid, hexil-akrilát, 2-etil-hexil-akrilát, hidroxi-etil-akrilát, oktil-akrilát, butil-akrilát, metil-akrilát, glicidil-akrilát, metakrilátsav, metakrilamid, hexil-metilakrilát, 2-etil-hexil-metakrilát, oktil-metakrilát, metilmetakrilát, glicidil-metakrilát, vinil-acetát vagy vinil-pirrolidon.
- 5. Az 1. igénypont szerinti transzdermális rendszer, amelyben a szilikonalapú polimer ragasztóanyag az (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)-etil]-amino}1-naftalenol oldódását javító, hidrofil polimer, vagy glicerin vagy glicerinszármazék formájú adalék anyagokat tartalmaz.
- 6. A 4. vagy 5. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy az (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)-etil]-amino}-1 -naftalenolnak az akrilátalapú polimer ragasztóanyagban mért koncentrációja 10-35 tömeg%, vagy a szilikonalapú polimer ragasztóanyagban mért koncentrációja 5-40 tömeg %.
- 7. A 6. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy az (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)-etil]-amino}-1-naftalenol bőrbe való permeációját javító anyagokat tartalmaz.
- 8. A 7. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy permeációt javító anyagként zsíralkoholt, zsírsavat, zsírsav-észtert, zsírsavamidot, glicerint vagy valamilyen származékát, N-metilpirrolidont, terpént vagy terpénszármazékot alkalmazunk.
- 9. A 8. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy permeációt javító anyagként olajsavat vagy öleil-alkoholt alkalmazunk.
- 10. Az 5. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy hidrofil polimerként poli(vinil-pirrolidon)-t, vinil-pirrolidon és vinil-acetát kopolimerjét, polietilénglikolt, polipropilénglikolt vagy etilén és vinil-acetát kopolimerjét alkalmazzuk.
- 11. A 10. igénypont szerinti transzdermális rendszer, azzal jellemezve, hogy hidrofil polimerként oldható poli(vinil-pirrolidon)-t alkalmazunk, amely a hatóanyag-tartalmú mátrixrétegben 1,5-5 tömeg%-ban van jelen.
- 12. Az 1. igénypont szerinti rendszer, azzal jellemezve, hogy a kohéziót javító inért töltőanyagokat tartalmaz.
- 13. Eljárás transzdermális gyógyászati rendszer előállítására, amelynek soráni) az (-)-5,6,7,8-tetrahidro-6-{propil-[2-(2-tienil)-etiljamino}-1-naftalenol-hidroklorid etanolos szuszpenzióját egy alkalikus vegyület etanolos oldatával elkeverve a hidrokloridot szabad bázisformává alakítjuk, ii) a keletkező szuszpenziót adott esetben szűrjük, iii) a szűrlethez poli(vinil-pirrolidon)-t és egy ragasztóanyag-oldatot adunk, és iv) a terméket szárítjuk.
- 14. A 13. igénypont szerinti eljárás, azzal jellemezve, hogy alkalikus vegyületként nátrium-hidroxidot vagy kálium-hidroxidot alkalmazunk.
- 15. A 13. igénypont szerinti eljárás, azzal jellemezve, hogy alkalikus vegyületként nátrium- vagy káliummetaszilikátot vagy -triszilikátot alkalmazunk.
- 16. A 13. igénypont szerinti eljárás, azzal jellemezve, hogy a termék szárítása előtt a keveréket oly módon visszük fel egy inért hátoldali rétegre vagy védőfóliára, hogy egységes film keletkezik.
- 17. A 13-16. igénypontok bármelyike szerinti eljárással előállított termék.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE19814084A DE19814084B4 (de) | 1998-03-30 | 1998-03-30 | D2-Agonist enthaltendes transdermales therapeutisches System zur Behandlung des Parkinson-Syndroms und Verfahren zu seiner Herstellung |
PCT/EP1999/001795 WO1999049852A1 (de) | 1998-03-30 | 1999-03-18 | D2-agonist enthaltendes transdermales therapeutisches system zur behandlung des parkinson-syndroms und verfahren zu seiner herstellung |
Publications (3)
Publication Number | Publication Date |
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HUP0101519A2 HUP0101519A2 (hu) | 2001-09-28 |
HUP0101519A3 HUP0101519A3 (en) | 2002-10-28 |
HU226733B1 true HU226733B1 (en) | 2009-08-28 |
Family
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HU0101519A HU226733B1 (en) | 1998-03-30 | 1999-03-18 | Transdermal therapeutic system which contains a d2 agonist and which is provided for treating parkinsonism, and a method for the production thereof |
Country Status (31)
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US (4) | US6884434B1 (hu) |
EP (1) | EP1033978B1 (hu) |
JP (1) | JP3984785B2 (hu) |
KR (1) | KR100432276B1 (hu) |
CN (1) | CN1142773C (hu) |
AR (1) | AR014778A1 (hu) |
AT (1) | ATE210973T1 (hu) |
AU (1) | AU746856B2 (hu) |
BR (1) | BRPI9909313B8 (hu) |
CA (1) | CA2326630C (hu) |
CZ (1) | CZ297889B6 (hu) |
DE (4) | DE19814084B4 (hu) |
DK (1) | DK1033978T3 (hu) |
ES (1) | ES2170573T3 (hu) |
FR (1) | FR06C0025I2 (hu) |
HK (1) | HK1031196A1 (hu) |
HU (1) | HU226733B1 (hu) |
ID (1) | ID26646A (hu) |
IL (1) | IL138722A (hu) |
LU (1) | LU91269I2 (hu) |
MY (1) | MY119660A (hu) |
NL (1) | NL300236I2 (hu) |
NO (3) | NO325766B1 (hu) |
NZ (1) | NZ507066A (hu) |
PL (1) | PL193074B1 (hu) |
PT (1) | PT1033978E (hu) |
SK (1) | SK284618B6 (hu) |
TR (1) | TR200002829T2 (hu) |
TW (1) | TW579299B (hu) |
WO (1) | WO1999049852A1 (hu) |
ZA (1) | ZA200005261B (hu) |
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DE10334188B4 (de) | 2003-07-26 | 2007-07-05 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung von Depressionen |
DE10334187A1 (de) | 2003-07-26 | 2005-03-03 | Schwarz Pharma Ag | Substituierte 2-Aminotetraline zur Behandlung von Depressionen |
US7379762B2 (en) | 2003-09-04 | 2008-05-27 | Creative Technology Ltd. | Portable digital device orientation |
DE10359528A1 (de) | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
EP1547592A1 (en) | 2003-12-23 | 2005-06-29 | Schwarz Pharma Ag | Intranasal formulation of rotigotine |
DE10361258A1 (de) | 2003-12-24 | 2005-07-28 | Schwarz Pharma Ag | Verwendung von substituierten 2-Aminotetralinen zur vorbeugenden Behandlung von Morbus Parkinson |
US20050197385A1 (en) | 2004-02-20 | 2005-09-08 | Schwarz Pharma Ag | Use of rotigotine for treatment or prevention of dopaminergic neuron loss |
DE102004014841B4 (de) | 2004-03-24 | 2006-07-06 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung und Prävention des Parkinson-Plus-Syndroms |
US20060024362A1 (en) | 2004-07-29 | 2006-02-02 | Pawan Seth | Composition comprising a benzimidazole and process for its manufacture |
TWI392670B (zh) | 2006-06-22 | 2013-04-11 | Ucb Pharma Gmbh | 經取代的2-胺基萘滿之於製造用於預防、減緩及/或治療各種類型疼痛之藥物上的用途 |
EP1987815A1 (en) | 2007-05-04 | 2008-11-05 | Schwarz Pharma Ag | Oronasopharyngeally deliverable pharmaceutical compositions of dopamine agonists for the prevention and/or treatment of restless limb disorders |
ME02275B (me) | 2007-11-28 | 2016-02-20 | Ucb Pharma Gmbh | Polimorfni oblik rotigotina |
EP2281559A1 (en) | 2009-06-26 | 2011-02-09 | UCB Pharma GmbH | Pharmaceutical composition comprising rotigotine salts (acid or Na), especially for iontophoresis |
DK2515887T3 (en) | 2009-12-22 | 2018-09-17 | Ucb Biopharma Sprl | Polyvinylpyrrolidone to stabilize a solid dispersion of the non-crystalline form of rotigotine |
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1998
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1999
- 1999-03-18 HU HU0101519A patent/HU226733B1/hu active Protection Beyond IP Right Term
- 1999-03-18 KR KR10-2000-7010896A patent/KR100432276B1/ko active Protection Beyond IP Right Term
- 1999-03-18 AT AT99910359T patent/ATE210973T1/de active
- 1999-03-18 EP EP99910359A patent/EP1033978B1/de not_active Expired - Lifetime
- 1999-03-18 TR TR2000/02829T patent/TR200002829T2/xx unknown
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- 1999-03-18 WO PCT/EP1999/001795 patent/WO1999049852A1/de active IP Right Grant
- 1999-03-18 DE DE1999500581 patent/DE122006000035I1/de active Pending
- 1999-03-18 IL IL13872299A patent/IL138722A/xx not_active IP Right Cessation
- 1999-03-18 CZ CZ20003581A patent/CZ297889B6/cs not_active IP Right Cessation
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- 1999-03-18 CN CNB998047511A patent/CN1142773C/zh not_active Expired - Lifetime
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2000
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GB9A | Succession in title |
Owner name: SCHWARZ PHARMA LIMITED, IE Free format text: FORMER OWNER(S): DISCOVERY THERAPEUTICS, INC., US; ADERIS PHARMACEUTICALS, INC., US Owner name: LTS LOHMANN THERAPIE-SYSTEME AG., DE Free format text: FORMER OWNER(S): DISCOVERY THERAPEUTICS, INC., US; ADERIS PHARMACEUTICALS, INC., US |
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Free format text: PRODUCT NAME: ROTIGOTINE AND IT'S PHARMACEUTICALLY ACCEPTABLE SALTS; REG. NO/DATE:; FIRST REG.: EU EU/1/05/331/001-013 20060215 Spc suppl protection certif: S0900012 Filing date: 20090730 Expiry date: 20190318 Free format text: PRODUCT NAME: ROTIGOTINE (NEUPRO) ; FIRST REGISTRATION NUMBER AND DATE: EU/1/05/331/001-013 20060215 Spc suppl protection certif: S0900012 Filing date: 20090730 Expiry date: 20190318 |
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Free format text: PRODUCT NAME: ROTIGOTINE AND IT'S PHARMACEUTICALLY ACCEPTABLE SALTS; REG. NO/DATE: EU/1/05/331/001-013 20060215 Spc suppl protection certif: S0900012 Filing date: 20090730 Expiry date: 20190318 Extension date: 20210214 |
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Owner name: UCB BIOPHARMA SPRL, BE Free format text: FORMER OWNER(S): UCB MANUFACTURING IRELAND LIMITED, IE; ADERIS PHARMACEUTICALS, INC., US; DISCOVERY THERAPEUTICS, INC., US; SCHWARZ PHARMA LIMITED, IE Owner name: LTS LOHMANN THERAPIE-SYSTEME AG., DE Free format text: FORMER OWNER(S): UCB MANUFACTURING IRELAND LIMITED, IE; ADERIS PHARMACEUTICALS, INC., US; DISCOVERY THERAPEUTICS, INC., US; SCHWARZ PHARMA LIMITED, IE |