EP1126888A1 - Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques - Google Patents

Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques

Info

Publication number
EP1126888A1
EP1126888A1 EP99971721A EP99971721A EP1126888A1 EP 1126888 A1 EP1126888 A1 EP 1126888A1 EP 99971721 A EP99971721 A EP 99971721A EP 99971721 A EP99971721 A EP 99971721A EP 1126888 A1 EP1126888 A1 EP 1126888A1
Authority
EP
European Patent Office
Prior art keywords
container
connection
pharmaceutical dosage
dosage form
connections
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP99971721A
Other languages
German (de)
English (en)
Other versions
EP1126888B1 (fr
Inventor
Peter Schaffer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda GmbH
Original Assignee
Byk Gulden Lomberg Chemische Fabrik GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Byk Gulden Lomberg Chemische Fabrik GmbH filed Critical Byk Gulden Lomberg Chemische Fabrik GmbH
Publication of EP1126888A1 publication Critical patent/EP1126888A1/fr
Application granted granted Critical
Publication of EP1126888B1 publication Critical patent/EP1126888B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes

Definitions

  • the invention relates to a device for blinding the administration of non-solid pharmaceutical dosage forms in clinical trials on mammals.
  • the pharmaceutical dosage form is a colorless liquid
  • the pharmaceutical dosage form can be replaced, for example, by a physiological sodium chloride solution.
  • an opaque application system can be used for administration. It is understood that these methods are not suitable for intrapulmonary administration.
  • the double blind technique double observer technique
  • the object of the present invention is to provide a device which enables the administration of non-solid pharmaceutical dosage forms to be blinded in clinical trials in a simple manner and without using the double-blind technique.
  • the invention therefore relates to a device for blinding the administration of non-solid pharmaceutical dosage forms during clinical trials on mammals.
  • the device is an opaque container that has at least two ports, one of which is suitable for connection to a delivery device for the pharmaceutical dosage form and the other for connection to one Application agent is suitable and the container has in its interior means for retaining the pharmaceutical dosage form (hereinafter also referred to as "non flow type" configuration).
  • the invention relates to an opaque container which has at least two connections, one of which is suitable for connection to a dispensing agent for the pharmaceutical dosage form and the other is suitable for connection to an application agent, and the connections inside the Containers have a continuous connection that ensures transport of the pharmaceutical dosage form through the container (hereinafter also referred to as "flow type" configuration).
  • the pharmaceutical dosage form - which is not recognizable to the person responsible for the administration - is transported through the container and administered to the patient.
  • the invention relates to a container which can enable both the transport of the pharmaceutical dosage form through the container and the retention of the pharmaceutical dosage form in the same container.
  • the invention therefore furthermore relates to an opaque container which has at least three connections, two of which are suitable for connection to a dispensing agent for the pharmaceutical dosage form and the third is suitable for connection to an application agent, the inside of the container being used for Retention of the pharmaceutical dosage form and one of the connections which are suitable for the connection with a delivery means inside the container has a continuous connection with the connection which is suitable for the connection with the application means and the connection ensures a transport of the pharmaceutical administration form through the container .
  • the pharmaceutical dosage form is either transported through the container and administered to the patient or retained in the container.
  • the container according to the invention can be rigid or flexible and can be made of all suitable solid materials.
  • it is a container that was made of plastic or rubber (for example, foil pouch that is made of PVC foil).
  • the means for retaining the pharmaceutical dosage form inside the container is preferably an absorbent material which can completely absorb the non-solid pharmaceutical dosage form (for example absorbent tissue).
  • the inside of the container can also be completely or partially hollow. Restraint can also be ensured in this way.
  • the container is preferably dimensioned such that it can completely accommodate the test substance to be administered. In a preferred embodiment of the invention, the container is dimensioned such that it can collect 300 ml of liquid.
  • Preferred are containers which have an internal volume of 500 ml to 3000 ml, particularly preferably those which have an internal volume of 1000 ml to 2000 ml.
  • the container should preferably have a correspondingly higher weight. This makes it difficult or impossible to compare the weight of the container before and after application of the test substance by the person entrusted with the administration of the substance. In this respect, containers with a dead weight of more than 1 kg have generally proven to be advantageous.
  • the container can have weight elements on the inside in order to ensure a sufficient weight of the container.
  • the weight elements can be hard rubber disks, for example.
  • the connections which the container according to the invention has are preferably commercially available Luer lock connections which are suitable for connection to the dispensing or application means.
  • the connections for differentiation preferably have different markings.
  • the dispensing means is preferably a commercially available syringe which can be connected directly or via a hose connection to the connection provided on the container.
  • the application agent is preferably an opaque application agent, for example an opaque catheter system, preferably a catheter system that is suitable for intrapulmonary application of a non-solid pharmaceutical dosage form. Such catheter systems are known to the person skilled in the art.
  • the container according to the invention which causes the pharmaceutical dosage form to be retained, can furthermore be connected at the connection which is intended for connection to the delivery means by means of a hose which leads into the interior of the container and has an open end through which the pharmaceutical Dosage form is released into the interior of the container.
  • the hose advantageously has a plurality of openings in the hose line. This ensures rapid delivery of the pharmaceutical dosage form into the interior of the container.
  • the hose can advantageously also have a non-return valve which prevents the pharmaceutical dosage form dispensed into the interior of the container from flowing back into the hose.
  • the connection provided for the connection with the application means can be provided in the interior of the container. NEN closure, so that leakage of the retained pharmaceutical dosage form in the application agent is excluded.
  • this can be a closed hose leading into the interior of the container.
  • the two hoses leading into the interior of the container can be connected to one another via a Y-connecting piece, the hose leading to the connection provided for the application means being tightly sealed or sealed by a pinch or weld .
  • the 3rd connection of the Y-connector has an open cap, through which the supplied pharmaceutical dosage form can flow into the blister.
  • the container according to the invention which causes the pharmaceutical dosage form to be transported through the container, advantageously has a continuous hose connection between the connections inside the container.
  • the container can be hollow or, if desired, can also be filled with suitable materials, such as absorbent materials and weight elements.
  • the container is preferably designed in accordance with the container which causes the pharmaceutical dosage form to be retained in the container.
  • the container according to the invention can furthermore have a venting device (e.g. valve) in order to compensate for pressure differences which result from the retention of the pharmaceutical dosage form in the container.
  • a venting device e.g. valve
  • the containers according to the invention are advantageously suitable for blinding the administration of non-solid, in particular liquid administration forms by intrapulmonary application.
  • Pharmaceutical dosage forms that have the properties of natural pulmonary surfactant may be mentioned as a liquid dosage form.
  • the dosage forms described in W095 / 32992 may be mentioned as examples.
  • the different containers are preferably designed in such a way that a differentiation by the person is not possible.
  • Fig. 1 is a schematic cross-sectional view of an embodiment of an opaque container according to the invention which retains the pharmaceutical dosage form in the container.
  • Fig. 2 is a schematic cross-sectional view of an embodiment of an opaque container according to the invention, which ensures the transport of the test substance through the container.
  • Fig. 3 shows a container according to the invention (hereinafter also referred to as a blind bag) in a "non flow type" configuration in a partially broken perspective view.
  • FIG. 4 shows a blind bag according to the invention in a "flow type" configuration in a representation according to FIG. 3.
  • FIG. 1 shows the embodiment of a container 1 according to the invention, which has a connection 2 suitable for connection with a dispensing means and a connection 3 suitable for connection with an application means.
  • the container 1 is filled with an absorbent material 4.
  • the container 1 has at the connection 2 a hose 5 leading into the interior of the container 1, which is open at its end 5 '.
  • the connection 3 also has a hose 6 leading into the interior of the container and closed at its end 6 '.
  • FIG. 2 shows the embodiment of a container 1 according to the invention, which has a connection 2 suitable for connection with a dispensing means and a connection 3 suitable for connection with an application means.
  • the connections 2 and 3 are connected in the interior of the container 1 with a continuous hose 5.
  • the container 1 is filled with an absorbent material 4.
  • a blind bag 10 according to the invention for example shown in FIG. 3, in a "non flow type" configuration has a film bag 11, formed from two film blanks 13, 14, preferably opaque, which are tightly connected to one another at the edges by means of welding, sealing or adhesive seams.
  • the film bag 11 has on its opposite narrow sides 15, 16 neck-like projections 17, 18, in which on the one hand a hose 19 for introducing a medium (for example test substance) and a venting device 20 and on the other hand an outlet hose 22 are sealed.
  • the venting device 20 is equipped with a conventional filter 21 for the germ-free venting of the inner region 23 of the blind bag 10.
  • the inlet hose 19 has at its free outer end 24 a so-called Luerlock connection element 25 in a "femal" design, which carries a cap-like connection adapter 26.
  • the end 27 of the inlet tube 19 on the inside of the bag is provided with a check valve 28 which prevents a backflow of a medium in the inlet tube 19.
  • the check valve 28 is connected to a 1st connection 29 of a Y-connector 32, which is connected with its 2nd connection 30 tightly to the outlet hose 22.
  • the outlet tube 22 has at its outer end 34 a so-called "male" Luer lock connection element 35 which can be connected to a tube system (not shown) which is suitably connected to, for example, a patient.
  • the outlet tube 22 is sealed within the blind bag 10 or sealed by a pinch or weld 22a.
  • One or more layers of an absorbent material 37 are provided in the interior 23 of the film bag 11 or blind bag 10, which is capable of absorbing and binding a defined amount of, for example, a medium.
  • an open cap 36 is provided, through which the medium entered via the inlet hose 19 flows into the interior 23 of the blind bag 10 and can be absorbed by the absorbent structure 37.
  • two weight elements 38 are advantageously provided in the interior of the blind bag 10, which obscure an accompanying weight gain.
  • An inventive blind bag 40 according to FIG. 4 in a "flow type” configuration basically has the same elements as the "non flow type” configuration according to FIG. 3, which is also characterized by the same meaning of the reference symbols used here.
  • the outlet tube 33 is designed to be open here, so that a medium can flow through the blind bag 40.
  • a closed cap 41 is provided on the third connection 31 of the Y-connector 32, i.e. no medium can penetrate into the interior 23 of the blind bag.
EP99971721A 1998-11-06 1999-11-05 Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques Expired - Lifetime EP1126888B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19851119 1998-11-06
DE19851119A DE19851119C2 (de) 1998-11-06 1998-11-06 Behälter und Vorrichtung zur Blindung der Verabreichung von nicht festen pharmazeutischen Darreichungsformen bei der klinischen Prüfung
PCT/EP1999/008476 WO2000027448A1 (fr) 1998-11-06 1999-11-05 Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques

Publications (2)

Publication Number Publication Date
EP1126888A1 true EP1126888A1 (fr) 2001-08-29
EP1126888B1 EP1126888B1 (fr) 2006-02-08

Family

ID=7886853

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99971721A Expired - Lifetime EP1126888B1 (fr) 1998-11-06 1999-11-05 Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques

Country Status (9)

Country Link
US (1) US6544250B1 (fr)
EP (1) EP1126888B1 (fr)
JP (1) JP2002529151A (fr)
AT (1) ATE317275T1 (fr)
AU (1) AU1380100A (fr)
CA (1) CA2350644C (fr)
DE (2) DE19851119C2 (fr)
ES (1) ES2258350T3 (fr)
WO (1) WO2000027448A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH696069A5 (de) * 2002-12-19 2006-12-15 Fisher Clinical Services Ag Behälter und dessen Verwendung in einer Verpackung, beispielsweise Heilmittelverpackung.
DE202004007115U1 (de) 2004-05-03 2004-07-08 Altana Pharma Ag Blindungsvorrichtung
US9833784B2 (en) * 2009-07-24 2017-12-05 Emd Millipore Corporation Feed bag construction
DK2804643T3 (en) * 2012-01-16 2018-03-05 Sanofi Aventis Deutschland BLINDING KIT FOR CLINICAL TRIALS
US9867567B2 (en) 2012-01-16 2018-01-16 Sanofi-Aventis Deutschland Gmbh Blinding kit for clinical trials

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE255260C (fr)
DD255260A (fr) *
US3572340A (en) * 1968-01-11 1971-03-23 Kendall & Co Suction drainage device
CH573026A5 (fr) * 1974-06-11 1976-02-27 Kaiser Josef Ag Fahrzeugwerk
CA1265963A (fr) * 1984-03-02 1990-02-20 George Joseph Duffy Dispositif d'injection
IT221762Z2 (it) * 1991-03-25 1994-10-20 Salvatore Sapienza Siringa opaca
KR100269731B1 (ko) * 1993-07-15 2000-10-16 하루타 히로시 영상 프로세서용 광원장치
IT1260685B (it) * 1993-09-29 1996-04-22 Sorin Biomedica Spa Dispositivo per il contenimento di sangue
DE4418936A1 (de) 1994-05-31 1996-02-08 Byk Gulden Lomberg Chem Fab Polypeptid
US5658248A (en) * 1995-08-04 1997-08-19 Localmed, Inc. Double-blind infusion device and method
US5980834A (en) * 1996-07-25 1999-11-09 The United States Of America As Represented By The Secretary Of Commerce Sample storage devices
US6287284B1 (en) * 1999-09-27 2001-09-11 Npt, Inc. Silicone bag assembly
US6569122B2 (en) * 2001-01-18 2003-05-27 Ultradent Products, Inc Syringe apparatus for delivering light activated materials

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0027448A1 *

Also Published As

Publication number Publication date
CA2350644C (fr) 2008-04-01
ATE317275T1 (de) 2006-02-15
CA2350644A1 (fr) 2000-05-18
DE19851119C2 (de) 2001-05-31
ES2258350T3 (es) 2006-08-16
DE59913117D1 (de) 2006-04-20
US6544250B1 (en) 2003-04-08
JP2002529151A (ja) 2002-09-10
AU1380100A (en) 2000-05-29
EP1126888B1 (fr) 2006-02-08
WO2000027448A1 (fr) 2000-05-18
DE19851119A1 (de) 2000-05-18

Similar Documents

Publication Publication Date Title
AT505615B1 (de) Medizinisches gerät in form eines katheters zum zu-, insbesondere jedoch abführen von fluid in, insbesondere aus körperhöhlen, insbesondere dem pleuraraum
DE2939881C2 (fr)
EP0757553B1 (fr) Distributeur fait d'une seule piece pour l'administration sans contamination de medicaments (cytostatiques)
EP0390898B1 (fr) Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange
DE2720470A1 (de) Kathetergeraet
DE1138186B (de) Infusionsgeraet zum Sammeln und Verabreichen von medizinischen Fluessigkeiten
CH691031A5 (de) Zweiteilige Vorrichtung für die Verabreichung von Arzneimitteln.
DE3716409A1 (de) Medizinische injektionsspritze
DE1087324B (de) Infusionsgeraet
EP3193970A1 (fr) Dispositif pour relier une bouteille perforée à un récipient ou à un conduit de fluide et pour transférer le contenu de la bouteille perforée dans un récipient ou un conduit de fluide, ainsi que procédé associé et utilisation d'un tel dispositif
DE2026086A1 (de) Bentelvorrichtung für Transfusion von Blut oder Flüssigkeiten
DE60116409T2 (de) Medizinische, vorgefertigte Einmalvorrichtung zum Verabreichen von mindestens zwei Medikamenten im vorgegebenen Verhältnis
DE4434114A1 (de) Verfahren und Vorrichtung zum Messen des Flußwiderstandes eines Katheters bei einem implantierten Infusionssystem für Arzneimittel
EP2537772A1 (fr) Dispositif de réception et de dépôt d'un fluide
DE69826495T2 (de) Medizinischer behälter
EP1126888B1 (fr) Dispositif pour realiser des essais aveugles dans le cadre d'essais cliniques
WO2020249738A2 (fr) Système de transfert de liquide et composants dédiés
DE4314090C2 (de) Medizinisches Besteck zur Herstellung einer Medikamentenlösung
EP2465557A1 (fr) Dispositif pour la sortie d'un liquide à partir d'un récipient
DE10028829A1 (de) Behältnis zum Aufbewahren, Vermischen und Verabreichen von Lösungen
EP3664860B1 (fr) Dispositif d'administration et procédé pour sa production
DE1066329B (de) Spritzampulle
DE8124084U1 (de) "ventil fuer ein infusions- oder punktionsgeraet"
DE102004021990B3 (de) Medizinischer Behälter zum Verabreichen einer Flüssigkeit aus einer Trägerlösung und einem zugemischten Medikament
DE4433669C2 (de) Einstückige Appliziervorrichtung zur kontaminationsfreien Verabreichung von in fester Ausgangsform vorliegenden Arzneimitteln, insbesondere Zytostatika

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20010606

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Free format text: AL PAYMENT 20010606;LT PAYMENT 20010606;LV PAYMENT 20010606;MK PAYMENT 20010606;RO PAYMENT 20010606;SI PAYMENT 20010606

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: ALTANA PHARMA AG

17Q First examination report despatched

Effective date: 20030611

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT;WARNING: LAPSES OF ITALIAN PATENTS WITH EFFECTIVE DATE BEFORE 2007 MAY HAVE OCCURRED AT ANY TIME BEFORE 2007. THE CORRECT EFFECTIVE DATE MAY BE DIFFERENT FROM THE ONE RECORDED.

Effective date: 20060208

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20060208

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

Free format text: NOT ENGLISH

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

Free format text: LANGUAGE OF EP DOCUMENT: GERMAN

REF Corresponds to:

Ref document number: 59913117

Country of ref document: DE

Date of ref document: 20060420

Kind code of ref document: P

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20060508

REG Reference to a national code

Ref country code: CH

Ref legal event code: NV

Representative=s name: E. BLUM & CO. PATENTANWAELTE

REG Reference to a national code

Ref country code: SE

Ref legal event code: TRGR

GBT Gb: translation of ep patent filed (gb section 77(6)(a)/1977)

Effective date: 20060517

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20060710

LTIE Lt: invalidation of european patent or patent extension

Effective date: 20060208

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2258350

Country of ref document: ES

Kind code of ref document: T3

ET Fr: translation filed
PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20061130

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20061109

REG Reference to a national code

Ref country code: CH

Ref legal event code: PFA

Owner name: NYCOMED GMBH

Free format text: ALTANA PHARMA AG#BYK-GULDEN-STRASSE 2#78467 KONSTANZ (DE) -TRANSFER TO- NYCOMED GMBH#BYK-GULDEN-STRASSE 2#78467 KONSTANZ (DE)

REG Reference to a national code

Ref country code: CH

Ref legal event code: PFA

Owner name: NYCOMED GMBH

Free format text: NYCOMED GMBH#BYK-GULDEN-STRASSE 2#78467 KONSTANZ (DE) -TRANSFER TO- NYCOMED GMBH#BYK-GULDEN-STRASSE 2#78467 KONSTANZ (DE)

NLT1 Nl: modifications of names registered in virtue of documents presented to the patent office pursuant to art. 16 a, paragraph 1

Owner name: NYCOMED GMBH

BECN Be: change of holder's name

Owner name: NYCOMED G.M.B.H.

Effective date: 20060208

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20060509

REG Reference to a national code

Ref country code: FR

Ref legal event code: CD

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20061105

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20060208

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: NL

Payment date: 20101110

Year of fee payment: 12

Ref country code: IE

Payment date: 20101110

Year of fee payment: 12

Ref country code: FR

Payment date: 20101123

Year of fee payment: 12

Ref country code: AT

Payment date: 20101110

Year of fee payment: 12

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20101104

Year of fee payment: 12

Ref country code: CH

Payment date: 20101112

Year of fee payment: 12

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20101103

Year of fee payment: 12

Ref country code: IT

Payment date: 20101113

Year of fee payment: 12

Ref country code: SE

Payment date: 20101111

Year of fee payment: 12

Ref country code: BE

Payment date: 20101117

Year of fee payment: 12

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20101217

Year of fee payment: 12

BERE Be: lapsed

Owner name: NYCOMED G.M.B.H.

Effective date: 20111130

REG Reference to a national code

Ref country code: NL

Ref legal event code: V1

Effective date: 20120601

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

REG Reference to a national code

Ref country code: SE

Ref legal event code: EUG

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20111105

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111130

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111130

Ref country code: NL

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20120601

REG Reference to a national code

Ref country code: FR

Ref legal event code: ST

Effective date: 20120731

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111105

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111130

REG Reference to a national code

Ref country code: DE

Ref legal event code: R119

Ref document number: 59913117

Country of ref document: DE

Effective date: 20120601

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111105

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111105

Ref country code: SE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111106

REG Reference to a national code

Ref country code: AT

Ref legal event code: MM01

Ref document number: 317275

Country of ref document: AT

Kind code of ref document: T

Effective date: 20111105

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: FR

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111130

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111105

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20120601

REG Reference to a national code

Ref country code: ES

Ref legal event code: FD2A

Effective date: 20131030

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: ES

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20111106