EP1622622A2 - Kombinationspräparat gegen schwindel - Google Patents
Kombinationspräparat gegen schwindelInfo
- Publication number
- EP1622622A2 EP1622622A2 EP04701888A EP04701888A EP1622622A2 EP 1622622 A2 EP1622622 A2 EP 1622622A2 EP 04701888 A EP04701888 A EP 04701888A EP 04701888 A EP04701888 A EP 04701888A EP 1622622 A2 EP1622622 A2 EP 1622622A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- combination
- dizziness
- vertigo
- study
- used according
- 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.)
- Ceased
Links
Classifications
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- 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
- A61P27/00—Drugs for disorders of the senses
-
- 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
Definitions
- the present invention relates to the use of cinnarizine and dimenhydrinate or their physiologically tolerable salts in combination.
- Dizziness is often described by the patient as if he is experiencing turning, swaying or lifting movements or the floor is swaying underfoot. Others describe the dizziness as a slight loss of consciousness with confusion and gait uncertainty.
- Three sensory systems are responsible for orienting people in space: the optical system, the vestibular system and the proprioceptive system.
- Dizziness is triggered by information conflicts of these three sensory systems, by lesions in peripheral or central equilibrium structures or by ocular or psychogenic disorders. Dizziness can also be an early sign of a serious illness. Dizziness can be caused by vascular diseases, cardiovascular diseases, metabolic diseases and rheology disorders. Because of this multitude of possible causes, an interdisciplinary diagnosis is required. The different vestibular forms of vertigo are usually classified according to their location. A distinction is made between peripheral-vestibular, central-vestibular and combined central / peripheral-vestibular vertigo.
- the differential diagnosis of vertigo is based above all on the comprehensive medical history.
- the medical history should include questions about the type of vertigo, accompanying vegetative disorders, vertigo-inducing situations or mechanisms, the duration of the vertigo attacks and underlying or concomitant illnesses.
- a standardized medical history sheet, in which the course of the disease can also be documented, can be helpful here.
- Tests to test the vestibulo-ocular system are based on the fact that the balance system responds to a labyrinthine stimulus with reflex eye movements (nystagmas).
- the patient's eye movements can be observed directly using the Frenzibrille or recorded using electronystagmography (ENG) or video oculography (VOG).
- the evaluable parameters here are the number of nystagn ⁇ rashes per unit of time (nystagmus frequency), the speed of the slow nystagmus phase (GLP, also: slow phase velocity, SPV) and the nystagmus amplitude.
- Standard procedures for irritation of the labyrinth are the calorific test with water or air, with which each labyrinth can be stimulated and checked individually, and swivel chair tests. If nystagmas already occur without a stimulus (i.e. there is a so-called spontaneous nystagmus), diagnostic conclusions can be drawn from the direction of the nystagmus beats.
- the Romberg standing test and the Unterberg pedaling test are particularly suitable for examining the vestibulo-spinal system.
- the patient's reactions can be observed directly and recorded using posturography or craniocorpography.
- the choice of the optimal drug therapy depends on the cause of the vertigo.
- the task is solved by using cinnarizine and dimenhydrinate in combination.
- the present invention therefore relates to the use of cinnarizine and dimenhydrinate or their physiologically tolerable salts in combination for the treatment of vertigo of any origin.
- Another object of the present invention is the use of cinnarizine and dimenhydrinate or their physiologically tolerable salts in combination for the manufacture of medicaments for the treatment of vertigo of any origin.
- the present invention furthermore relates to the use of cinnarizine and dimenhydrinate or their physiologically tolerable salts in combination in addition to pharmaceutically acceptable auxiliaries and / or additives for the manufacture of medicaments for the treatment of vertigo of any origin
- the invention thus solves the problem of successfully treating all forms of vertigo - in particular also the very frequently occurring forms of vertigo which cannot be clearly diagnosed - without successful therapeutic attempts. Due to the inventive use of the active ingredient combination of cinnarizine and dimenhydrinate, only a single medication is necessary. This represents a major advance in the treatment of vertigo.
- the individual active ingredients used in combination according to the invention are known per se.
- Cinnarizine (CAS 298-57-7) is the international free name (INN) for l-benzhydryl-4-trans-cinnamylpiperazine, is an antihistamine and vasodilator and is described, for example, in US Pat. No. 2,882,271.
- Dimenhydrinate (CAS 523-87-5) is the international free name (INN) for the 8-chlorothheophylline salt of diphenhydramine and is an antihistamine used as an antiemetic and against motion sickness and is described, for example, in US Pat. Nos. 2,499,058 or US-A -2, 534, 813. According to the invention, these active compounds can also be used in the form of their physiologically tolerable salts.
- Typical physiologically compatible inorganic and organic acids are, for example, hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid, oxalic acid, maleic acid, fu aric acid, lactic acid, tartaric acid, malic acid, citric acid, salicylic acid, adipic acid and benzoic acid.
- suitable acids are also theophylline and its derivatives, such as 8-chlorothheophylline, or other xanthines or caffeine and its derivatives.
- Other acids that can be used are described, for example, in Advances in Pharmaceutical Research, vol. 10, pages 224-225, Birkhäuser Verlag, Basel and Stuttgart, 1966, and Journal of Pharmaceutical Sciences, vol. 66, pages 1-5 (1977).
- the acid addition salts are generally in a manner known per se by mixing the free base or its solutions with the corresponding acid or its solutions in an organic solvent, for example a lower alcohol such as methanol, ethanol, n-propanol or isopropanol or a lower ketone such as Acetone, methyl ethyl ketone or methyl isobutyl ketone or an ether such as diethyl ether, tetrahydrofuran or dioxane. Mixtures of the solvents mentioned can also be used for better crystal deposition.
- physiologically compatible aqueous solutions of acid addition salts of the active ingredients of an aqueous acid solution used according to the invention can be prepared.
- the acid addition salts used according to the invention of the active ingredients can be in a conventional manner, for. B. with alkalis or ion exchangers, are converted into the free base.
- the free base can be Settling with inorganic or organic acids, especially those which are suitable for the formation of therapeutically usable salts, win further salts.
- These or other salts of the new compound, such as. B. the picrate can also be used to purify the free base by converting the free base into a salt, separating it and releasing the base from the salt.
- the present invention also relates to pharmaceuticals for oral, rectal, subcutaneous, intravenous or intramuscular application which, in addition to conventional carriers and diluents, contain a combination of the active compounds or their acid addition salt as active compound.
- the medicaments of the invention are produced in a known manner with the customary solid or liquid carriers or diluents and the commonly used pharmaceutical-technical auxiliaries in accordance with the desired type of application with a suitable dosage.
- the preferred preparations are in a dosage form which is suitable for oral administration. Dosage forms of this type are, for example, tablets, film-coated tablets, coated tablets, capsules, pills, powders, solutions or suspensions or depot forms.
- parenteral preparations such as injection solutions are also suitable. Suppositories may also be mentioned as preparations.
- Corresponding tablets can be obtained, for example, by mixing the active ingredient with known auxiliaries, for example inert diluents such as dextrose, sugar, sorbitol, mannitol, polyvinylpyrrolidone, disintegrants such as corn starch or alginic acid, binders such as starch or gelatin, lubricants such as magnesium stearate or talc and / or agents for achieving a depot effect such as carboxylpolymethylene, carboxylmethylcellulose, cellulose acetate phthalate or polyvinyl acetate.
- auxiliaries for example inert diluents such as dextrose, sugar, sorbitol, mannitol, polyvinylpyrrolidone, disintegrants such as corn starch or alginic acid, binders such as starch or gelatin, lubricants such as magnesium stearate or talc and / or agents for achieving a depot effect such as carboxy
- Coated tablets can accordingly be produced by coating cores produced analogously to the tablets with agents conventionally used in tablet coatings, for example polyvinylpyrrolidone or shellac, gum arabic, talc, titanium dioxide or sugar.
- the coated tablet can also consist of several layers, wherein the auxiliaries mentioned above for the tablets can be used.
- Solutions or suspensions with the active ingredient according to the invention can additionally taste-improving agents such as saccharin, cyclamate or sugar and z.
- B. contain flavorings such as vanillin or orange extract. They can also contain suspending agents such as sodium carboxymethylcellulose or preservatives such as p-hydroxybenzoates.
- Capsules containing active ingredients can be produced, for example, by mixing the active ingredient with an inert carrier such as milk sugar or sorbitol and encapsulating it in gelatin capsules.
- Suitable suppositories can be produced, for example, by mixing them with carriers such as neutral fats or polyethylene glycol or their derivatives.
- the use of the active ingredient combination according to the invention shows, among other things, the following surprising properties: • With the combination of active substances used according to the invention, the doctor can successfully treat a far larger spectrum of vertigo patients than with the individual substances (widening the therapeutic range, broadening the active profile). Cinnarizine as a single substance only has the indication "dizziness in diagnosed inner ear complaints, ie in peripheral vestibular complaints”.
- This study is a multicenter study in which the combination of active substances used according to the invention was compared with the individual components cinnarizine (50 mg) and dimenhydrinate (100 mg), which are usually highly dosed in monotherapy, and with placebo.
- Study centers were 3 ENT university clinics in Hungary (Budapest, Pecs, Debrecen). 246 patients were admitted who suffered from peripheral-vestibular, central-vestibular or the very common combined form of peripheral-central-vestibular dizziness.
- the combination of active substances used according to the invention proved to be statistically highly significant (p ⁇ 0.001) both compared to placebo and to the high-dose individual components.
- the active ingredient combination used according to the invention was statistically significantly superior (p ⁇ 0.01) to both individual components.
- Study IV (3 centers: ENT clinic at the University of Brunn, Neurological University Clinic Sofia, ENT clinic in Pilsen) also compared the active ingredient combination used according to the invention with the individual components in “original concentration” (20 mg cinnarizine or 40 mg dimenhydrinate) patients who suffered from either central-vestibular, peripheral-vestibular or combined peripheral-central-vestibular dizziness. This study also showed that the combination of active substances used according to the invention was statistically significantly superior (p ⁇ 0.01) to the individual components.
- Study VI was carried out in the ENT clinic, Pilsen. Patients with diagnosed inner ear vertigo were included.
- the reference substance in this case was betahistine. "The result showed a highly significant (p ⁇ 0.001) statistical superiority of the Active ingredient combination used according to the invention via the substance betahistine, which is the standard for this indication.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Hospice & Palliative Care (AREA)
- Otolaryngology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09177748A EP2174690A1 (de) | 2003-01-15 | 2004-01-14 | Kombinationspräparat mit Cinnarizin und Dimenhydrinat zur Behandlung von Schwindel |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10301981A DE10301981A1 (de) | 2003-01-15 | 2003-01-15 | Kombinationspräparat gegen Schwindel |
PCT/DE2004/000072 WO2004064843A2 (de) | 2003-01-15 | 2004-01-14 | Kombination zur behandlung von schwindel, welche cinnarizin und dimenhydrinat enthält |
Publications (1)
Publication Number | Publication Date |
---|---|
EP1622622A2 true EP1622622A2 (de) | 2006-02-08 |
Family
ID=32602769
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP04701888A Ceased EP1622622A2 (de) | 2003-01-15 | 2004-01-14 | Kombinationspräparat gegen schwindel |
EP09177748A Ceased EP2174690A1 (de) | 2003-01-15 | 2004-01-14 | Kombinationspräparat mit Cinnarizin und Dimenhydrinat zur Behandlung von Schwindel |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP09177748A Ceased EP2174690A1 (de) | 2003-01-15 | 2004-01-14 | Kombinationspräparat mit Cinnarizin und Dimenhydrinat zur Behandlung von Schwindel |
Country Status (11)
Country | Link |
---|---|
US (3) | US20060135533A1 (de) |
EP (2) | EP1622622A2 (de) |
JP (2) | JP2006515610A (de) |
KR (1) | KR20050092106A (de) |
CN (1) | CN1738626A (de) |
BR (1) | BRPI0406746A (de) |
CA (1) | CA2511948A1 (de) |
DE (1) | DE10301981A1 (de) |
PL (1) | PL378180A1 (de) |
RU (1) | RU2005125062A (de) |
WO (1) | WO2004064843A2 (de) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10301981A1 (de) * | 2003-01-15 | 2004-07-29 | Hennig Arzneimittel Gmbh & Co. Kg | Kombinationspräparat gegen Schwindel |
DE102005014141B4 (de) * | 2005-03-23 | 2006-12-21 | Hennig Arzneimittel Gmbh & Co. Kg | Tablettenförmige Retardzubereitung gegen Schwindel |
DE102005014142B4 (de) * | 2005-03-23 | 2006-11-09 | Hennig Arzneimittel Gmbh & Co. Kg | Pelletförmige Retardzubereitung gegen Schwindel |
WO2011024029A1 (en) * | 2009-08-24 | 2011-03-03 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Fast disintegrating dosage forms of cinnarizine and dimenhydrinate combination |
CN109170773A (zh) * | 2018-10-09 | 2019-01-11 | 河南科技大学 | 一种宇航员用防眩晕功能食品的制备方法 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2499058A (en) | 1950-02-28 | B-haloxantfflne salts of diarylalkyl | ||
US2882271A (en) | 1959-04-14 | Xcixcxh | ||
US2534813A (en) | 1950-01-21 | 1950-12-19 | Searle & Co | 8-haloxanthine salts of cyclic-aminoalkyl benzohydryl ethers and the production thereof |
US4792452A (en) * | 1987-07-28 | 1988-12-20 | E. R. Squibb & Sons, Inc. | Controlled release formulation |
DE10301981A1 (de) * | 2003-01-15 | 2004-07-29 | Hennig Arzneimittel Gmbh & Co. Kg | Kombinationspräparat gegen Schwindel |
DE102005014141B4 (de) * | 2005-03-23 | 2006-12-21 | Hennig Arzneimittel Gmbh & Co. Kg | Tablettenförmige Retardzubereitung gegen Schwindel |
DE102005014142B4 (de) * | 2005-03-23 | 2006-11-09 | Hennig Arzneimittel Gmbh & Co. Kg | Pelletförmige Retardzubereitung gegen Schwindel |
-
2003
- 2003-01-15 DE DE10301981A patent/DE10301981A1/de not_active Withdrawn
-
2004
- 2004-01-14 RU RU2005125062/15A patent/RU2005125062A/ru unknown
- 2004-01-14 CA CA002511948A patent/CA2511948A1/en not_active Abandoned
- 2004-01-14 CN CNA2004800022452A patent/CN1738626A/zh active Pending
- 2004-01-14 EP EP04701888A patent/EP1622622A2/de not_active Ceased
- 2004-01-14 PL PL378180A patent/PL378180A1/pl not_active Application Discontinuation
- 2004-01-14 WO PCT/DE2004/000072 patent/WO2004064843A2/de active Application Filing
- 2004-01-14 BR BR0406746-0A patent/BRPI0406746A/pt not_active Application Discontinuation
- 2004-01-14 JP JP2006500474A patent/JP2006515610A/ja active Pending
- 2004-01-14 EP EP09177748A patent/EP2174690A1/de not_active Ceased
- 2004-01-14 KR KR1020057012785A patent/KR20050092106A/ko not_active Application Discontinuation
- 2004-01-14 US US10/542,279 patent/US20060135533A1/en not_active Abandoned
-
2009
- 2009-01-21 US US12/321,496 patent/US20090137602A1/en not_active Abandoned
-
2011
- 2011-03-02 JP JP2011044923A patent/JP2011140502A/ja not_active Ceased
-
2012
- 2012-02-27 US US13/405,427 patent/US20120157475A1/en not_active Abandoned
Non-Patent Citations (1)
Title |
---|
See references of WO2004064843A2 * |
Also Published As
Publication number | Publication date |
---|---|
US20120157475A1 (en) | 2012-06-21 |
KR20050092106A (ko) | 2005-09-20 |
CA2511948A1 (en) | 2004-08-05 |
WO2004064843A3 (de) | 2004-12-23 |
US20060135533A1 (en) | 2006-06-22 |
US20090137602A1 (en) | 2009-05-28 |
PL378180A1 (pl) | 2006-03-06 |
JP2011140502A (ja) | 2011-07-21 |
EP2174690A1 (de) | 2010-04-14 |
BRPI0406746A (pt) | 2005-12-20 |
CN1738626A (zh) | 2006-02-22 |
DE10301981A1 (de) | 2004-07-29 |
RU2005125062A (ru) | 2006-01-27 |
JP2006515610A (ja) | 2006-06-01 |
WO2004064843A2 (de) | 2004-08-05 |
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