TW200812586A - Use of flibanserin for the treatment of post-menopausal sexual desire disorders - Google Patents
Use of flibanserin for the treatment of post-menopausal sexual desire disorders Download PDFInfo
- Publication number
- TW200812586A TW200812586A TW096116300A TW96116300A TW200812586A TW 200812586 A TW200812586 A TW 200812586A TW 096116300 A TW096116300 A TW 096116300A TW 96116300 A TW96116300 A TW 96116300A TW 200812586 A TW200812586 A TW 200812586A
- Authority
- TW
- Taiwan
- Prior art keywords
- menopause
- acquired
- sexual
- menstruation
- sexual desire
- Prior art date
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Classifications
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- 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
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
200812586 九、發明說明: 【發明所屬之技術領域】 本务月係關於弗利本西林(flibanserin)用於萝傷 療停經後性慾疾病的藥劑之用途。 …用以治 【發明内容】 化合物1-[2-(4-(3-三氟甲基-苯基)哌嗪基)乙基]2 3 :氫·1Η苯㈣H酮(弗利本©林)錢氯酸鹽形式=,3_ () 於歐洲專利申古杳宏"Ρ Ρ Δ < 1 /1。/1山 4 不 •号扪曱π案ΕΡ1526434中,且其具有以下化學结 構: 、、’口
弗利本西林對5-HTlj5_HT2_受體展示親和性。因此其
為用於治療例如抑鬱、精神***症及焦慮之各種病症之有 前景治'療劑。 專業術# I生疾病"包括性慾疾,病、性興奮障礙、性高潮 P章礙症、***疼痛症、歸因於一般醫學病狀之性功能障 礙物貝誘導型性功能障礙及未特定說明之性功能障礙 ⑼agnostic and Statistical Ma職】〇f Me·以·“,第 ^.Washington DCj American Psychiatric Association, 2000) 〇 本!x月係關於H兄作為游離驗、藥理學上可接受之酸 加成鹽形式及/或視情況作為其水合物及/或溶劑合物形式 118923.doc 200812586 之弗利本西林用於製 的用途。 ,、/σ療停經後女性性慾疾病之藥劑 在本發明中術*五丨丨、、Λ、戍^_ _ 等且右Π、Λ σ '、τ經後性慾減退(Hypoactive)疾病,丨 有療停經後女性性慾減退疾病”等之含義。 =㈣弗利本西林之有利作用,無論終身存在或後天 性:性㈣為,’-般類型”或”情境^^ 从病因起源(器官(身體與藥物誘發)、心理(歸因於心理 ° 為吕(身體與藥物誘發)與心理(歸因於心理因素)之 組合,或未知)。術語,,終身”係指本發明之該等性慾疾病自 性功能起始之曰起即存在。術語”後天性”係指本發明之該 等^疾病僅在—段正常性功能期間後發生。般類型” ,指本發明之該等性疾病不偶限於某些類型之刺激、情境 或伴侣。’’情境類型”適用於本發明之該等性疾病侷限於某 些類型之刺激、情境或伴侣。歸因於"心理目素,,之亞型適 用於判斷心理因素在性疾病之發作、嚴重程度、惡化或維 持中具有重要作用’且一般醫學狀況及物質在性疾病之病 因中無作用時。最後,歸因於,,組合因素,,之亞型適用於υ 判疋〜理因素在性疾病之發作、嚴重程度、惡化或維持中 具有作用;且2)亦判斷一般醫學狀況或所用物質可造成但 並不足以成為性疾病之理由時(Diagn〇stic and
Manual 〇f Mental Disorders,第 4 版,正文修訂本。
Washington DC,American Psychiatric Association,2000)。 因此,例如術語”終身停經後性慾減退疾病”係指自性功 能起始時起即存在之停經後女性性慾減退疾病,術語,,後 118923.doc 200812586 天性停經後性慾㈣疾病,,係指_段正 生之停經後女性性慾減退 $功能期間後發 乎存在明顯矛盾,但是其應理解=:辭'终身停… 病史顯示該疾病實際上自 起〜後所珍斷之疾病由 因此,在一個較佳實施:b起始之曰起即存在。 視情況呈# # — 1 ,本發明係關於弗利本西林 祝况壬游離鹼、樂理學 視情、兄呈k入仏 了接又之酸加成鹽形式及/或 ί、 視k况呈水合物及/或溶劑合物形式之 備-種供治療選自由以下組成之群的疾病之;系用^襄 經後性慾減退疾病、終身停經後性厭亞广/ 終身停 ***丧生处ό 更性厭惡疾病、終身停經後 心" 經後性慾缺乏、終身停經後性慾降低、 後性慾受抑、終身停經後性衝動⑽叫喪失、終 身停經歧衝料_isturbanee)及終身停經後性冷减。 根據本發明尤其較佳為視情況作為游離鹼'華理學上可 :受之酸加成鹽形式及/或視情況作為水合物及/或溶劑合 物形式之弗利本西林的用途,其係用於製備供治療選自由 以下各病症組成之群的疾病之藥劑:終身停經後性愁減退 疾病、終身停經後性厭惡疾病、終身停經後性慾喪失、終 身停經後性慾缺乏、終身停經後性慾降低及終身停經後性 慾受抑。 在-尤其較佳實施例中,本發明係關於視情況作為游離 藥理學上可接受之酸加成鹽形式及/或視情況作為水 0物及/或/合劑合物形式之弗利本西林之用途,其係用於 製備i、/CT療遥自以下病症之群的疾病之藥劑:終身停經後 性慾減退疾病、終身停經後性慾喪失及終身停經後性慾降 118923.doc 200812586 低0
在另+ —較佳實施例中,本發明係關於視情況作為游離 鹼藥理學上可接受之酸加成鹽形式及/或視情況作為水 ,物及/或溶劑合物形式之弗利本西林之用途,其係用於 製備供治療選自由以下各病症組成之群的疾病之藥劑:後 天經後性慾減退疾病、後天性停經後性厭惡疾病、後 天杜h經後㈣喪失、後天性停經後性慾缺乏、後天性停 經後性慾降低、後天性停經後性慾受抑、後天性停經後性 衝動喪失、後天性停經後性衝動干擾及後天性停經後性冷 —卜據本發明較佳為弗利本西林視情況呈游離驗、 樂理學上可接受之酸加 取I形式及/或視情況呈水合物及 或溶劑合物形式之用途,复 、 八係用於1備一種供治療選自由 乂下、、且成之群的疾症夕今丨 h 、广a 、条诏··後天性停經後性慾減退疾 病、後天性停經後性 、 後天性停經後***缺 交注心丧失 尸 心缺乏、後天性停經後性慾降低、後天性 停經後性慾受抑。 -俊天ί± 在一個特佳實施例中, 呈游離於i 务明係關於弗利本西林視情況 至游離鹼、樂理學上心 j接文之酸加成鹽形式及/. 呈水合物及/或_|_ 1 w/次則月況 Μ 、△说 物形式之用途,其係用於製備一鞴 供治療選自以下之蔴沾e + 表備種 r Λ 、浃;丙之藥劑··後天性停經後性芩減 低。 、、後随怒喪失及後天性停經後性慾降 此外, 本發明係關於一 般或情境亞型之任 一上述病狀及/ 118923.doc 200812586 或歸因於心理因素或歸因於組合因素者。
弗利本西林可視情況以游離鹼形式、醫藥學上可接受之 酸加成鹽形式及/或視情況以水合物及/或溶劑合物形式使 用。適當酸加成鹽包括例如選自以下之酸之加成鹽:丁二 酸、氫溴酸、乙酸、反丁烯二酸、順丁烯二酸、甲烷碏 S夂、礼酸、石粦酸、氫氣酸、硫酸、酒石酸及捧樣酸。亦可 使用上述酸加成鹽之混合物。上述酸加成鹽中,氫氯酸鹽 及氫演酸鹽,尤其氫氯酸鹽較佳。若弗利本西林以游離驗 形式使用,則其較佳以如wo 03/014079中所揭示之弗利本 西林多晶型物A之形式使用。 、弗利本西林’視情況以游離鹼、藥理學上可接受之酸加 成1形式及/或視情況以水合物及/或溶劑合物形式使用, 可併入固體、液體或噴霧劑形式之習知藥物製劑中。該组 合物可以例如適於口服、經直腸、非經腸投與或經鼻吸入 $形式提供,較佳形式包括例如踢囊、鍵劑、包衣錠劑、 女瓶瓶、栓劑及經鼻噴霧劑。 活性成份可倂人w㈣μ物^ :,該等賦形劑或載劑例如滑石、***夥、乳糖、; 洛一:了、玉米殿粉、水性或非水性媒劑、聚乙烯吼 二酸甘油酯、氯化苯甲煙錢、麟酸納、 聚山架醇酯80。將組合%古 :’各劑量單位經調適以供應單次劑量之活:::劑 ii8923.doc
-10- 200812586 各劑量單位可便利地含有〇.〇1叫至1〇〇 mg、較佳〇1至 50 mg。 每曰向患者投與1次、2次、3次或4次劑型。本發明之化 合物較佳每日投與三次或三次以下,更佳一或兩次,連續 一段時間。 、 η ϋ 較佳’在早晨及晚上向患者投與劑量,更佳早晨投與一 次(25或5〇 mg弗利本西林)且晚上一次(2s或5〇吨弗利本西 林)’最佳僅晚上一次(50或1〇〇 mg弗利本西林),連續—段 時間。為改良短時間可耐受性,可投與半數標乾劑量。 因此諸如鎮靜之副作用不顯著。 可藉由(例如)混合活性物質與已知賦形劑來獲得適當鍵 劑,該等已知賦形劑例如惰性稀釋劑,諸如碳酸詞、石:酸 約或乳糖;崩解劑,諸如玉㈣粉或褐 如澱粉或明膠;潤滑劑,諸如硬脂酸鎂或滑石及/或用以 延遲釋放之試劑,諸如羧甲美孅 、 ^ Τ基纖維素、對苯二甲酸醋酸纖 維素或聚乙酸乙烯酯。錠劑亦可包含若干層。 因此可藉由以例如可七_ γ ... Δ 、、 椚戈7力酮(C〇lhd〇ne)或蟲膠、*** 膝、滑石、一氧化鈦或糖之通當用於綠才|冷 、吊用於叙;^塗層之物質塗佈 類似於錠劑產生之核心來制供—十b W 1 、 木I備包衣錠劑。為實現延遲釋放 或預防不相容性’核心亦可由多層組成。類似地,旋劑涂 層可能使用上述錠劑賦形劑以多層組成從而實現 放。 根據本發明含有活性物皙夕她將斗、 初貝之糖漿或酏劑或其組合可另外 含有諸如糖精之甜味劑、p松| #缺碰 衣己胺基碩酸鹽、甘油或糖及例 118923.doc 11 · 200812586 如方香…堵如香草酸或燈提取物)之風 含有諸如幾甲基纖維素納之懸浮。其亦可 肪醇與氧化乙稀之縮合產物之濕潤劑==?如腊 酯之防腐劑。 一 、匕基苯甲酸 以例如添加諸如對_其贫田缺匕 仏基本甲酸酯之防腐劑或 四乙酸之鹼金屬鹽之雜宏為丨+ # 月女 蜀孤之%疋劑之常用方式製傷用 液,且將其轉移於注射小航或安瓶瓶中。 射之冷 可(例如)藉由將活性物質與諸如乳糖或山梨糖醇之惰性 載劑混合且將其封裝於明勝膠囊中來製備含有—或多種活 性物質或活性物質組合之膠囊。 >可(例如)藉由與為此目的而提供之諸如中性脂或聚乙二 醇或其衍生物之載劑相混合來製備適當栓劑。 [實施方式】 醫藥調配物之實例A) 以下實例在不限制本發明範疇之情況下說明本發明。 錠劑 每錠劑 弗利本西林 100 mg 乳糖 240 mg 玉米澱粉 340 mg 聚乙稀σ比哈唆酮 45 mg 硬脂酸鎂 15 mg 740 mg 將細粉狀活性物質、乳糖及一些玉米澱粉混合在一起 118923.doc -12· 200812586 η ο 濕 脂酸鎂篩分且混合在一起。 擠壓混合物 尺寸之錠劑。 Β) 錠劑 每鍵劑 弗利本西林 80 mg 玉米澱粉 190 mg 乳糖 55 mg 微晶纖維素 35 mg 聚乙稀°比略咬酉同 15 mg 羧甲基澱粉鈉 23 mg 硬脂酸鎂 2 ms 400 mg 將細粉狀活性物質、一些玉米殿粉、 及聚乙烯咄咯啶酮混合在一 起5將混合 米殿粉及水處理以形成顆粒 ,將其乾燥 基澱粉鈉及硬脂酸鎭且混合在一起,且 適當尺寸之錠劑。 C) 包衣旋劑 每包衣錠劑 弗利本西林 5 mg 玉米丨殿粉 41.5 mg 乳糖 30 mg 聚乙烯吼略π定g同 3 mg 硬脂酸鎂 0.5 ms 118923.doc ; 剩餘玉米殿粉及硬 -13 - 200812586 ο 80 mg 字 丨生物質、玉米殿粉、乳糖及聚乙稀d比略咬酮充分混 合且以水潤濕。使濕潤物質穿過具有1 孔尺寸之篩, 在約45 C下乾燥且隨後使顆粒穿過同一篩。混合入硬脂酸 美後在製錠機中擠壓具有6 mm直徑之凸錠劑核心。因此 產生2錠劑核心經已知方式塗佈有基本上由糖及滑石組成 之覆盖層。以蠟拋光成品包衣錠劑。
U D) 膠囊 每膠囊 弗利本西林 150 mg 玉米澱粉 268.5 mg 硬脂酸鎂 1.5 mg 420 mg 將物質及玉米殿粉混合且 以水潤濕。 乾燥。將乾燥顆粒篩分且與硬脂酸鎮混 裝填於1號硬質明膠膠囊中。 E) 安瓶瓶溶液 弗利本西林 50 mg 氯化鈉 50 mg 注射用水 5 ml 人 一 q π Γ执饥.丨月Λ隹pH 5 · 5至6.5下將活性物質淳 於水中’且添加氯㈣以使其等渗。過濾所得溶液使其 將成品混合, 含熱原質’且在無@條件下㈣液轉移於安飯瓶中,隨 將其殺菌且藉由溶合密封。 Ο 栓劑 118923.doc -14- 200812586 弗利本西林 50 mg 固體脂肪 1650 mg 1700 mg 勻分散。將 使硬脂熔化。在40°C下使經研磨活性物質 其冷卻至38°C且傾入稍微冷卻之栓劑模中。 €
118923.doc -15 -
Claims (1)
- 200812586 十、申請專利範圍: ι·-種㈣本西林(flibansedn)之用途,其視情況呈游離 鹼、樂理學上可接受之酸加成鹽形式及/或視情況呈水合 物及/或溶劑合物形式,其係用於製備供治療女性(终身 或後天性)停經後性慾疾病之藥劑。 η υ 2.如請求们之用途,其特徵在於該停經後性慾疾病係選 自由以下組成之群:終身停經後性慾減退(Hyp_tive)疾 病、、、身知經後性厭惡疾病、終身停經後性慾喪失、終 身停經後性慾缺乏、終身停經後性慾降低、終身停經後 性慈受抑、終身停經後性衝動(Hbid〇)喪失、終身停經後 性衝動干擾(disturbance)及終身停經後性冷感。 3.如請求項!或2之用途’其特徵在於該停經後性慾疾病係 ,自由以下組成之群:終身停經後性慾減退疾病、終身 停經後性厭惡疾病、終身停經後性慾喪失、終身停經後 性慾缺乏、終身停經後性懲降低、終身停經後性慾受 抑0 4.如請求们之用途,其特徵在於該停經後性慾疾病係選 自由以下組成之群:後天性停經後性慾減退疾病、後天 f生分經後性厭惡疾病、後天性停經後性慾喪失、後天性 停經後性慾缺乏、後天性停經後性慾降低、後天性停姐 後性慾受抑、後天性停經後性衝動喪失、後: 5· 性衝動干擾及後天性停經後性冷感。 、“ 如請求項1或4之用徐,i 4 + 選自由以下组成之群.後ΓΓ於該停經後性慾疾病係 ♦ •後天性停經後性慾減退疾病、後 118923.doc 200812586 天性停經後性厭惡 性停經後性慾缺乏 經後性慾受抑。 疾病、後天性停經後性慾喪失、後天 、後天性停經後性慾降低、後天性停 其特徵在於該停經 6.如請求項丨、2及4中任一項之用途 後性怒疾病為一般亞型。 r\ % β 8· 9. 如請求項1、2及4中任一項之用途 灸丨生二、疾病為情境(situational)亞型 如睛求項1、2及4中任一項之用途 後性怒疾病係歸因於心理因素。 ’其特徵在於該停經 〇 ’其特徵在於該停經 如請求項1、2及4中任一項之用途 後性怒疾病係歸因於組合因素。 其特徵在於該停經 10·如凊求項i、2及4中任一項之用途,其特徵在於弗利本 西林係以一種由選自下列酸所形成鹽之藥理學上可接受 之酸加成鹽形式使用:丁二酸、氫溴酸、乙酸、反丁烯一馱、順丁烯二酸、曱烷磺酸、乳酸、磷酸、氫氯酸、 硫酸、酒石酸、檸檬酸及其混合物。 U·如請求項卜2及4中任一項之用途,其特徵在於弗利本 西林係以游離鹼形式使用。 12·如:求項11之用途,其特徵在於弗利本西林係以游離鹼 之夕曰日型物A形式使用,該多晶型物A如使用Dsc量測具 有約161。(:之熔點。 、 I3·如請求項1、2及4中任一項之用途,其特徵在於弗利本 西林係以每天0·1至400 mg之劑量範圍使用。 14·如凊求項1、2及4中任一項之用途,其特徵在於弗利本 118923.doc 200812586 西林每天使用〆或兩次,連續一段時間。 15. 16. 如請求項i、2及4中任一項之用途,其特徵在於弗利本 西林在早晨及晚上使用,更佳早晨一次(25或5〇 mg弗利 本西林)及晚上一次(25或50 mg弗利本西林)。 月长員1、2及4中任一項之用途,其特徵在於弗利本 西林僅在晚μ μ 尤上使用一次(50或100 mg弗利本西林),連續 一段時間。 、 η118923.doc 200812586 七、指定代表圖: (一) 本案指定代表圖為:(無) (二) 本代表圖之元件符號簡單說明: / \ | f 八、本案若有化學式時,請揭示最能顯示發明特徵的化學式:ϋ 118923.doc
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2007
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- 2007-05-07 SI SI200731692T patent/SI2021006T1/sl unknown
- 2007-05-07 WO PCT/EP2007/054380 patent/WO2007128802A2/en active Application Filing
- 2007-05-07 CA CA002649938A patent/CA2649938A1/en not_active Abandoned
- 2007-05-07 PE PE2007000551A patent/PE20080090A1/es not_active Application Discontinuation
- 2007-05-07 DK DK07728833.0T patent/DK2021006T3/en active
- 2007-05-07 MX MX2008013827A patent/MX2008013827A/es not_active Application Discontinuation
- 2007-05-07 BR BRPI0712039-7A patent/BRPI0712039A2/pt not_active Application Discontinuation
- 2007-05-07 MY MYPI20084432 patent/MY151048A/en unknown
- 2007-05-07 PL PL07728833T patent/PL2021006T3/pl unknown
- 2007-05-07 PT PT77288330T patent/PT2021006E/pt unknown
- 2007-05-07 AU AU2007247094A patent/AU2007247094B2/en not_active Ceased
- 2007-05-07 RS RS20150713A patent/RS54398B1/en unknown
- 2007-05-07 HU HUE07728833A patent/HUE026156T2/en unknown
- 2007-05-07 ES ES07728833.0T patent/ES2551093T3/es active Active
- 2007-05-07 EP EP07728833.0A patent/EP2021006B1/en active Active
- 2007-05-07 EA EA200802208A patent/EA200802208A1/ru unknown
- 2007-05-07 KR KR1020087027420A patent/KR20090005371A/ko not_active Application Discontinuation
- 2007-05-07 JP JP2009508365A patent/JP2009536176A/ja active Pending
- 2007-05-08 CL CL2007001318A patent/CL2007001318A1/es unknown
- 2007-05-08 UY UY30333A patent/UY30333A1/es not_active Application Discontinuation
- 2007-05-08 US US11/745,515 patent/US20070265276A1/en not_active Abandoned
- 2007-05-08 TW TW096116300A patent/TW200812586A/zh unknown
- 2007-05-09 AR ARP070102001A patent/AR060880A1/es unknown
-
2008
- 2008-10-28 NO NO20084531A patent/NO20084531L/no not_active Application Discontinuation
- 2008-11-06 IL IL195135A patent/IL195135A0/en unknown
- 2008-11-07 EC EC2008008874A patent/ECSP088874A/es unknown
-
2012
- 2012-11-12 US US13/674,486 patent/US20130190326A1/en not_active Abandoned
-
2014
- 2014-06-24 US US14/313,291 patent/US20150051221A1/en not_active Abandoned
-
2015
- 2015-05-01 US US14/702,125 patent/US20150374683A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
PL2021006T3 (pl) | 2015-12-31 |
EA200802208A1 (ru) | 2009-04-28 |
WO2007128802A3 (en) | 2008-06-12 |
US20070265276A1 (en) | 2007-11-15 |
HUE026156T2 (en) | 2016-06-28 |
US20150374683A1 (en) | 2015-12-31 |
UY30333A1 (es) | 2008-01-02 |
AU2007247094A1 (en) | 2007-11-15 |
ECSP088874A (es) | 2008-12-30 |
AR060880A1 (es) | 2008-07-16 |
NO20084531L (no) | 2008-12-02 |
JP2009536176A (ja) | 2009-10-08 |
CL2007001318A1 (es) | 2008-01-18 |
PT2021006E (pt) | 2015-11-12 |
US20150051221A1 (en) | 2015-02-19 |
KR20090005371A (ko) | 2009-01-13 |
AU2007247094B2 (en) | 2012-11-01 |
RS54398B1 (en) | 2016-04-28 |
MY151048A (en) | 2014-03-31 |
US20130190326A1 (en) | 2013-07-25 |
SI2021006T1 (sl) | 2016-01-29 |
PE20080090A1 (es) | 2008-03-14 |
EP2021006B1 (en) | 2015-08-12 |
CA2649938A1 (en) | 2007-11-15 |
BRPI0712039A2 (pt) | 2011-12-20 |
DK2021006T3 (en) | 2015-11-23 |
MX2008013827A (es) | 2008-11-10 |
NZ573382A (en) | 2012-02-24 |
EP2021006A2 (en) | 2009-02-11 |
WO2007128802A2 (en) | 2007-11-15 |
ES2551093T3 (es) | 2015-11-16 |
IL195135A0 (en) | 2009-09-22 |
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