Extract from the Register of European Patents

About this file: EP2266573

EP2266573 - Fulvestrant formulation [Right-click to bookmark this link]
StatusThe patent has been granted
Status updated on  19.07.2017
Database last updated on 15.12.2018
Most recent event   Tooltip16.05.2018Change: Date of oral proceedings 
Applicant(s)For all designated states
AstraZeneca AB
151 85 Södertälje / SE
[2015/25]
Former [2010/52]For all designated states
AstraZeneca AB
151 85 Södertälje / SE
Inventor(s)01 / Evans, John
AstraZeneca R&D Alderley
Alderley Park
Macclesfield, Cheshire SK10 4TG / GB
02 / Grundy, Rosalind Ursula
AstraZeneca R&D Alderley
Alderley Park
Macclesfield, Cheshire SK10 4TG / GB
 [2015/25]
Former [2010/52]01 / Evans, John
AstraZeneca R&D Alderley Alderley Park
Macclesfield, Cheshire SK10 4TG / GB
02 / Grundy, Rosalind Ursula
AstraZeneca R&D Alderley Alderley Park
Macclesfield, Cheshire SK10 4TG / GB
Representative(s)Hoffmann Eitle
Patent- und Rechtsanwälte PartmbB
Arabellastraße 30
81925 München / DE
[2015/25]
Former [2014/01]HOFFMANN EITLE
Patent- und Rechtsanwälte
Arabellastrasse 4
81925 München / DE
Former [2010/52]Giles, Allen Frank , et al
AstraZeneca AB, Global Intellectual Property
151 85 Södertälje / SE
Application number, filing date10180667.708.01.2001
[2010/52]
Priority number, dateGB2000000031310.01.2000         Original published format: GB 0000313
GB2000000883712.04.2000         Original published format: GB 0008837
[2010/52]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP2266573
Date:29.12.2010
Language:EN
[2010/52]
Type: B1 Patent specification 
No.:EP2266573
Date:17.06.2015
Language:EN
[2015/25]
Search report(s)(Supplementary) European search report - dispatched on:EP23.11.2010
ClassificationInternational:A61K31/565, A61P35/00, A61K47/14, A61K47/44, A61K9/08
[2010/52]
Designated contracting statesAT,   BE,   CH,   CY,   DE,   DK,   ES,   FI,   FR,   GB,   GR,   IE,   IT,   LI,   LU,   MC,   NL,   PT,   SE,   TR [2015/25]
Former [2010/52]AT,  BE,  CH,  CY,  DE,  DK,  ES,  FI,  FR,  GB,  GR,  IE,  IT,  LI,  LU,  MC,  NL,  PT,  SE,  TR 
Extension statesAL29.06.2011
LT29.06.2011
LV29.06.2011
MK29.06.2011
RO29.06.2011
SI29.06.2011
TitleGerman:Fulvestrant Formulierung[2010/52]
English:Fulvestrant formulation[2010/52]
French:Formulation de fulvestrant[2010/52]
Examination procedure28.09.2010Examination requested  [2010/52]
17.12.2010Despatch of a communication from the examining division (Time limit: M06)
11.10.2011Reply to a communication from the examining division
14.12.2011Observations by third parties
01.03.2013Despatch of a communication from the examining division (Time limit: M06)
07.10.2013Despatch of communication that the application is deemed to be withdrawn, reason: reply to the communication from the examining division not received in time
13.12.2013Reply to a communication from the examining division
25.03.2014Despatch of a communication from the examining division (Time limit: M04)
21.07.2014Reply to a communication from the examining division
18.11.2014Communication of intention to grant the patent
01.12.2014Observations by third parties
23.12.2014Fee for grant paid
23.12.2014Fee for publishing/printing paid
23.12.2014Receipt of the translation of the claim(s)
16.04.2015Observations by third parties
Parent application(s)   TooltipEP01900186.6  / EP1250138
EP05016921.8  / EP1669073
Divisional application(s)The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued (EP20010900186) is  03.05.2005
Opposition(s)Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 02  16.02.2016  19.02.2016  ADMISSIBLE
Actavis Group PTC ehf
Reykjavikurvegur 76-78
222 Hafnarfjordur / IS
Opponent's representative
Best, Michael
Lederer & Keller
Patentanwälte Partnerschaft mbB
Unsöldstrasse 2
80538 München / DE
 03  08.03.2016  16.03.2016  ADMISSIBLE
Fresenius Kabi Deutschland GmbH
Else-Kröner-Str. 1
61352 Bad Homburg / DE
Opponent's representative
Fresenius Kabi Deutschland GmbH
Patent Department
Borkenberg 14
61440 Oberursel / DE
 04  17.03.2016  22.03.2016  ADMISSIBLE
Intas Pharmaceuticals Ltd.
2nd Floor Chinubhai Centre
Ashram Road
Ahmedabad 380009
GUJ / IN
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 05  16.03.2016  29.03.2016  ADMISSIBLE
Teva Pharmaceutical Industries Ltd.
5 Basel Street
Petach Tikva 49131 / IL
Opponent's representative
Best, Michael
Lederer & Keller
Patentanwälte Partnerschaft mbB
Unsöldstrasse 2
80538 München / DE
 [2016/51]
Former [2016/17]
Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 02  16.02.2016  19.02.2016  ADMISSIBLE
Actavis Group PTC ehf
Reykjavikurvegur 76-78
222 Hafnarfjordur / IS
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
 03  08.03.2016  16.03.2016  ADMISSIBLE
Fresenius Kabi Deutschland GmbH
Else-Kröner-Str. 1
61352 Bad Homburg / DE
Opponent's representative
Fresenius Kabi Deutschland GmbH
Patent Department
Borkenberg 14
61440 Oberursel / DE
 04  17.03.2016  22.03.2016  ADMISSIBLE
Intas Pharmaceuticals Ltd.
2nd Floor Chinubhai Centre
Ashram Road
Ahmedabad 380009
GUJ / IN
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
 05  16.03.2016   
Teva Pharmaceutical Industries Ltd.
5 Basel Street
Petach Tikva 49131 / IL
Opponent's representative
Best, Michael
Lederer & Keller
Patentanwälte Partnerschaft mbB
Unsöldstrasse 2
80538 München / DE
Former [2016/16]
Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 02  16.02.2016  19.02.2016  ADMISSIBLE
Actavis Group PTC ehf
Reykjavikurvegur 76-78
222 Hafnarfjordur / IS
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
 03  08.03.2016  16.03.2016  ADMISSIBLE
Fresenius Kabi Deutschland GmbH
Else-Kröner-Str. 1
61352 Bad Homburg / DE
Opponent's representative
Fresenius Kabi Deutschland GmbH
Patent Department
Borkenberg 14
61440 Oberursel / DE
 04  17.03.2016   
Intas Pharmaceuticals Ltd.
2nd Floor Chinubhai Centre
Ashram Road
Ahmedabad 380009
GUJ / IN
Opponent's representative
Ter Meer Steinmeister & Partner
Patentanwälte mbB
Nymphenburger Straße 4
80335 München / DE
Former [2016/15]
Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 02  16.02.2016  19.02.2016  ADMISSIBLE
Actavis Group PTC ehf
Reykjavikurvegur 76-78
222 Hafnarfjordur / IS
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
 03  08.03.2016   
Fresenius Kabi Deutschland GmbH
Else-Kröner-Str. 1
61352 Bad Homburg / DE
Opponent's representative
Fresenius Kabi Deutschland GmbH
Patent Department
Borkenberg 14
61440 Oberursel / DE
Former [2016/12]
Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
 02  16.02.2016   
Actavis Group PTC ehf
Reykjavikurvegur 76-78
222 Hafnarfjordur / IS
Opponent's representative
Cooke, Richard Spencer
Elkington and Fife LLP
Patents Department
3-4 Holborn Circus
London EC1N 2HA / GB
Former [2015/50]
Opponent(s)01  29.10.2015  03.11.2015  ADMISSIBLE
Hexal AG
Industriestrasse 25
83607 Holzkirchen / DE
Opponent's representative
Greiner, Elisabeth
df-mp Dörries Frank-Molnia & Pohlman
Patentanwälte Rechtsanwälte PartG mbB
Theatinerstraße 16
80333 München / DE
28.04.2016Invitation to proprietor to file observations on the notice of opposition
08.09.2016Reply of patent proprietor to notice(s) of opposition
08.05.2017Date of oral proceedings
20.07.2017Despatch of minutes of oral proceedings
20.07.2017Despatch of communication that the patent will be revoked
Appeal following opposition12.07.2017Appeal received No.  T1680/17
28.11.2017Statement of grounds filed
23.01.2019Date of oral proceedings
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the examination report
13.12.2013Request for further processing filed
13.12.2013Full payment received (date of receipt of payment)
Request granted
02.01.2014Decision despatched
The application is deemed to be withdrawn due to failure to reply to the examination report
11.10.2011Request for further processing filed
11.10.2011Full payment received (date of receipt of payment)
Request granted
20.10.2011Decision despatched
Fees paidRenewal fee
28.01.2011Renewal fee patent year 03
28.01.2011Renewal fee patent year 04
28.01.2011Renewal fee patent year 05
28.01.2011Renewal fee patent year 06
28.01.2011Renewal fee patent year 07
28.01.2011Renewal fee patent year 08
28.01.2011Renewal fee patent year 09
28.01.2011Renewal fee patent year 10
31.01.2011Renewal fee patent year 11
31.01.2012Renewal fee patent year 12
31.01.2013Renewal fee patent year 13
31.01.2014Renewal fee patent year 14
02.02.2015Renewal fee patent year 15
Lapses during opposition  TooltipMC31.01.2017
[2017/47]
Documents cited:Search[Y]EP0346014  (ICI PLC [GB]) [Y] 1-15 * page 9; example 3 *;
 [A]WO9619997  (SCHERING AG [DE]) [A] 1-15 * claims 1,5,6,8 * * page 16; example 5 *;
 [A]WO9721440  (ZENECA LTD [GB], et al) [A] 1-15 * claims 1,6 * * examples 1,3,4 *;
 [A]EP0310542  (SCHERING AG [DE]) [A] 1-15 * claim 8 *;
 [A]US4388307  (CAVANAK THOMAS [CH]) [A] 1-15 * examples 2-5 * * column 5, line 5 - line 37 *
 [Y]  - RIFFKIN C ET AL, "CASTOR OIL AS A VEHICLE FOR PARENTERAL ADMINISTRATION OF STEROID HORMONES.", JOURNAL OF PHARMACEUTICAL SCIENCES AUG 1964, (196408), vol. 53, ISSN 0022-3549, pages 891 - 895, XP009094139 [Y] 1-15 * page 892, column 1, paragraph LAST * * tables 5,6 *

DOI:   http://dx.doi.org/10.1002/jps.2600530809
 [A]  - JOHN C. WATERTON; ET AL., "A Case of Adenomyosis in a Pigtailed Monkey Diagnosed by Magnetic Resonance Imaging and treated with the Novel Pure Antiestrogen, ICI 182,780", LABORATORY ANIMAL SCIENCE, (1993), vol. 43, no. 3, pages 247 - 251, XP000998289 [A] 1-15 * page 247, column 2, paragraph 2 *
ExaminationUS3164520
    - ROBERTSON J F R ET AL, "Fulvestrant: pharmacokinetics and pharmacology.", BRITISH JOURNAL OF CANCER MAR 2004, (200403), vol. 90 Suppl 1, ISSN 0007-0920, pages S7 - 10
    - MCLESKEY S W ET AL, "Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in vivo to the antiestrogen ICI 182,780 and two aromatase inhibitors.", CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH MAR 1998, (199803), vol. 4, no. 3, ISSN 1078-0432, pages 697 - 711
    - HOWELL A ET AL, "PHARMACOKINETICS, PHARMACOLOGICAL AND ANTI-TUMOUR EFFECTS OF THE SPECIFIC ANTI-OESTROGEN ICI 182780 IN WOMEN WITH ADVANCED BREAST CANCER", BRITISH JOURNAL OF CANCER, NATURE PUBLISHING GROUP, GB, (19960101), vol. 74, no. 2, ISSN 0007-0920, pages 300 - 308, XP001007967
by applicantEP0138504
 US5183814
    - RIFFKIN, J. PHARM. SCI., (1964), vol. 53, page 891
    - MARTINDALE:, The Extra Pharmacopoeia 32nd edition, page 1103
    - BOWLER J; LILLEY TJ; PITTAM JD; WAKELING AE, "Novel steroidal pure antioestrogens", STEROIDS, vol. 989, pages 5471 - 99
    - WAKELING AE, "Novel pure antioestrogens: mode of action and therapeutic prospects", AMERICAN NEW YORK ACADEMY SCIENCE, (1990), vol. 595, pages 348 - 56
    - "Steroidal pure antioestrogens", WAKELING AE, Regulatory mechanisms in breast cancer, KLUWER ACADEMIC, (1990), pages 239 - 57
    - WAKELING AE, "Therapeutic potential of pure antioestrogens in the treatment of breast cancer", JOURNAL STEROID BIOCHEMISTRY, (1990), vol. 37, pages 771 - 5
    - WAKELING AE; BOWLER J, "Steroidal pure antioestrogens", JOURNAL ENDOCRINOLOGY, (1987), vol. 112, pages R7 - 10
    - WAKELING AE; BOWLER J, "Biology and mode of action of pure antioestrogens", JOURNAL STEROID BIOCHEMISTRY, (1988), vol. 3, pages 141 - 7
other   - MCLESKEY S.W. ET AL, "Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in Vivo to the antiestrogen ICI 182,780 and two aromatase inhibitors", CLINICAL CANCER RESEARCH, (199803), vol. 4, pages 697 - 711, XP003028538
    - "SAFE HANDLING PRACTICES OF INDUSTRIAL SCALE GRIGNARD REAGENTS", RAKITA E., HANDBOOK OF GRIGNARD REAGENTS, (1996), pages 79 - 87, ISBN 978-0-8247-9545-0, XP003035626

DOI:   http://dx.doi.org/10.1201/b16932-6
    - HOWELL A. ET AL, "PHARMACOKINETICS, PHARMACOLOGICAL AND ANTI-TUMOUR EFFECTS OF THE SPECIFIC ANTI-OESTROGEN ICI 182780 IN WOMEN WITH ADVANCED BREAST CANCER", BRITISH JOURNAL OF CANCER, (199607), vol. 74, pages 300 - 308, XP001007967
OppositionEP0346014
 EP1250138
 EP1250138
    - MCLESKEY et al., "Tamoxifen-resistant Fibroblast Growth Factor-transfected MCF-7 Cells Are Cross-Resistant in Vivo to the Antiestrogen |C| 182,780 and Two Aromatase Inhibitors.", Clinical Cancer Research, (19980300), vol. 4, pages 697 - 711, XP003028538
    - WAYNFORTH et al., "Good Practice Guidelines - Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit).", LASA, (19981000), pages 1 - 4, XP055283815
    - HOWELL A et al., "Pharmacokinetics, pharmacological and anti-tumour effects of the specific anti-oestrogen |C| 182780 in women with advanced breast cancer.", British Journal of Cancer, (19960000), vol. 74, no. 2, pages 300 - 308, XP001007967
    - HOWELL et al., "Response to a specific antioestrogen (|C| 182780) in tamoxifen-resistant breast cancer.", The Lancet, (19950107), vol. 345, no. 8941, pages 29 - 30, XP009004877

DOI:   http://dx.doi.org/10.1016/S0140-6736(95)91156-1
    - SUCKER et al., "Beschreibung der Arzneiformen", Pharmazeutische Technologie., Stuttgart, page 612, XP055237722
    - RIFFKIN C et al., "Castor Oil as a Vehicle for Parenteral Administration of Steroid Hormones.", Journal of Pharmaceutical Sciences, (19640800), vol. 53, no. 8, pages 891 - 895, XP009094139

DOI:   http://dx.doi.org/10.1002/jps.2600530809
    - O'REGAN et al., "Effects of the Antiestrogens Tamoxifen, Toremifene, and ICI 182,780", Endometrial Cancer Growth JNCI J Natl Cancer Inst, (19981021), vol. 90, no. 20, pages 1552 - 1558, XP055237729
    - D G Chapman, "Parenteral products", D G Chapman, WINFIELD et al., Pharmaceutical Practice, Churchill Livingstone, (19980101), XP055283826
    - S. W. MCLESKEY et al., "Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in Vivo to the antiestrogen ICI 182,780 and two aromatase inhibitors", Clinical Cancer Research, (19980300), vol. 4, pages 697 - 711, XP003028538
    - "Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit", GOOD PRACTICE GUIDELINES, (19981000), XP055283815
    - A. HOWELL et al., "Pharmacokinetics, pharmacological and anti-tumor effects of the specific anti-oestrogen ICI 182780 in women with advanced breast cancer", British Journal of Cancer, (19960000), vol. 74, pages 300 - 308, XP001007967
    - HOWELL et al., "Response to a specific antioestrogen (ICI 182780) in tamofixen-resistant breast cancer", Lancet, (19950000), vol. 345, pages 29 - 30, XP009004877

DOI:   http://dx.doi.org/10.1016/S0140-6736(95)91156-1
    - H. SUCKER et al., Pharmazeutische Technologie, (19780000), page 612, XP055237722
    - PFEIFER et al., Biopharmazie, page 59, XP055237725
    - RIFFKIN et al., "Castor Oil as a vehicle for parenteral administration of steroid hormones", J. Pharm. Sci, (19640000), pages 891 - 895, XP009094139

DOI:   http://dx.doi.org/10.1002/jps.2600530809
    - R. M. O'REAGAN et al., "Effects of the Antiestrogens Tamoxifen, Toremifene, and ICI 182,780 on Endometrial Cancer Growth", J. Nat. Cancer Inst., (19980000), vol. 90, pages 1552 - 1558, XP055237729
    - HOWELL et al., "Breast cancer trials with Faslodex", A new class of antiestrogen, (19980000), vol. 34, no. 5, page S19, XP022691381

DOI:   http://dx.doi.org/10.1016/S0959-8049(98)80072-5
    - DEFRIEND et al., "Investigation of a new pure antiestrogen (ICI 182780) in women with primary breast cancer", Cancer Res., (19940115), vol. 54, no. 2, pages 408 - 414, XP001122348
    - "Benzyl benzoate and ethyl alcohol", Handbook of Pharmaceutical Excipients, pages 7 - 9,38-39, XP055284211
    - MCLESKEY et al., "Tamoxifen-resistant fibroblast growth factor-transfected MCF-7 cells are cross-resistant in Vivo to the antiestrogen ICI 182,780 and two aromatase inhibitors", Clinical Cancer Res, (19980000), vol. 4, pages 697 - 711, XP003028538
    - LABORATORY ANIMAL SCIENCE ASSOCIATION, "Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit", GOOD PRACTICE GUIDELINES, (19981000), XP055283815
    - HOWELL et al., "Pharmacokinetics, pharmacological and anti-tumor effects of the specific anti- oestrogen ICI 182780 in women with advanced breast cancer", British Journal of Cancer, (19960000), vol. 74, no. 2, pages 300 - 308, XP001007967
    - HOWELL et al., "Response to a specific antioestrogen (ICI 182780) in tamoxifen-resistant breast cancer", Lancet, (19950107), vol. 345, no. 8941, pages 29 - 30, XP009004877

DOI:   http://dx.doi.org/10.1016/S0140-6736(95)91156-1
    - "Beschreibung der Arzneiformen", Pharmazeutische Technologie, Stuttgart, Thieme Verlag, page 612, XP055237722
    - "Biopharmazie", 4.2.9. Subkutane und intramuskuläre Absorption, Ullstein Mosby, (19840000), page 59, XP055237725
    - RIFFKIN et al., "Castor Oil as a vehicle for parenteral administration of steroid hormones", J. Pharm. Sd, (19641200), pages 891 - 895, XP009094139

DOI:   http://dx.doi.org/10.1002/jps.2600530809
    - O'REGAN et al., "Effects of the Antiestrogens Tamoxifen, Toremifene, and ICI 182,780 on Endometrial Cancer Growth", Journal of National Cancer Institute, (19981021), vol. 90, no. 20, pages 1552 - 1558, XP055237729
    - HOWELL et al., "Breast cancer trials with Faslodex - A new class of antioestrogen", European Journal of Cancer, (19980000), vol. 34, no. 5, page S19, XP022691381

DOI:   http://dx.doi.org/10.1016/S0959-8049(98)80072-5
    - Anonymous, "Zeneca Allays Fears Of Near-Term Product Gap", the Pharma Letter, URL: http://www.thepharmaletter.com/article/zeneca-allays-fears-of-near-term-product-gap, XP055327257
    - The Pink Sheet, "ZENECA FASLODEX PHASE III TRIAL v. TAMOXIFEN TO START IN EARLY 1998, WITH APPROVAL TARGET IN 2001; CASODEX EARLY PROSTATE CANCER TRIAL IS 80% ENROLLED", (19971208), URL: https://pink.pharmamedtechbi.com/PS031267/ZENECA-FASLODEX-PHASE-III-TRIAL-v-TAMOXIFEN-TO-START-IN-EARLY-1998-WITH-APPROVAL-TARGET- IN-2001-CASODEX-EARLY-PROSTATE-CANCER-TRIAL-IS-80-ENROLLED, XP055327263
    - Heinz Sucker, Peter Fuchs, Peter Speiser, Pharmazeutische Technologie, Georg Thieme, (19780000), pages 1pp, 551 - 553, XP055327273
    - WANG et al., "REVIEW OF EXCIPIENTS AND PH'S FOR PARENTERAL PRODUCTAS USED IN THE UNITED STATES", Journal of the Parenteral Drug Association, (19800000), vol. 34, no. 6, pages 452 - 462, XP000618709
    - Dr. Otto M. Kranz, Vademecum für Pharmazeuten, 16.überbearbeitete und erweiterte Auflage, Editio Cantor Verlag, (19950000), pages 2pp, 83 - 84, ISBN 978-3-87193-161-1, XP055327281
    - Ainley Wade, MARTINDALE The Extra Pharmacopoeia, Twenty-seventh Edition, The Pharmaceutical Press, (19770600), page 2pp, 331-332, 1235, 1400, 1401, 1409, 1529, 1536, ISBN 978-0-85369-114-3, XP055327296
    - "Konzentrationsangaben", Dr. Engelbert Graf, Dr. Christian Beyer, Propädeutische Arzneiformenlehre Einführung in die Arzneiformenherstellung in der Apotheke, Wissenschaftliche Verlagsgesellschaft mbH, (19930000), page 1pp, 21, XP055327306
    - "Galenik fur den Tierversuch- Applikation von Forschungssubstanzen", Dagmar Fischer, Jörg Breitenbach, Die Pharmaindustrie Einblick-Durchblick-Perspektiven, Spektrum Akademischer Verlag, (20030000), page 2pp, 97, ISBN 978-3-8274-1374-1, XP055327317
    - WAKELING et al., "ICI 182,780, a new antiestrogen with clinical potential", JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY,, (19920000), vol. 43, no. 1-3, pages 173 - 177, XP023549293

DOI:   http://dx.doi.org/10.1016/0960-0760(92)90204-V
    - Karlfried Karzel, Rainer Liedtke, Allgemeine Pharmakologie Einführung in die Grundlagen der Pharmakotherapie, Gustav Fischer Verlag, (19770000), pages 2pp, 88 - 89, XP055327324
    - Astra Zeneca Pharmaceuticals Lp, "Faslodex fulvestrant injection", Leaflet NDA 21-344/S-001 /Rev 02-13-03/, pages 3 - 17, URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21344se8-001_faslodex_lbl.pdf, XP055327341