`- Eflfig ggn‘ Commission
`
`Euro :-e an
`Iisn‘ T153 0 ‘—
`
`Community register of medicinal products
`for human use
`
`AUTHORISED
`
`Product information
`
`Invented name:
`Auth. number :
`
`Ventavis a
`EU/1/03l255
`
`Active substance :
`
`lloprost
`
`Orphan market exclusivity for "Treatment of primary and of the following forms of
`secondary pulmonary hypertension: connective tissue disease pulmonary
`hypertension, drug-induced pulmonary hypertension, portopulmonary
`hypertension, pulmonary hypertension associated with congenital heart disease,
`chronic thromboembolic pulmonary hypertension" (based on designation
`EU/3/00/014) started on 18/09/2003
`10 years of market exclusivity
`This orphan market exclusivity has ended on 18/09/2013
`Anatomical main group: B - Blood and blood forming organs
`Therapeutic subgroup: BO1 - Antithrombotic agents
`Pharmacological subgroup: B01A - Antithrombotic agents
`Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding
`Heparin
`Chemical substance: B01AC11 - lloprost
`(See WHO ATC Index)
`
`Treatment of patients with primary pulmonary hypertension, classified as
`NYHA functional class III, to improve exercise capacity and symptoms.
`Bayer Pharma AG
`D-13342 Berlin, Deutschland
`
`ATC:
`
`Indication:
`thfigrtilggtion
`Holder:
`
`EPAR and active package presentations”
`
`Package presentations
`
`Information about presentations can be found in the website of the European Medicines Agency
`under the section "Product Information".
`
`Likewise, presentations on which there has been a Commission decision are referred in the Summary
`of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation)
`which is available in the Community Register.
`
`European Commission procedures:
`
`Close
`date
`procedure
`
`Procedure type
`
`EMEA number
`
`.
`_
`18/09/2003g‘jmgfltaetfion
`
`EMEA/H/C/474
`
`16/04/2004Centralised-Notification EMEA/H/C/474/N/1
`
`.
`.
`Decision summarydeCISIonannex
`publ
`docs
`
`(200313348
`o_f
`16/09/2003
`
`sum v
`
`I2004)1486 sum v
`o_f
`
`dec
`
`dec
`
`v
`
`Y
`
`anx
`
`anx
`
`v
`
`Y
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 1 of 4
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 1 of 4
`
`
`
`14/10/2004Centralised - Notification
`
`E M EA/H/C/474/N/2
`
`13/04/2004
`
`Updated with
`Decision(2005)660 of
`07/03/2005
`25/11/2004 Centralised - Notification
`
`Updated with
`Decision(2005)3436 of
`05/09/2005
`
`E M EA/H/C/474/N/4
`
`09/03/2005
`
`Centralised - Annual
`reassessment
`
`EMEA/H/C/474/S/3
`
`08/09/20050entralised - Variation
`
`EMEA/H/C/474/Il/5
`
`O4/05/2006Centralised - Variation
`
`EMEA/H/C/474/Il/6
`
`01/06/2006
`
`Centralised - Annual
`reassessment
`
`EMEA/H/C/474/S/7
`
`12/06/2006Centralised - Variation
`
`EMEA/H/C/474/Il/8
`
`Centralised - Variation (no
`27/09/20060hange in Commission
`Decision)
`Centralised - Annual
`reassessment
`10/04/2007Centralised - Variation
`
`29/01/2007
`
`EMEA/H/C/474/Il/9
`
`E M EA/H/C/474/S/10
`
`E M EA/H/C/474/IA/12
`
`Updated with
`Decision(2007)2347 of
`30/05/2007
`
`120051660
`g
`07/03/2005
`
`1200513436
`g
`05/09/2005
`
`1200611884
`o_f
`02/05/2006
`
`1200612303
`o_f
`08/06/2006
`
`sum V
`
`dec
`
`'
`
`anx
`
`sum V
`
`dec
`
`V
`
`anx
`
`sum V
`
`dec
`
`V
`
`anx
`
`sum V
`
`dec
`
`V
`
`anx
`
`01/06/2007Centralised - Variation
`
`EMEA/H/C/474/I |/11
`
`04/10/2007Centralised - Notification
`
`E M EA/H/C/474/N/13
`
`1200712347
`g
`M
`
`sum V
`
`dec
`
`V
`
`anx
`
`Y
`
`Updated with
`Decision(2008)4111 of
`28/07/2008
`16/01/2008Centralised - Variation
`
`Updated with
`Decision(2008)4111 of
`28/07/2008
`Centralised - Annual
`reassessment
`
`24/01/2008
`
`E M EA/H/C/474/IA/16
`
`EMEA/H/C/474/S/15
`
`Centralised - Variation (no
`31/03/2008change in Commission
`Decision)
`20/06/2008Centralised - Variation
`
`E M EA/H/C/474/Il/17
`
`E M EA/H/C/474/IA/21
`
`Updated with
`Decision(2008)4111 of
`28/07/2008
`
`30/07/2008Centralised - Variation
`
`EMEA/H/C/474/Il/19,
`20
`
`04/09/2008Centralised - Renewal
`
`E M EA/H/C/474/R/18
`
`31/1 O/2008Centralised - Variation
`
`E M EA/H/C/474/IA/24
`
`Updated with
`Decision(2009)4240 of
`
`1200814111
`o_f
`28/07/2008
`
`1200814951
`o_f
`02/09/2008
`
`sum V
`
`dec
`
`V
`
`anx
`
`sum V
`
`dec
`
`Y
`
`anx
`
`V
`
`V
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 2 of 4
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 2 of 4
`
`
`
`27/05/2009
`31/10/20080entralised - Variation
`
`EMEA/H/C/474/IA/23
`
`Updated with
`Decision(2009)4240 of
`27/05/2009
`
`Centralised - Variation (no
`18/02/20090hange in Commission
`Decision)
`Centralised - Variation (no
`31/03/20090hange in Commission
`Decision)
`
`29/05/2009
`
`Centralised - Annual
`reassessment
`
`E M EA/H/C/474/I B/26
`
`EMEA/H/C/474/IB/27
`
`(2009 )4240
`E M EA/H/C/474/S/25 g
`27/05/2009
`
`sum V
`
`dec
`
`V
`
`anx
`
`V
`
`22/06/2009Centralised - Notification
`
`EMEA/H/C/474/N/28
`
`Updated with
`Decision(2010)1952 of
`19/03/2010
`17/11/20090entralised - Variation
`
`Updated with
`Decision(2010)1952 of
`19/03/2010
`
`EMEA/H/C/474/IA/29
`
`23/03/201 0
`
`Centralised - Annual
`reassessment
`
`EMEA/H/C/474/S/30
`
`18/05/201OCentralised - Notification
`
`E M EA/H/C/474/N/31
`
`(2010)1952
`of
`1—9/03/201 0
`
`sum V
`
`dec
`
`V
`
`anx
`
`V
`
`Updated with
`Decision(2010)9626 of
`20/12/2010
`
`Centralised - Variation (no
`03/08/20100hange in Commission
`Decision)
`30/09/201OCentralised - Notification
`
`E M EA/ H/C/474/ |A/34/G
`
`EMEA/H/C/474/N/35
`
`Updated with
`Decision(2010)9626 of
`20/12/2010
`
`23/12/2010Centralised - Variation
`
`(2010)9626
`E M EA/H/C/474/I |/32 g
`20/12/2010
`
`sum V
`
`dec
`
`V
`
`anx
`
`Centralised - Annual
`21/01/2011 reassessment
`
`EMEA/H/C/474/S/36
`
`23/02/2011 Centralised - Variation
`
`(2011 )1187
`EMEA/H/C/474/Il/33 g
`21/02/2011
`
`sum V
`
`dec
`
`V
`
`anx
`
`16/08/2011 Centralised - Variation
`
`EMEA/H/C/474/IA/37/G
`
`Updated with
`Decision(2012)1859 of
`15/03/2012
`
`19/03/2012
`
`Centralised - Annual
`reassessment
`
`EMEA/H/C/474/S/39
`
`(2012)1859
`o_f
`15/03/2012
`
`sum V
`
`dec
`
`V
`
`anx
`
`26/04/20120entralised - Variation
`
`(2012)2856
`EMEA/H/C/474/Il/38/G o_f
`20/04/2012
`
`sum V
`
`dec
`
`V
`
`anx
`
`14/12/2012Centralised - Notification
`
`EMEA/H/C/474/N/40
`
`Updated with
`Decision(2013)5613 of
`26/08/2013
`
`29/08/2013Centralised - Renewal
`
`EMEA/H/C/474/R/42
`
`(2013)5613
`o_f
`26/08/2013
`
`sum V
`
`dec
`
`V
`
`anx
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 3 of 4
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 3 of 4
`
`
`
`18/09/2013Centralised - (orphan
`status)
`21/11/2013Centralised - Variation
`
`EMEA/H/C/474/Il/44
`
`Updated with
`Decision(2014)5247 of
`18/07/2014
`
`22/07/2014Centralised - Variation
`
`E M EA/H/C/474/X/43
`
`06/11/2014Centralised - Variation
`
`E M EA/H/C/474/IA/48
`
`1201415247
`o_f
`18/07/2014
`
`sum V
`
`dec
`
`Y
`
`anx
`
`V
`
`sum V
`
`dec
`
`v
`
`anx
`
`V
`
`1201517734
`
`g0
`
`3/11/2015
`
`Updated with
`Decision(2015)7734 of
`03/11/2015
`06/11/2014Centralised - Variation
`
`Updated with
`Decision(2015)7734 of
`03/11/2015
`
`05/11/2015
`
`Centralised - Yearly
`update
`
`E M EA/H/C/474/IA/49
`
`13/10/2016Centralised - Variation
`
`EMEA/H/C/474/Il/51/G
`
`Last check for updatesz21/06/2017 | T_op
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 4 of 4
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1043, p. 4 of 4
`
`