- Eflfig 3319‘ Commission
`
`Euro :-e an
`[BIT T153 0 ‘—
`
`Community register of medicinal products
`for human use
`
`AUTHORISED
`
`Product information
`
`Invented name:
`Auth. number :
`
`Ventavis a
`EUI1/03I255
`
`Active substance :
`
`lloprost
`
`lndlcat'on:
`Marketing
`Authorisation
`Holder:
`
`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
`
`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
`
`Decision
`
`summarydecision
`publ
`docs
`
`annex
`
`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: BO1A - Antithrombotic agents
`Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding
`Heparin
`Chemical substance: BO1AC11 - lloprost
`(See WHO ATC Index)
`
`18/09/2003
`
`_
`Centra“sed
`Authorisation
`16/04/2004Centralised-Notification EMEA/H/C/474/N/1
`
`EMEA/H/C/474
`
`_
`
`sum v
`
`(2003)3348
`of
`1—6/09/2003
`(2004l1486 sum v
`of
`
`dec
`
`dec
`
`v
`
`Y
`
`anx
`
`anx
`
`'
`
`Y
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1043, p. 1 of 4
`
`

`

`14/10/2004Centralised - Notification EMEA/H/C/474/N/2
`
`13/04/2004
`
`Updated with
`Decision(2005)660 of
`07/03/2005
`25/11/2004Centralised - Notification EMEA/H/C/474/N/4
`
`Updated with
`Decision(2005)3436 of
`05/09/2005
`
`.
`gir‘stég's'fi‘ehfnnua'
`
`EMEA/H/C/474/S/3
`
`EMEA/H/C/474/ll/5
`
`EMEA/H/C/474/Il/6
`
`Centralised - Annual
`reassessment
`
`EMEA/H/C/474/S/7
`
`12/06/2006Centralised - Variation
`
`EMEA/H/C/474/ll/8
`
`Centralised - Variation (no
`27/09/2006change in Commission
`Decision)
`Centralised - Annual
`29/01/2007reassessment
`10/04/2007Centralised - Variation
`
`EMEA/H/C/474/Il/9
`
`EMEA/H/C/474/S/10
`EMEA/H/C/474/IA/12
`
`Updated with
`Decision(2007)2347 of
`30/05/2007
`
`(2005)660
`o_f
`07/03/2005
`
`sum
`
`(2005)3436
`o_f
`05/09/2005
`
`(2006)1884
`o_f
`02/05/2006
`
`sum
`
`sum
`
`(2006)2303
`of
`08/06/2006
`
`sum
`
`
`
`01/06/2007Centralised - Variation
`
`EMEA/H/C/474/ll/11
`
`04/10/2007Centralised - Notification EMEA/H/C/474/N/13
`
`(2007)2347
`o_f
`30/05/2007
`
`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
`
`EMEA/H/C/474/lA/16
`
`E MEA/H/C/474/S/15
`
`Centralised - Variation (no
`31/03/2008change in Commission
`Decision)
`20/06/2008Centralised - Variation
`
`EMEA/H/C/474/ll/17
`
`EMEA/H/C/474/lA/21
`
`Updated with
`Decision(2008)4111 of
`28/07/2008
`
`30/07/2008Centralised-Variation
`
`EMEA/H/C/474/ll/19,
`20
`
`04/09/2008Centralised-Renewal
`
`EMEA/H/C/474/R/18
`
`31/10/2008Centralised - Variation
`
`EMEA/H/C/474/lA/24
`
`Updated with
`Decision(2009)4240 of
`
`2008 4111
`of
`2_8/07/2008
`
`(2008)4951
`o_f
`02/09/2008
`
`sum V
`
`dec
`
`V
`
`anx
`
`v
`
`sum V
`
`dec
`
`1'
`
`anx
`
`1*
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1043, p. 2 of 4
`
`

`

`27/05/2009
`31/10/2008Centralised - Variation
`
`EMEA/H/C/474/lA/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)
`.
`centra"sed'A“””a'
`reassessment
`
`29/05/2009
`
`EMEA/H/C/474/lB/26
`
`EMEA/H/C/474/lB/27
`
`EMEA/H/C/474/S/25
`
`(2009)4240
`o_f
`27/05/2009
`
`sum v
`
`dec
`
`v
`
`anx
`
`v
`
`22/06/20090entralised - Notification EMEA/H/C/474/N/28
`
`Updated with
`Decision(2010)1952 of
`19/03/2010
`17/11/2009 Centralised - Variation
`
`Updated with
`Decision(2010)1952 of
`19/03/2010
`
`EMEA/H/C/474/lA/29
`
`20101952
`of
`19/03/2010
`
`sum v
`
`dec
`
`v
`
`anx
`
`v
`
`26/08/2013
`
`23/03/2010
`
`_
`.
`Centra"sed Annua'
`reassessment
`18/05/201OCentralised - Notification EMEA/H/C/474/N/31
`
`EMEA/H/C/474/S/30
`
`Updated with
`Decision(2010)9626 of
`20/12/2010
`
`Centralised - Variation (no
`03/08/20100hange in Commission
`Decision)
`30/09/201OCentralised - Notification EMEA/H/C/474/N/35
`
`EMEA/H/C/474/lA/34/G
`
`Updated with
`Decision(2010)9626 of
`20/12/2010
`
`23/12/201OCentralised - Variation
`
`EMEA/H/C/474/ll/32
`
`Centralised - Annual
`21/01/2011 reassessment
`
`EMEA/H/C/474/S/36
`
`23/02/2011Centralised - Variation
`
`EMEA/H/C/474/ll/33
`
`16/08/2011 Centralised - Variation
`
`EMEA/H/C/474/lA/37/G
`
`(2010)9626
`o_f
`20/12/2010
`
`sum
`
`(2011 )1187
`o_f
`21/02/2011
`
`sum
`
`Updated with
`Decision(2012)1859 of
`15/03/2012
`
`19/03/2012
`
`.
`gifgggzfie'nf‘mua'
`
`EMEA/H/C/474/S/39
`
`(2012)1859
`o_f
`15/03/2012
`
`sum
`
`26/04/20120entralised - Variation
`
`(2012)2856
`EMEA/H/C/474/ll/38/G o_f
`20/04/2012
`
`sum
`
`14/12/20120entralised - 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
`
`sum
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1043, p. 3 of 4
`
`

`

`18/09/2013Centralised - (orphan
`status)
`21/ 11/2013Centralised - Variation
`
`EMEA/H/C/474/ll/44
`
`Updated with
`Decision(2014)5247 of
`18/07/2014
`
`22/07/2014Centralised - Variation
`
`(2014)5247
`EMEA/H/C/474/X/43 g
`18/07/2014
`
`sum v
`
`dec
`
`Y
`
`anx
`
`Y
`
`06/11/2014Centralised - Variation
`
`EMEA/H/C/474/lA/48
`
`Updated with
`Decision(2015)7734 of
`03/11/2015
`06/11/2014Centralised - Variation
`
`Updated with
`Decision(2015)7734 of
`03/ 11/2015
`Centralised-Yearly
`update
`13/10/2016Centralised - Variation
`
`05/11/2015
`
`EMEA/H/C/474/lA/49
`
`£01517?“ sum v
`03/11/2015
`
`dec
`
`v
`
`anx
`
`v
`
`E MEA/H/C/474/ll/51/G
`
`Last check for updates:21/06/2017 | T_op
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1043, p. 4 of 4
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1043, p. 4 of 4
`
`