Community register of medicinal products for human use
Product information
| Invented name: | Actos |
| INN : | pioglitazone |
| ATC: | |
| Indication: | Diabetes mellitus |
| Marketing Authorisation Holder: | Takeda Global Research and Development Centre (Europe) Ltd |
Package presentations
| EU Number | Presentation | Authorisation date |
| EU/1/00/150/001 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 28 | 13 Oct 2000 |
| EU/1/00/150/002 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 50 | 13 Oct 2000 |
| EU/1/00/150/003 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 98 | 13 Oct 2000 |
| EU/1/00/150/004 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 28 | 13 Oct 2000 |
| EU/1/00/150/005 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 50 | 13 Oct 2000 |
| EU/1/00/150/006 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 98 | 13 Oct 2000 |
| EU/1/00/150/007 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 14 | 16 Feb 2001 |
| EU/1/00/150/008 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 14 | 16 Feb 2001 |
| EU/1/00/150/009 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 56 | 19 Feb 2002 |
| EU/1/00/150/010 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 56 | 19 Feb 2002 |
| EU/1/00/150/011 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 14 | 16 Sep 2003 |
| EU/1/00/150/012 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 28 | 16 Sep 2003 |
| EU/1/00/150/013 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 50 | 16 Sep 2003 |
| EU/1/00/150/014 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 56 | 16 Sep 2003 |
| EU/1/00/150/015 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 98 | 16 Sep 2003 |
| EU/1/00/150/016 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 30 | 29 Mar 2006 |
| EU/1/00/150/017 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 84 | 29 Mar 2006 |
| EU/1/00/150/018 | Actos - 15 mg - Tablet - Oral use - blister (alu/alu) - 90 | 29 Mar 2006 |
| EU/1/00/150/019 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 30 | 29 Mar 2006 |
| EU/1/00/150/020 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 84 | 29 Mar 2006 |
| EU/1/00/150/021 | Actos - 30 mg - Tablet - Oral use - blister (alu/alu) - 90 | 29 Mar 2006 |
| EU/1/00/150/022 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 30 | 29 Mar 2006 |
| EU/1/00/150/023 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 84 | 29 Mar 2006 |
| EU/1/00/150/024 | Actos - 45 mg - Tablet - Oral use - blister (alu/alu) - 90 | 29 Mar 2006 |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 19/10/2000 | Centralised - Autorisation | EMEA/H/C/285 | C(2000)2827 of 13/10/2000 | |||
| 8/12/2000 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/285/I/1 | ||||
| 8/12/2000 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/285/I/2 | ||||
| 21/02/2001 | Centralised - Variation Type I - (Additional pack size) | EMEA/H/C/285/I/3 | C(2001)241 of 16/02/2001 | |||
| 21/02/2002 | Centralised - Variation Type I - (Additional pack size) | EMEA/H/C/285/I/5 | C(2002)649 of 19/02/2002 | |||
| 16/04/2002 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/6 | C(2002)1495 of 12/04/2002 | |||
| 12/11/2002 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/285/I/4 | ||||
| 29/11/2002 | Centralised - Variation Type I - (Acceptance modification) | EMEA/H/C/285/I/8 | C(2002)4799 of 26/11/2002 | |||
| 15/12/2002 | Centralised - Variation Type I - (No decision, letter only) | EMEA/H/C/285/I/9 | ||||
| 19/03/2003 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/7 | C(2003)842 of 17/03/2003 | |||
| 1/09/2003 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/10-11 | C(2003)3169 of 28/08/2003 | |||
| 18/09/2003 | Centralised - Annex II extension adding new number | EMEA/H/C/285/X/12 | C(2003)3340 of 16/09/2003 | |||
| 20/10/2004 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/15 | ||||
| 11/11/2004 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/16 | ||||
| 29/11/2004 | Centralised - Notification 61(3) - (Acceptance modification) | EMEA/H/C/285/N/14 | ||||
| Updated with Decision C(2005)64 of 10/01/2005 |
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| 12/01/2005 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/13 | C(2005)64 of 10/01/2005 | |||
| 18/03/2005 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/285/IB/17 | ||||
| 14/09/2005 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/285/IA/19 | ||||
| Updated with Decision C(2006)1329 of 29/03/2006 |
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| 18/10/2005 | Centralised - Renewal after maximum 5 years | EMEA/H/C/285/R/18 | C(2005)4084 of 13/10/2005 | |||
| 16/11/2005 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/22 | ||||
| 16/11/2005 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/20 | ||||
| 19/12/2005 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/285/IB/21 | ||||
| 27/02/2006 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/285/IA/27 | ||||
| Updated with Decision C(2006)1329 of 29/03/2006 |
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| 31/03/2006 | Centralised - Update Type IA - (Acceptance modification) | - | C(2006)1329 of 29/03/2006 | |||
| 19/05/2006 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/285/IA/28 | ||||
| Updated with Decision C(2006)3382 of 20/07/2006 |
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| 26/07/2006 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/26 | C(2006)3382 of 20/07/2006 | |||
| 4/09/2006 | Centralised - Notification 61(3) - (Acceptance modification) | EMEA/H/C/285/N/30 | ||||
| Updated with Decision C(2006)5203 of 26/10/2006 |
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| 30/10/2006 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/24-29 | C(2006)5203 of 26/10/2006 | |||
| 8/11/2006 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/285/IB/31 | ||||
| 30/01/2007 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/23 | C(2007)312 of 26/01/2007 | |||
| 7/02/2007 | Centralised - Variation Type IB - (No change in original decision or annexes) | EMEA/H/C/285/IB/32 | ||||
| 22/08/2007 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/33 | C(2007)4004 of 20/08/2007 | |||
| 12/12/2007 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/I/34 | ||||
| 12/12/2007 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/I/35 | ||||
| 13/12/2007 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/36 | ||||
| 9/07/2008 | Centralised - Variation Type IA - (No change in original decision or annexes) | EMEA/H/C/285/IA/37 | ||||
| 16/02/2009 | Centralised - Variation Type IA - (Acceptance modification) | EMEA/H/C/285/IA/39 | ||||
| Updated with Decision C(2009)7139 of 17/09/2009 |
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| 3/04/2009 | Centralised - Notification 61(3) - (Acceptance modification) | EMEA/H/C/285/N/38 | ||||
| Updated with Decision C(2009)7139 of 17/09/2009 |
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| 21/09/2009 | Centralised - Variation Type II - (Acceptance modification) | EMEA/H/C/285/II/41 | C(2009)7139 of 17/09/2009 |
