Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Thyrogen   
Auth. number : EU/1/99/122
INN : Thyrotropin alfa
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01A - Anterior pituitary lobe hormones
Chemical subgroup: H01AB - Thyrotropin
Chemical substance: H01AB01 - Thyrotropin
(See WHO ATC Index)
Indication: Indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.
Indicated for pre-therapeutic stimulation in combination with 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland

  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 proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/03/2000 Centralised - Authorisation EMEA/H/C/220 (2000)577 of 09/03/2000
05/07/2001 Centralised - Variation EMEA/H/C/220/I/1
05/07/2001 Centralised - Variation EMEA/H/C/220/I/4
05/07/2001 Centralised - Variation EMEA/H/C/220/I/2, 3
08/10/2001 Centralised - Variation EMEA/H/C/220/II/6
17/10/2001 Centralised - Variation EMEA/H/C/220/II/5 (2001)2848 of 16/10/2001
22/02/2002 Centralised - Variation EMEA/H/C/220/N/7 (2002)631 of 19/02/2002
22/02/2002 Centralised - Variation EMEA/H/C/220/I/8 (2002)642 of 19/02/2002
04/06/2002 Centralised - Variation EMEA/H/C/220/II/9
27/09/2002 Centralised - Variation EMEA/H/C/220/I/10
02/06/2003 Centralised - Variation EMEA/H/C/220/II/12
03/07/2003 Centralised - Variation EMEA/H/C/220/II/11 (2003)2123 of 26/06/2003
01/09/2003 Centralised - Variation EMEA/H/C/220/N/14 (2003)3174 of 28/08/2003
30/09/2003 Centralised - Variation EMEA/H/C/220/II/13
04/08/2004 Centralised - Variation EMEA/H/C/220/N/15
Updated with Decision(2005)944 of 16/03/2005
28/10/2004 Centralised - Variation EMEA/H/C/220/II/17
24/11/2004 Centralised - Variation EMEA/H/C/220/II/16
27/01/2005 Centralised - Variation EMEA/H/C/220/IB/22
31/01/2005 Centralised - Variation EMEA/H/C/220/II/19
31/01/2005 Centralised - Variation EMEA/H/C/220/II/20
25/02/2005 Centralised - Variation EMEA/H/C/220/II/18 (2005)478 of 23/02/2005
18/03/2005 Centralised - Renewal EMEA/H/C/220/R/21 (2005)944 of 16/03/2005
25/04/2005 Centralised - Variation EMEA/H/C/220/II/23
19/10/2005 Centralised - Variation EMEA/H/C/220/II/24
01/12/2005 Centralised - Variation EMEA/H/C/220/IB/25
17/01/2006 Centralised - Variation EMEA/H/C/220/N/27
Updated with Decision(2007)90 of 09/01/2007
03/05/2006 Centralised - Variation EMEA/H/C/220/II/26
21/11/2006 Centralised - Variation EMEA/H/C/220/II/29
11/01/2007 Centralised - Variation EMEA/H/C/220/II/28 (2007)90 of 09/01/2007
08/10/2007 Centralised - Variation EMEA/H/C/220/II/30 (2007)4656 of 04/10/2007
26/11/2007 Centralised - Variation EMEA/H/C/220/II/31
15/04/2008 Centralised - Variation EMEA/H/C/220/IB/33
13/06/2008 Centralised - Variation EMEA/H/C/220/N/34
Updated with Decision(2009)2878 of 07/04/2009
27/10/2008 Centralised - Variation EMEA/H/C/220/II/35
17/12/2008 Centralised - Variation EMEA/H/C/220/IB/36
09/04/2009 Centralised - Variation EMEA/H/C/220/II/37 (2009)2878 of 07/04/2009
07/05/2009 Centralised - Variation EMEA/H/C/220/II/39
07/05/2009 Centralised - Variation EMEA/H/C/220/IB/40
24/08/2009 Centralised - Variation EMEA/H/C/220/IA/43
08/10/2009 Centralised - Variation EMEA/H/C/220/II/41
24/11/2009 Centralised - Variation EMEA/H/C/220/IA/45
19/01/2010 Centralised - Renewal EMEA/H/C/220/II/R/42 (2010)185 of 15/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/220/II/38 (2010)373 of 20/01/2010
03/02/2010 Centralised - Variation EMEA/H/C/220/II/44
07/05/2010 Centralised - Variation EMEA/H/C/220/IA/47
Updated with Decision(2010)6247 of 06/09/2010
29/06/2010 Centralised - Variation EMEA/H/C/220/II/46
22/07/2010 Centralised - Variation EMEA/H/C/220/IB/48
09/09/2010 Centralised - Variation (2010)6247 of 06/09/2010
24/02/2011 Centralised - Variation EMEA/H/C/220/II/49/G
30/08/2011 Centralised - Variation EMEA/H/C/220/II/51 (2011)6156 of 24/08/2011
07/05/2012 Centralised - Variation EMEA/H/C/220/N/58
Updated with Decision(2012)8709 of 22/11/2012
27/11/2012 Centralised - Variation EMEA/H/C/220/II/59 (2012)8709 of 22/11/2012
11/04/2013 Corrigendum (2013)2107 of 09/04/2013
30/10/2013 Centralised - Variation EMEA/H/C/220/N/66