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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Velmetia
|
| Auth. number : | EU/1/08/456 |
| INN : | sitagliptin / metformin hydrochloride |
| ATC: | A - Alimentary tract and metabolism A10 - Drugs used in diabetes A10B - Blood glucose lowering drugs, excluding insulins A10BD - Combinations of oral blood glucose lowering drugs A10BD07 - Metformin and sitagliptin (See WHO ATC Index) |
| Indication: | For adult patients with type 2 diabetes mellitus: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Velmetia is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. |
| Marketing Authorisation Holder: | Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 18/07/2008 | Centralised - Authorisation | EMEA/H/C/862 | (2008)3871 of 16/07/2008 | |||
| 02/09/2008 | Centralised - Variation | EMEA/H/C/862/IA/3 | ||||
| 22/10/2008 | Corrigendum | - | ||||
| 13/11/2008 | Centralised - Variation | EMEA/H/C/862/N/2 | ||||
| Updated with Decision(2009)4419 of 02/06/2009 | ||||||
| 12/12/2008 | Centralised - Variation | EMEA/H/C/862/IA/5 | ||||
| Updated with Decision(2009)4419 of 02/06/2009 | ||||||
| 12/12/2008 | Centralised - Variation | EMEA/H/C/862/IA/6 | ||||
| Updated with Decision(2009)4419 of 02/06/2009 | ||||||
| 03/03/2009 | Centralised - Variation | EMEA/H/C/862/IA/12 | ||||
| 10/03/2009 | Centralised - Variation | EMEA/H/C/862/N/9 | ||||
| Updated with Decision(2009)4419 of 02/06/2009 | ||||||
| 26/03/2009 | Centralised - Variation | EMEA/H/C/862/IB/10 | ||||
| 26/03/2009 | Centralised - Variation | EMEA/H/C/862/IB/11 | ||||
| 05/06/2009 | Centralised - Variation | EMEA/H/C/862/II/4 | (2009)4419 of 02/06/2009 | |||
| 31/07/2009 | Centralised - Variation | EMEA/H/C/862/II/15 | (2009)6192 of 29/07/2009 | |||
| 18/09/2009 | Centralised - Variation | EMEA/H/C/862/II/13 | (2009)7092 of 16/09/2009 | |||
| 09/10/2009 | Centralised - Variation | EMEA/H/C/862/IA/17 | ||||
| 20/10/2009 | Centralised - Variation | EMEA/H/C/862/IB/16 | ||||
| 30/10/2009 | Centralised - Variation | EMEA/H/C/862/II/14 | (2009)8499 of 28/10/2009 | |||
| 07/05/2010 | Centralised - Variation | EMEA/H/C/862/I/G | ||||
| Updated with Decision(2010)5610 of 06/08/2010 | ||||||
| 12/05/2010 | Centralised - Variation | EMEA/H/C/862/IG/2 | ||||
| 09/06/2010 | Centralised - Variation | EMEA/H/C/862/IG/8 | ||||
| 29/07/2010 | Centralised - Variation | EMEA/H/C/862/N/27 | ||||
| Updated with Decision(2010)7741 of 03/11/2010 | ||||||
| 04/08/2010 | Centralised - Variation | EMEA/H/C/862/IG/16 | ||||
| 11/08/2010 | Centralised - Variation | EMEA/H/C/862/WS/9 | (2010)5610 of 06/08/2010 | |||
| 01/10/2010 | Centralised - Variation | EMEA/H/C/862/N/28 | ||||
| Updated with Decision(2010)8570 of 26/11/2010 | ||||||
| 09/11/2010 | Centralised - Variation | EMEA/H/C/862/WS/26 | (2010)7741 of 03/11/2010 | |||
| 18/11/2010 | Centralised - Variation | EMEA/H/C/862/IG/27/G | ||||
| Updated with Decision(2011)1203 of 21/02/2011 | ||||||
| 01/12/2010 | Centralised - Variation | EMEA/H/C/862/WS/46 | (2010)8570 of 26/11/2010 | |||
| 15/12/2010 | Centralised - Variation | EMEA/H/C/862/N/29 | ||||
| Updated with Decision(2011)1203 of 21/02/2011 | ||||||
| 02/02/2011 | Centralised - Variation | EMEA/H/C/862/IG/42 | ||||
| 14/02/2011 | Centralised - Variation | EMEA/H/C/862/IG/46 | ||||
| 24/02/2011 | Centralised - Variation | - | (2011)1203 of 21/02/2011 | |||
| 18/03/2011 | Centralised - Variation | EMEA/H/C/862/IG/55 | ||||
| 20/05/2011 | Centralised - Variation | EMEA/H/C/862/N/30 | ||||
| Updated with Decision(2011)6151 of 24/08/2011 | ||||||
| 18/07/2011 | Centralised - Variation | EMEA/H/C/862/N/31 | ||||
| Updated with Decision(2011)6151 of 24/08/2011 | ||||||
| 30/08/2011 | Centralised - Variation | EMEA/H/C/862/WS/130 | (2011)6151 of 24/08/2011 | |||
| 28/08/2012 | Centralised - Variation | EMEA/H/C/862/WS/270/G | (2012)6010 of 23/08/2012 | |||
| 20/12/2012 | Centralised - Variation | EMEA/H/C/862/WS/328 | (2012)9870 of 18/12/2012 | |||
| 15/03/2013 | Centralised - Renewal | EMEA/H/C/862/R/50 | (2013)1651 of 13/03/2013 |