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- Repaglinide Accord
Pharmaceuticals - Union Register
Union Register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Repaglinide Accord
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Auth. number : | EU/1/11/743 |
Active substance : | Repaglinide |
ATC: | Anatomical main group: A - Alimentary tract and metabolism Therapeutic subgroup: A10 - Drugs used in diabetes Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins Chemical subgroup: A10BX - Other oral blood glucose lowering drugs Chemical substance: A10BX02 - repaglinide (See WHO ATC Index) |
Indication: | Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
Marketing Authorisation Holder: | Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
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 Union Register. |
European Commission procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
28/12/2011 | Centralised - Authorisation | EMEA/H/C/2318 | (2011)10092 of 22/12/2011 | |||
27/07/2012 | Centralised - Variation | EMEA/H/C/2318/IB/2 | ||||
Updated with Decision(2012)8011 of 31/10/2012 | ||||||
12/11/2012 | Centralised - Variation | (2012)8011 of 31/10/2012 | ||||
15/09/2015 | Centralised - Variation | EMEA/H/C/2318/IAIN/4/G | ||||
Updated with Decision(2016)6091 of 19/09/2016 | ||||||
21/09/2016 | Centralised - Renewal | EMEA/H/C/2318/R/5 | (2016)6091 of 19/09/2016 | |||
4/10/2018 | Centralised - Variation | EMEA/H/C/2318/IAIN/7/G | ||||