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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Rienso
|
| Auth. number : | EU/1/12/774 |
| INN : | Ferumoxytol |
| ATC: | Pending |
| Indication: | Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnostic of iron deficiency must be based on appropriate laboratory tests. |
| Marketing Authorisation Holder: | Takeda Global Research and Development Centre (Europe) Ltd
61 Aldwych, London WC2B 4AE, 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 |
| 20/06/2012 | Centralised - Authorisation | EMEA/H/C/2215 | (2012)4209 of 15/06/2012 | |||
| 01/08/2012 | Centralised - Variation | EMEA/H/C/2215/IA/1/G | ||||
| Updated with Decision(2012)7885 of 29/10/2012 | ||||||
| 20/08/2012 | Centralised - Variation | EMEA/H/C/2215/N/2 | ||||
| Updated with Decision(2012)7885 of 29/10/2012 | ||||||
| 31/10/2012 | Centralised - Variation | - | (2012)7885 of 29/10/2012 |