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- Flebogamma DIF
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Flebogamma DIF
|
| Auth. number : | EU/1/07/404 |
| INN : | Human normal immunoglobulin (IVIg) |
| ATC: | J - General antiinfectives for systemic use J06 - Immune sera and immunoglobulins J06B - Immunoglobulins J06BA - Immunoglobulins, normal human J06BA02 - Immunoglobulins, normal human, for intravascular administration (See WHO ATC Index) |
| Indication: | Replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, Wiskott Aldrich syndrome; Myeloma or chronic |
| Marketing Authorisation Holder: | Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa |
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 |
| 27/08/2007 | Centralised - Authorisation | EMEA/H/C/781 | (2007)4052 of 23/08/2007 | |||
| 31/03/2008 | Centralised - Variation | EMEA/H/C/781/N/1 | ||||
| Updated with Decision(2009)6061 of 24/07/2009 | ||||||
| 30/07/2009 | Centralised - Variation | EMEA/H/C/781/II/5 | (2009)6061 of 24/07/2009 | |||
| 16/04/2010 | Centralised - Variation | EMEA/H/C/781/IA/7 | ||||
| 27/05/2010 | Centralised - Variation | EMEA/H/C/781/IA/8 | ||||
| 13/08/2010 | Centralised - Variation | EMEA/H/C/781/II/9 | ||||
| 03/09/2010 | Centralised - Variation | EMEA/H/C/781/IA/10 | ||||
| Updated with Decision(2010)9288 of 13/12/2010 | ||||||
| 17/11/2010 | Centralised - Variation | EMEA/H/C/781/IA/11 | ||||
| 15/12/2010 | Centralised - Variation | EMEA/H/C/781/X/6 | (2010)9288 of 13/12/2010 | |||
| 28/03/2011 | Centralised - Variation | EMEA/H/C/781/IA/12 | ||||
| 15/03/2012 | Centralised - Variation | EMEA/H/C/781/IB/16 | ||||
| Updated with Decision(2012)6152 of 30/08/2012 | ||||||
| 04/09/2012 | Centralised - Renewal | EMEA/H/C/781/R/17 | (2012)6152 of 30/08/2012 |