Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Plegridy   
Auth. number : EU/1/14/934
Active substance : peginterferon beta-1a
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AB - Interferons
Chemical substance: L03AB13 - Peginterferon beta-1a
(See WHO ATC Index)
Indication: Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis
Marketing Authorisation Holder: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, 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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/07/2014 Centralised - Authorisation EMEA/H/C/2827 (2014)5264 of 18/07/2014
09/09/2014 Centralised - Variation EMEA/H/C/2827/IB/2
Updated with Decision(2015)6275 of 08/09/2015
24/10/2014 Centralised - Notification EMEA/H/C/2827/N/5
Updated with Decision(2015)6275 of 08/09/2015
22/01/2015 Centralised - Variation EMEA/H/C/2827/II/4/G
Updated with Decision(2015)6275 of 08/09/2015
26/06/2015 Centralised - Variation EMEA/H/C/2827/IAin/10
Updated with Decision(2015)6275 of 08/09/2015
10/09/2015 Centralised - Yearly update (2015)6275 of 08/09/2015
17/09/2015 Centralised - Variation EMEA/H/C/2827/WS/806
Updated with Decision(2016)5828 of 08/09/2016
29/10/2015 Centralised - Variation EMEA/H/C/2827/WS/805
Updated with Decision(2016)5828 of 08/09/2016
15/12/2015 Centralised - Notification EMEA/H/C/2827/N/22
Updated with Decision(2016)5828 of 08/09/2016
11/02/2016 Centralised - Notification EMEA/H/C/2827/N/23
Updated with Decision(2016)5828 of 08/09/2016
30/06/2016 Centralised - Notification EMEA/H/C/2827/N/28
Updated with Decision(2016)5828 of 08/09/2016
12/09/2016 Centralised - Yearly update (2016)5828 of 08/09/2016
15/12/2016 Centralised - Variation EMEA/H/C/2827/II/31/G
18/05/2017 Centralised - Variation EMEA/H/C/2827/IB/36