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
24/10/2014 Centralised - Notification EMEA/H/C/2827/N/5
22/01/2015 Centralised - Variation EMEA/H/C/2827/II/4/G