Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pregabalin Pfizer   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Pregabalina Pfizer (PT)
Auth. number : EU/1/14/916
INN : pregabalin
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX16 - Pregabalin
(See WHO ATC Index)
Indication: Neuropathic pain
Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy
Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised Anxiety Disorder
Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
14/04/2014 Centralised - Authorisation EMEA/H/C/3880 (2014)2593 of 10/04/2014
24/07/2014 Centralised - Variation EMEA/H/C/3880/IB/1
04/09/2014 Centralised - Notification EMEA/H/C/3880/N/3