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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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|
|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)
Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.
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
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.
|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|