Committee for Medicinal Products for Human Use Post-authorisation Summary of Opinion for Lyrica
Pregabalin
LONDON, July 27, 2006-On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion?? To recommend the variation to the terms of the marketing authorisation for the medicinal product Lyrica. The Marketing Authorisation Holder for this medicinal product is Pfizer Limited.
The New indication adopted by CHMP is: "Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults."
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication of Lyrica will be as follows???:
"Neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy
Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
LYRICA is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults."
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
LONDON, July 27, 2006-On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion?? To recommend the variation to the terms of the marketing authorisation for the medicinal product Lyrica. The Marketing Authorisation Holder for this medicinal product is Pfizer Limited.
The New indication adopted by CHMP is: "Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults."
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication of Lyrica will be as follows???:
"Neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy
Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
LYRICA is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults."
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
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