№ files_lp_3_process_7_085013
Year: 2021
Region / City: Australia
Topic: Neuropathic pain, Pregabalin CR, Pharmaceutical Submission
Document Type: Submission for Pharmaceutical Listing
Organization: Upjohn Australia Pty Ltd
Author: Not specified
Target Audience: Medical Practitioners, Pharmaceutical Regulators
Action Period: Not specified
Approval Date: 10 March 2021
Modification Date: Not specified
Clinical Criteria: Condition must be refractory to other treatments
PBS Indication: Neuropathic pain in adults
Treatment Phase: Initial and continuing
Prescriber: Medical Practitioners, Nurse Practitioners for continuing therapy
Source: Therapeutic Goods Administration (TGA)
Background: Pregabalin CR tablets were registered in Australia in March 2021 for neuropathic pain in adults.
Purpose of Submission: Request for listing pregabalin CR on the PBS for neuropathic pain treatment under the same clinical criteria as pregabalin IR
International Registration Status: Approved in the USA (2017) and Republic of Korea (2018) for neuropathic pain treatment
Requested Listing: Pregabalin CR tablets for inclusion in PBS under a General Schedule (GE)
Price: 8 / 10 USD
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