Page contents Key factsDecisionKey facts Active Substance Suvecaltamide (hydrochloride) Therapeutic area Nervous system disorders Decision number P/0121/2024 PIP number EMEA-003248-PIP02-23 Pharmaceutical form(s) Capsule, hard Condition(s) / indication(s) Treatment of tremor in patients with Parkinson’s disease Route(s) of administration Oral use Contact for public enquiries Jazz Pharmaceuticals Ireland LimitedE-mail: corporateaffairsmediainfo@jazzpharma.comTel: +353 16347800 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 12/04/2024DecisionP/0121/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for suvecaltamide hydrochloride (EMEA-003248-PIP02-23)AdoptedReference Number: EMA/114623/2024 English (EN) (175.22 KB - PDF)First published: 10/06/2025ViewShare this page