European approval remodulin when?

When was Remodulin first approved in Europe?

Remodulin (treprostinil) received European approval in 2006 for pulmonary arterial hypertension (PAH) [1].

When did approvals expand to additional forms (e.g., SC/IV and other labels)?

European approval dates for each Remodulin formulation/indication depend on the specific authorization (initial approval vs later label updates). The provided information only confirms the 2006 European approval for Remodulin in PAH [1].

What does “European approval” usually mean for timing?

“European approval” typically refers to an authorization from the European Medicines Agency (EMA) and the resulting EU-wide marketing authorization. In the case of Remodulin, the key date given is the 2006 EU authorization [1].

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761370