EMEA-000275-PIP01-08

Key facts

Active substance	Rolofylline
Therapeutic area	Cardiovascular diseases
Decision number	P/87/2009
PIP number	EMEA-000275-PIP01-08
Pharmaceutical form(s)	Emulsion for injection
Condition(s) / indication(s)	Heart Failure
Route(s) of administration	Intravenous use
Contact for public enquiries	Merck Sharp & Dohme (Europe), Inc. E-mail: axel_breitstadt@merck.com Country: Belgium Phone: +32 27766045 Fax: +32 27766288
Decision type	P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

List item

P/87/2009: European medicines agency decision of 18 May 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for rolofylline (EMEA-000275-PIP01-08) in accordance with Regulation (EC)... (PDF/35.8 KB)

Adopted

First published: 09/07/2009
Last updated: 09/07/2009
EMEA/288303/2009

Related content

List item

Rolofylline - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (PDF/51.22 KB)

First published: 08/03/2019

How useful was this page?

Add your rating

★ ★ ★ ★ ★