ACTIVE SUBSTANCE / INN

SINAPULTIDE;DIPALMITOYLPHOSPHATIDYLCHOLINE;PALMITOYL-OLEOYL PHOSPHATIDYLGLYCEROL;PALMITIC ACID

Brand name(s): Surfaxin

EMA LISTED

APPLICATION WITHDRAWN

Respiratory Distress Syndrome, Newborn

ACTIVE SUBSTANCE

Sinapultide;Dipalmitoylphosphatidylcholine;Palmitoyl-Oleoyl Phosphatidylglycerol;Palmitic Acid

REGULATORS

EMA

SPONSORS / MAH

Pharm Research Associates (UK) Limited

TOTAL APPLICATIONS

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Surfaxin	Pharm Research Associates (UK) Limited	Application withdrawn		Respiratory Distress Syndrome, Newborn

FULL INTELLIGENCE ON SINAPULTIDE;DIPALMITOYLPHOSPHATIDYLCHOLINE;PALMITOYL-OLEOYL PHOSPHATIDYLGLYCEROL;PALMITIC ACID