EMEA-002007-PIP02-17

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Overview

Product details for -
Invented name-
Active substance

Cemiplimab

Decision numberP/0385/2017
PIP numberEMEA-002007-PIP02-17
Pharmaceutical form(s)Solution for infusion
Condition(s)/indication(s)

Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)

Route(s) of administrationIntravenous use
PIP applicant

Regeneron Ireland U.C.
Tel. + 353 14112200
E-mail: EU-RegAffairs@regeneron.com

Decision typeP: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision