EMEA-001152-PIP02-16

Key facts

Active substance
Recombinant modified human growth hormone
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0121/2017
PIP number
EMEA-001152-PIP02-16
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of growth hormone deficiency
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Richardson Associates Regulatory Affairs Ltd
Israel
Tel.: +972 89300051
Fax: +972 89300091
E-mail: contact_opkobiologics@opko.com
Decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan

Decision

How useful was this page?

Add your rating