EMEA-001634-PIP01-14
Key facts
| Active substance |
Recombinant human heparan-N-sulfatase
|
| Therapeutic area |
Neurology
|
| Decision number |
P/0027/2015
|
| PIP number |
EMEA-001634-PIP01-14
|
| Pharmaceutical form(s) |
Solution for injection/infusion
|
| Condition(s) / indication(s) |
Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)
|
| Route(s) of administration |
Intrathecal use
|
| Contact for public enquiries |
Shire Human Genetic Therapies AB
|
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Decision
-
List item
Public summary of the evaluation of a proposed paediatric investigation plan: Recombinant human heparan N-sulfatase (rhHNS) for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo syndrome type A) (PDF/81.86 KB)
First published: 10/03/2015
Last updated: 10/03/2015
EMA/779395/2014 -
List item
Recombinant human heparan-N-sulfatase (rhHNS, SHP610, HGT-1410, Sulfamidase, San-A) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/92.74 KB)
First published: 14/06/2022