EMEA-002435-PIP01-18

Key facts

Active substance
recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein
Therapeutic area
Neurology
Decision number
P/0310/2019
PIP number
EMEA-002435-PIP01-18
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of aromatic L-amino acid decarboxylase deficiency
Route(s) of administration
  • Intracerebral use
  • Intracerebroventricular use
  • Intracisternal use
  • Intrathecal use
Contact for public enquiries
PTC Therapeutics International Limited
Tel. +353 19068700
E-mail: medinfo@ptcbio.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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