Reason for request

Extension of indication

No clinical benefit demonstrated in paediatric patients, by comparison with its comparators, in the reduction of elevated intraocular pressure

   

  • TRAVATAN now has Marketing Authorisation in the reduction of elevated intraocular pressure (IOP), from 2 months of age, in paediatric patients with intraocular hypertension or glaucoma.
  • A study has demonstrated its non-inferiority relative to timolol after 12 weeks of treatment on the reduction of IOP in children.
  • No long-term safety data are available.
  • TRAVATAN contains excipients that may cause a skin reaction.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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