🇪🇺 Tafluprost, timolol maleate in European Union

EMA authorised Tafluprost, timolol maleate on 20 February 2014

Marketing authorisation

EMA — authorised 20 February 2014

  • Application: EMEA/H/C/002738
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Izba
  • Indication: Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.
  • Status: approved

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Tafluprost, timolol maleate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Tafluprost, timolol maleate approved in European Union?

Yes. EMA authorised it on 20 February 2014.

Who is the marketing authorisation holder for Tafluprost, timolol maleate in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.