Xalatan

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The Marketing Authorisation Holder (MAH) Pfizer Ltd submitted on 16 April 2010 an application for a new paediatric indication for Xalatan and associated names, in accordance with Article 29 of Regulation (EC) No 1901/2006 as amended.

The eligibility to the procedure was agreed upon by the EMA/CHMP on 24 September 2009.

The MAH applied for the following new therapeutic indication: Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.

Information on Paediatric requirements

Pursuant to Article 8 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/220/2009 for the following condition(s):

  • Reduction of elevated intraocular pressure in the treatment of paediatric glaucoma
    on an agreed paediatric investigation plan (PIP).

The PIP is completed.

The PDCO issued an opinion on compliance.

Licensing status

Xalatan and associated names has been given a Marketing Authorisation in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom, as well as in Iceland and Norway.

Key facts

Approved name
Xalatan
International non-proprietary name (INN) or common name
latanoprost
Associated names
  • Latanoprost Pharmacia & Upjohn
  • Xalatan 50 mikrogramov/ml kaplijice za oko, raztopina
Reference number
EMEA/H/A-29 PAE/1270
Type
Article 29 paediatrics

This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.

Status
European Commission final decision
Opinion date
22/07/2010
EC decision date
15/10/2010

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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