Xalatan - referral

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.

Xalatan - Article 29 paediatrics - CHMP assessment report

Reference Number: EMA/531707/2010

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  22/07/2010
• EC decision date:
  15/10/2010

All documents

Xalatan - Article 29 paediatrics - Annexes I, II, III

Opinion provided by Committee for Medicinal Products for human Use

Xalatan - Article 29 paediatrics - CHMP assessment report

Reference Number: EMA/531707/2010

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.