Okrido - referral

Current status

European Commission final decision

Overview

On 27 June 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Okrido. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Okrido outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the European Union (EU).

What is Okrido?

Okrido is a medicine that contains the active substance prednisolone sodium phosphate. It is available as an oral solution (6 mg/ml).

The active substance in Okrido, prednisolone sodium phosphate, belongs to a group of medicines called glucocorticoids, which are substances that help to reduce inflammation.

Okrido is used to treat a range of inflammatory and auto-immune conditions (diseases caused by the body's own defence system attacking normal tissue) including:

• allergies, including severe allergic reactions;
• diseases of the lungs (including asthma), upper airways (croup), blood vessels and heart, bowel or kidneys, muscles and joints (including rheumatoid arthritis) or the eye or nervous system;
• skin conditions;
• some cancers, including leukaemia, lymphoma and myeloma;
• organ transplantation.

Okrido is a generic medicine based on a 'reference medicine' already authorised in the EU. The reference medicine was prednisolone 5-mg soluble tablets by Sovereign.

Why was Okrido reviewed?

Pharmapol Arzneimittelvertrieb GmbH submitted Okrido for mutual recognition on the basis of the initial authorisation granted by the United Kingdom's Medicines and Healthcare Products Regulatory Agency on 19 April 2010. The company wanted the authorisation to be recognised in Germany and the Netherlands (the 'concerned Member States'). However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 5 March 2013.

The grounds for the referral were that sufficient data had not been provided to show that Okrido produces comparable levels of the active substance in the body to prednisolone 5-mg soluble tablets by Sovereign. In particular, as the two medicines contain different excipients (inactive ingredients), the Netherlands considered that further studies were needed to show that these differences did not result in relevant differences in the way the two medicines are absorbed by the body.

What are the conclusions of the CHMP?

Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that, based on the data submitted, Okrido is expected to produce comparable levels of the active substance in the body to the reference medicine. The CHMP therefore concluded that the benefits of Okrido outweigh its risks, and therefore the marketing authorisation for Okrido should be granted in all concerned Member States.

The European Commission issued a decision on 5 September 2013.

Questions and answers on Okrido (prednisolone sodium phosphate, oral solution, 6 mg/ml)

Key facts

About this medicine

• Approved name:
  Okrido
• International non-proprietary name (INN) or common name:
  prednisolone sodium phosphate
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1368
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  27/06/2013
• EC decision date:
  05/09/2013

All documents

Opinion provided by Committee for Medicinal Products for human Use

Questions and answers on Okrido (prednisolone sodium phosphate, oral solution, 6 mg/ml)

European Commission final decision

Okrido Article-29 referral - CHMP assessment report

Adopted Reference Number: EMA/597619/2013

Okrido Article-29 referral - Annex I

Okrido Article-29 referral - Annex II

Okrido Article-29 referral - Annex III

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.