Uman Big - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ml, solution for injection. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Uman Big outweigh its risks, and that the marketing authorisation granted in Italy can be recognised in other Member States of the European Union and the European Economic Area.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 06 March 2009.

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Uman Big?

Uman Big is a solution of human hepatitis B immunoglobulins. Immunoglobulins are blood proteins that have been extracted from donor plasma. Hepatitis B immunoglobulins contain high levels of antibodies against the hepatitis B virus. Uman Big is given as an intramuscular (into the muscle) injection to prevent hepatitis B in the following cases:

• in case of accidental exposure in people who have not been vaccinated against the hepatitis B virus; including those whose vaccination is incomplete or status unknown;
• in haemodialysed patients (patients whose kidneys have failed and who rely on a blood purification technique called haemodialysis), until vaccination has become effective;
• in the newborn of a hepatitis B virus carrier-mother;
• in subjects who did not show an immune response after vaccination (and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.

Why was Uman Big reviewed?

Kedrion S.p.A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979. The company wanted the authorisation to be recognised in Austria, Denmark, Germany, Greece, Hungary, Poland, Portugal and Sweden (the concerned Member States). These member states were not able to reach an agreement. On 31 October 2008, the Italian medicines agency, Agenzia Italiana del Farmaco, referred the matter to the CHMP.

The grounds for the referral were concerns over the insufficiency of the clinical data submitted to establish the efficacy of the product. In addition, the absence of product specific safety data or post-marketing safety data was raised as a concern.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP's Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states.

Questions and answers on the referral for Uman Big Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection

Adopted Reference Number: EMEA/CHMP/173455/2009

Key facts

About this medicine

• Approved name:
  Uman Big
• International non-proprietary name (INN) or common name:
  human hepatitis B immunoglobulin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/173455/2009
• 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:
  19/12/2008
• EC decision date:
  06/03/2009

All documents

Uman Big - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Uman Big Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection

Adopted Reference Number: EMEA/CHMP/173455/2009

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.