Sandostatin and associated names - referral

Current status

European Commission final decision

Overview

On 26 June 2014, the European Medicines Agency completed a review of Sandostatin. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandostatin in the European Union (EU).

What is Sandostatin?

Sandostatin is a medicine that contains the active substance octreotide. Octreotide is a synthetic substance that mimics the activity of the natural hormone somatostatin. Like somatostatin, octreotide blocks the release of hormones found in the body, particularly growth hormone (which consequently reduces the release of insulin-like growth factor 1, IGF-1) but also others such as thyroid-stimulating hormone (TSH) and various gut hormones.

Sandostatin has been authorised in the EU since the 1980s for treating various conditions, including acromegaly (a disease in which the pituitary gland produces too much growth hormone, leading to excess growth of body tissues and organs), gastro-entero-pancreatic endocrine tumours (tumours that arise from cells in the gut which release hormones that control various functions of the digestive system), prevention of complications following pancreatic surgery, and bleeding gastro-oesophageal varices (enlarged veins in the oesophagus or stomach that bleed).

Sandostatin is available as a solution to be injected under the skin or to be diluted before giving it by infusion (drip) into a vein. The medicine is marketed in all the EU Member States.

The company that markets these medicines is Novartis.

Why was Sandostatin reviewed?

Sandostatin is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Sandostatin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 22 May 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandostatin in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the medicine's use, the CHMP agreed that Sandostatin should continue to be used for the following conditions:

• Symptomatic control and reduction of growth hormone and IGF?1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin is also indicated for patients with acromegaly who are unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.
• Relief of symptoms associated with functional gastro?entero?pancreatic endocrine tumours. Sandostatin is not an anti?tumour therapy and is not curative in these patients.
• Prevention of complications following pancreatic surgery.
• Emergency management to stop bleeding and to protect from re?bleeding owing to gastro?oesophageal varices in patients with cirrhosis (scarring of the liver). Sandostatin is to be used in association with specific treatments such as endoscopic sclerotherapy.
• Treatment of TSH?secreting pituitary adenomas (benign tumours of the pituitary gland):
  • when secretion has not normalised after surgery and/or radiotherapy;
  • in patients in whom surgery is inappropriate;
  • in patients who have received radiotherapy, until the radiotherapy is effective.

However, Sandostatin should no longer be used to control diarrhoea associated with AIDS as initiation of HIV treatment is the current standard of care.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised recommendations on the doses and duration of treatment with Sandostatin.

4.3 Contraindications

The CHMP agreed that hypersensitivity (allergy) to octreotide or any other ingredients in Sandostatin should be the only contraindication.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (pregnancy and lactation) and 4.8 (side effects).

A European Commission decision on this opinion will be issued in due course.

Questions and answers on Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml, 0.5 mg/1 ml and 1 mg/5 ml, solution for injection or infusion)

Reference Number: EMA/376438/2014

Key facts

About this medicine

• Approved name:
  Sandostatin and associated names
• International non-proprietary name (INN) or common name:
  ocreotide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001354
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  26/06/2014
• EC decision date:
  26/06/2014

All documents

Opinion provided by Committee for Medicinal Products for human Use

Sandostatin - Article 30 referral - Annex III

Questions and answers on Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml, 0.5 mg/1 ml and 1 mg/5 ml, solution for injection or infusion)

Reference Number: EMA/376438/2014

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.