Sandostatin LAR and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
On 26 June 2014, the European Medicines Agency completed a review of Sandostatin LAR. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandostatin LAR in the European Union (EU).
Key facts
Approved name |
Sandostatin LAR and associated names
|
International non-proprietary name (INN) or common name |
octreotide |
Reference number |
EMEA/H/A-30/001355
|
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. |
Status |
European Commission final decision
|
Opinion date |
26/06/2014
|
EC decision date |
26/06/2014
|
All documents
-
List item
Questions and answers on Sandostatin LAR and associated names (octreotide, 10, 20 and 30 mg powder and solvent for suspension for injection) (PDF/82.32 KB)
First published: 27/06/2014
Last updated: 27/06/2014
EMA/376450/2014 -
List item
Sandostatin LAR - Article 30 referral - Annex III (PDF/172.76 KB)
First published: 27/06/2014
Last updated: 02/07/2014
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