Sandimmun Neoral and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).
Key facts
Approved name |
Sandimmun Neoral and associated names
|
International non-proprietary name (INN) or common name |
ciclosporin |
Reference number |
EMEA/H/A-30/1300, EMEA/H/A-30/1320
|
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 |
27/06/2013
|
EC decision date |
31/10/2013
|
All documents
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Questions and answers on Sandimmun, Sandimmun Neoral and associated names (ciclosporin, 10, 25, 50 and 100 mg capsules, 100 mg/ml oral solution and 50 mg/ml concentrate for solution for infusion) (PDF/77.04 KB)
First published: 28/06/2013
Last updated: 20/12/2013
EMA/391239/2013 -
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Sandimmun Neoral Article-30 referral - Assessment report (PDF/339.88 KB)
Adopted
First published: 30/01/2014
Last updated: 30/01/2014
EMA/589501/2013 -
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Sandimmun Neoral Article-30 referral - Annex I (PDF/594.81 KB)
First published: 20/12/2013
Last updated: 20/12/2013 -
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Sandimmun Neoral Article-30 referral - Annex II (PDF/179.17 KB)
First published: 20/12/2013
Last updated: 20/12/2013
EMEA/H/A-30/1300 -
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Sandimmun Neoral Article-30 referral - Annex III (PDF/1.25 MB)
First published: 28/06/2013
Last updated: 20/12/2013 -
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