Losec
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status
European Commission final decision
Overview
The European Medicines Agency has completed a review of Losec. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Losec and associated names in the European Union (EU).
Key facts
|
About this medicine
|
|
|---|---|
| Approved name |
Losec
|
| International non-proprietary name (INN) or common name |
omeprazole
|
| Associated names |
|
|
About this procedure
|
|
|---|---|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/H/A-30/1001
|
| 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 |
20/01/2010
|
| EC decision date |
10/06/2010
|
All documents
List item
Losec - Article 30 referral - Annex I (PDF/141.71 KB)
Adopted
First published: 19/09/2011
Last updated: 19/09/2011
First published: 19/09/2011
Last updated: 19/09/2011
List item
Losec - Article 30 referral - Annex II (PDF/149.82 KB)
Adopted
First published: 19/09/2011
Last updated: 19/09/2011
First published: 19/09/2011
Last updated: 19/09/2011
List item
Losec - Article 30 referral - Annex IV (PDF/122.33 KB)
Adopted
First published: 19/09/2011
Last updated: 19/09/2011
First published: 19/09/2011
Last updated: 19/09/2011
List item
Losec - Article 30 referrals - Annex III (PDF/711 KB)
Adopted
First published: 23/01/2010
Last updated: 20/09/2011
First published: 23/01/2010
Last updated: 20/09/2011
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.