Intravenous nicardipine medicines
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
European Medicines Agency gives recommendations on the use of intravenous nicardipine
On 24 October 2013, the European Medicines Agency completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines. The Agency's Committee on Medicinal Products for Human Use (CHMP) concluded that these medicines should only be used to treat acute (sudden) life-threatening high blood pressure and to control high blood pressure after an operation. Use of intravenous nicardipine medicines in other indications is no longer recommended.
The CHMP also recommended that these medicines should only be given by continuous infusion (drip) into a vein by a specialist in a hospital or intensive care unit.
Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.
The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine. The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications. It also noted that medicines containing nicardipine given intravenously had been authorised in other EU countries but that the authorised uses differed between countries. The MHRA therefore decided to request an EU-wide review of these medicines.
Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.
The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 20 December 2013.
Key facts
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About this medicine
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|---|---|
| Approved name |
Intravenous nicardipine medicines
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| International non-proprietary name (INN) or common name |
nicardipine
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| Associated names |
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| Class |
Antihypertensive
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1339
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| Type | |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
24/10/2013
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| EC decision date |
20/12/2013
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Medicines Agency gives recommendations on the use of intravenous nicardipine (PDF/75.74 KB)
First published: 25/10/2013
Last updated: 25/10/2013
EMA/644174/2013
Nicardipine Article-31 referral - Annex III (PDF/93.39 KB)
First published: 25/10/2013
Last updated: 12/03/2014
Rev. 2
European Commission final decision
Nicardipine Article-31 referral - Assessment report (PDF/165.83 KB)
First published: 12/03/2014
Last updated: 12/03/2014
EMA/711459/2013
Nicardipine Article-31 referral - Annex I (PDF/45.05 KB)
First published: 12/03/2014
Last updated: 12/03/2014
Nicardipine Article-31 referral - Annex II (PDF/41.1 KB)
First published: 12/03/2014
Last updated: 12/03/2014
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.