Norvasc - referral

Current status

European Commission final decision

Overview

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

What is Norvasc?

Norvasc is medicine that contains the active substance amlodipine. It has been used to treat cardiovascular problems such as hypertension (high blood pressure) and angina (chest pain caused by problems with the blood flow to the heart).

Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium particles normally enter. When calcium enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure for patients with hypertension and helping to make it easier for patients with heart problems to pump blood around the body.

Norvasc is also available in the EU under other trade names: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, and Norvasc.

The company that markets these medicines is Pfizer.

Why was Norvasc reviewed?

Norvasc 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.

On 2 February 2011, Pfizer referred the matter to the CHMP in order to harmonise the SmPCs as well as to standardise the test used for examining the quality of Norvasc 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

Norvasc had been used to treat hypertension and angina in all EU countries. A type of angina called vasospastic or Prinzmetal's angina was approved in all EU countries except Denmark, while coronary artery disease was approved in Latvia and Romania.

The CHMP harmonised the indications, recommending that Norvasc be used for: hypertension, chronic stable angina and vasospastic or Prinzmetal's angina.

4.2 Posology and method of administration

Dosing instructions were already harmonised in all EU countries, however, not all countries had dosing recommendations for Norvasc when used together with other medicines.

The CHMP has recommended that no dose adjustments for Norvasc are required when used together with the following antihypertensive medicines: thiazide, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors.

4.3 Contra-indications

The CHMP harmonised the contraindication as follows: hypersensitivity (allergy) to dihydropyridine derivatives, amlodipine or to any of the excipients; severe hypotension (low blood pressure), shock (a steep fall in blood pressure), obstruction of the outflow tract of the left ventricle (a chamber in the heart) and patients with heart failure following a heart attack.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.5 (interaction with other medicinal products and other forms of interaction) and 5.1 (pharmacodynamic properties).

The amended information to doctors and patients is available under the 'All documents' tab.

European Commission issued a decision on 7 October 2011.

Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules)

Adopted Reference Number: EMA/CHMP/583222/2011

Key facts

About this medicine

• Approved name:
  Norvasc
• International non-proprietary name (INN) or common name:
  amlodipine
• Associated names:
  • Amlodipine Pfizer
  • Amlodipino
  • Amlor
  • Istin
  • Monopina

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1288
• 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:
  21/07/2011
• EC decision date:
  07/10/2011

All documents

Norvasc - Article 30 referral - Assessment Report

Adopted

Norvasc - Article 30 referral - Annex I

Norvasc - Article 30 referral - Annex II

Norvasc - Article 30 referral - Annex III

Adopted

Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules)

Adopted Reference Number: EMA/CHMP/583222/2011

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.