Norvasc

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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.

Name Language First published Last updated
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) BG = bălgarski 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) ES = español 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) CS = čeština 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) DA = dansk 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) DE = Deutsch 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) ET = eesti keel 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) EL = elliniká 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) EN = English 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) FR = français 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) IT = italiano 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) LV = latviešu valoda 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) LT = lietuvių kalba 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) HU = magyar 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) MT = Malti 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) NL = Nederlands 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) PL = polski 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) PT = português 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) RO = română 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SK = slovenčina 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SL = slovenščina 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) FI = suomi 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SV = svenska 2011-07-22 2012-03-29

Key facts

Approved nameNorvasc
International non-proprietary name (INN) or common name

amlodipine

Associated namesAmlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina
Class
Reference numberEMEA/H/A-30/1288
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date21/07/2011

All documents

Name Language First published Last updated
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) BG = bălgarski 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) ES = español 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) CS = čeština 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) DA = dansk 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) DE = Deutsch 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) ET = eesti keel 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) EL = elliniká 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) EN = English 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) FR = français 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) IT = italiano 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) LV = latviešu valoda 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) LT = lietuvių kalba 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) HU = magyar 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) MT = Malti 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) NL = Nederlands 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) PL = polski 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) PT = português 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) RO = română 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SK = slovenčina 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SL = slovenščina 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) FI = suomi 2011-07-22 2012-03-29
Questions and answers on Norvasc and associated names (amlodipine, 5 and 10 mg tablets and capsules) SV = svenska 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Assessment Report (English only) 2012-03-29  
Norvasc - Article 30 referral - Annex I BG = bălgarski 2012-03-29  
Norvasc - Article 30 referral - Annex I ES = español 2012-03-29  
Norvasc - Article 30 referral - Annex I CS = čeština 2012-03-29  
Norvasc - Article 30 referral - Annex I DA = dansk 2012-03-29  
Norvasc - Article 30 referral - Annex I DE = Deutsch 2012-03-29  
Norvasc - Article 30 referral - Annex I ET = eesti keel 2012-03-29  
Norvasc - Article 30 referral - Annex I EL = elliniká 2012-03-29  
Norvasc - Article 30 referral - Annex I EN = English 2012-03-29  
Norvasc - Article 30 referral - Annex I FR = français 2012-03-29  
Norvasc - Article 30 referral - Annex I IT = italiano 2012-03-29  
Norvasc - Article 30 referral - Annex I LV = latviešu valoda 2012-03-29  
Norvasc - Article 30 referral - Annex I LT = lietuvių kalba 2012-03-29  
Norvasc - Article 30 referral - Annex I HU = magyar 2012-03-29  
Norvasc - Article 30 referral - Annex I MT = Malti 2012-03-29  
Norvasc - Article 30 referral - Annex I NL = Nederlands 2012-03-29  
Norvasc - Article 30 referral - Annex I PL = polski 2012-03-29  
Norvasc - Article 30 referral - Annex I PT = português 2012-03-29  
Norvasc - Article 30 referral - Annex I RO = română 2012-03-29  
Norvasc - Article 30 referral - Annex I SK = slovenčina 2012-03-29  
Norvasc - Article 30 referral - Annex I SL = slovenščina 2012-03-29  
Norvasc - Article 30 referral - Annex I FI = suomi 2012-03-29  
Norvasc - Article 30 referral - Annex I SV = svenska 2012-03-29  
Norvasc - Article 30 referral - Annex II BG = bălgarski 2012-03-29  
Norvasc - Article 30 referral - Annex II ES = español 2012-03-29  
Norvasc - Article 30 referral - Annex II CS = čeština 2012-03-29  
Norvasc - Article 30 referral - Annex II DA = dansk 2012-03-29  
Norvasc - Article 30 referral - Annex II DE = Deutsch 2012-03-29  
Norvasc - Article 30 referral - Annex II ET = eesti keel 2012-03-29  
Norvasc - Article 30 referral - Annex II EL = elliniká 2012-03-29  
Norvasc - Article 30 referral - Annex II EN = English 2012-03-29  
Norvasc - Article 30 referral - Annex II FR = français 2012-03-29  
Norvasc - Article 30 referral - Annex II IT = italiano 2012-03-29  
Norvasc - Article 30 referral - Annex II LV = latviešu valoda 2012-03-29  
Norvasc - Article 30 referral - Annex II LT = lietuvių kalba 2012-03-29  
Norvasc - Article 30 referral - Annex II HU = magyar 2012-03-29  
Norvasc - Article 30 referral - Annex II MT = Malti 2012-03-29  
Norvasc - Article 30 referral - Annex II NL = Nederlands 2012-03-29  
Norvasc - Article 30 referral - Annex II PL = polski 2012-03-29  
Norvasc - Article 30 referral - Annex II PT = português 2012-03-29  
Norvasc - Article 30 referral - Annex II RO = română 2012-03-29  
Norvasc - Article 30 referral - Annex II SK = slovenčina 2012-03-29  
Norvasc - Article 30 referral - Annex II SL = slovenščina 2012-03-29  
Norvasc - Article 30 referral - Annex II FI = suomi 2012-03-29  
Norvasc - Article 30 referral - Annex II SV = svenska 2012-03-29  
Norvasc - Article 30 referral - Annex III BG = bălgarski 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III ES = español 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III CS = čeština 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III DA = dansk 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III DE = Deutsch 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III ET = eesti keel 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III EL = elliniká 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III EN = English 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III FR = français 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III IT = italiano 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III LV = latviešu valoda 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III LT = lietuvių kalba 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III HU = magyar 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III MT = Malti 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III NL = Nederlands 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III PL = polski 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III PT = português 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III RO = română 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III SK = slovenčina 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III SL = slovenščina 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III FI = suomi 2011-07-22 2012-03-29
Norvasc - Article 30 referral - Annex III SV = svenska 2011-07-22 2012-03-29

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision