Plendil and associated names - referral

Current status

European Commission final decision

Overview

On 23 October 2014, the European Medicines Agency completed a review of Plendil and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Plendil and associated names in the European Union (EU).

What is Plendil?

Plendil is a medicine used to treat hypertension (high blood pressure). It is also used to treat angina pectoris (chest pain that occurs due to problems with the blood flow to the heart). Plendil contains the active substance felodipine. The medicine is available as prolonged release tablets (2.5, 5 and 10 mg) which release the active substance over an extended period of time.

Plendil and associated names have been authorised in EU Member States through national procedures since 1987.

Plendil and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.

The company that markets these medicines is AstraZeneca.

Why was Plendil reviewed?

As Plendil has been 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 differences in the SmPCs (summary of product characteristics), labelling and package leaflets in the countries where the medicine is marketed.

In view of this, on 12 November 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Plendil 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 for Plendil should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the medicine's use, the CHMP agreed that Plendil can be used to treat the following:

• hypertension;
• stable angina pectoris (a type of angina pectoris that occurs with activity or stress).

The Committee also agreed that Plendil should no longer be recommended to treat 'vasospastic angina pectoris' (another type of angina pectoris caused by spasms in the vessels supplying blood to the heart), because the available data to support this use were considered too limited.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised recommendations on the doses and recommendations for special populations.

4.3 Contra-indications

The CHMP agreed to include the following contraindications in the product information: hypersensitivity (allergy) to felodipine or to any other ingredients; pregnancy; decompensated heart failure (worsening of symptoms in patients with heart problems); acute myocardial infarction (heart attack); unstable angina pectoris (a type of chest pain that happens suddenly, even at rest or asleep, and which may lead to a heart attack), and certain types of heart valve and bloodflow obstructions.

Other changes

The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects). The labelling and package leaflet were also revised in line with the changes to the SmPC.

The amended information to doctors and patients is available in Annex III under 'All Documents' tab.

The European Commission issued an EU-wide legally binding decision to implement these changes on 16 December 2014.

Questions and answers on Plendil and associated names (felodipine 2.5, 5 and 10 mg prolonged release tablets)

Reference Number: EMA/638615/2014

Key facts

About this medicine

• Approved name:
  Plendil and associated names
• International non-proprietary name (INN) or common name:
  felodipine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1385
• 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:
  23/10/2014
• EC decision date:
  16/12/2014

All documents

Opinion provided by Committee for Medicinal Products for human Use

Plendil - Article 30 referral - Annex III

Questions and answers on Plendil and associated names (felodipine 2.5, 5 and 10 mg prolonged release tablets)

Reference Number: EMA/638615/2014

European Commission final decision

Plendil - Article 30 referral - Assessment report

AdoptedReference Number: EMA/707004/2014

Plendil - Article 30 referral - Annex I

Plendil - Article 30 referral - Annex II

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.