Vascace Plus - referral

Current status

European Commission final decision

Overview

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

What is Vascace Plus?

Vascace Plus is a medicine that contains the active substances cilazapril and hydrochlorothiazide. It is used to treat hypertension (high blood pressure).

Cilazapril is an 'angiotensin converting enzyme (ACE) inhibitor'. It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the production of this hormone, cilazapril allows the blood vessels to widen, thereby reducing blood pressure.

Hydrochlorothiazide is a diuretic. It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure. The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.

Vascace Plus is also available in the EU under other trade names: Co-Inhibace, Dynorm Plus, Inhibace Plus and Inibace Plus.

The company that markets these medicines is F. Hoffmann – La Roche Ltd.

Why was Vascace Plus reviewed?

Vascace Plus 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.

Vascace Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 20 November 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace Plus 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

The CHMP recommended that Vascace Plus should be used for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone.

4.2 Posology and method of administration

The recommended dosage of Vascace Plus is one tablet administered once daily.

4.3 Contra-indications

Vascace Plus should not be used in patients who are hypersensitive (allergic) to cilazapril or other ACE inhibitors, hydrochlorothiazide or other thiazides diuretics, or to any other ingredients of the medicine. It must not be used in patients with a history of angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor, in patients with hereditary or idiopathic angioedema or in patients with kidney impairment or anuria (a condition in which a patient cannot make or pass urine). It must also not be used in the second and third trimesters (the last six months) of pregnancy.

Other sections

Other sections of the prescribing information such as those on special warnings, interactions with other medicines, and pregnancy and lactation and side effects were also harmonised.

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

Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)

Reference Number: EMA/652293/2010

Key facts

About this medicine

• Approved name:
  Vascace Plus
• International non-proprietary name (INN) or common name:
  • cilazapril
  • hydrochlorothiazide
• Associated names:
  • Co-Inhibace
  • Dynorm Plus
  • Inhibace Plus

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001153
• 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:
  21/10/2010
• EC decision date:
  21/01/2011

All documents

Vascace Plus - Article 30 referral - Assessment report

AdoptedReference Number: EMA/110390/2011

Vascace Plus - Article 30 referral - Annex I

Adopted

Vascace Plus - Article 30 referral - Annex II

Adopted

Vascace Plus - Article 30 referral - Annex III

Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)

Reference Number: EMA/652293/2010

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.