Atacand Plus - referral

Current status

European Commission final decision

Overview

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

What is Atacand Plus?

Atacand Plus is a medicine that contains two active substances candesartan cilexetil and hydrochlorothiazide. It is used to treat essential hypertension (high blood pressure). 'Essential' means that the hypertension has no obvious cause.

Candesartan is an 'angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, candesartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to fall.

Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure. The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.

Atacand Plus is also available in the EU under other trade names: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus and Ratacand Plus.

The companies that market these medicines are AstraZeneca and Takeda.

Why was Atacand Plus reviewed?

Atacand 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.

Atacand Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)). On 27 October 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand 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 Atacand Plus be used to treat essential hypertension in adults whose blood pressure is not optimally controlled by candesartan cilexetil or hydrochlorothiazide alone.

4.2 Posology and method of administration
Atacand Plus should be taken at a dose of one tablet once a day. Dose titration is recommended. This means that the doctor should try different tablet strengths until the strength that adequately controls the patient's blood pressure is found.

4.3 Contra-indications
Atacand Plus must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients or to substances derived from sulfonamide. It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe kidney or liver problems, cholestasis (problems with the elimination of bile), gout (a painful inflammation of the joints) and hypokalaemia (low blood potassium levels) or hypercalcaemia (high blood calcium levels).

Other changes
The Committee also harmonised other sections of the SmPC including sections on special warnings, interactions with other medicines and pregnancy and lactation.

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

The European Commission issued a decision on 16 September 2010.

Questions and answers on Atacand Plus and associated names (candesartan cilexetil/hydrochlorothiazide tablets 8/12.5 mg, 16/12.5 mg, 32/12.5 mg and 32/25 mg)

Reference Number: EMEA/H/A-30/001152

Key facts

About this medicine

• Approved name:
  Atacand Plus
• International non-proprietary name (INN) or common name:
  • candesartan
  • hydrochlorothiazide
• Associated names:
  • Atacand Zid
  • Blopresid
  • Blopress Comp
  • Blopress Plus
  • CoKenzen
  • Hytacand
  • Parapres Plus
  • Ratacand Plus

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001152
• 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:
  24/06/2010
• EC decision date:
  16/09/2010

All documents

Atacand plus - Article 30 referral - Annex I

Adopted

Atacand plus - Article 30 referral - Annex II

Adopted

Atacand Plus - Article 30 referral - Annex III

Questions and answers on Atacand Plus and associated names (candesartan cilexetil/hydrochlorothiazide tablets 8/12.5 mg, 16/12.5 mg, 32/12.5 mg and 32/25 mg)

Reference Number: EMEA/H/A-30/001152

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.