New Harmonised SmPCs For 'Cozaar'(R) And 'Cozaar'(R)-Comp Implemented In The U.K. Following European Commission Decision

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals;  Diabetes
Article Date: 03 Jun 2009 - 5:00 PDT

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Merck Sharp & Dohme Limited (MSD) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented the harmonised Summary of Product Characteristics (SmPCs) for 'Cozaar'® (losartan potassium) and 'Cozaar'®-Comp (losartan potassium/ hydrochlorothiazide) into the U.K. Marketing Authorisation following a European Commission (EC) Decision.

'Cozaar' will be the first angiotensin receptor blocker (ARB) to come off patent and is now the only ARB to have four indications. The indications in the new harmonised SmPC are:

- Treatment of essential hypertension
- Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment
- Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure
- Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG

For 'Cozaar'-Comp, the indication is for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or HCTZ alone.

The sections of the SmPCs describing the safety profile of the medicines have also been harmonised and are in line with 'The Rules Governing Medicinal Products in the European Union' issued by the EC. Please visit emc.medicines.org.uk to access the full revised SmPCs.

The EC Decision aligned SmPCs across the 27 member states of the European Union, and was based on a consensus reached by European Regulators on the product information.*

Harmonisation process

Historically countries within the European Union have had varying local regulations and differing interpretations of data by the individual country regulatory body. Therefore, Marketing Authorisations registered on a national basis, like losartan, have varied. Regulations across Europe are becoming increasingly standardised and new medicine licensing processes are most commonly happening at an EU wide level.

The first step for the harmonisation is for the Coordination Group for Mutual Recognition and Decentralised Process (CMD(h)) to select the product (e.g. losartan) or class of products, and assess the differences in the SmPCs across EU countries. The group then requests the initiation of the referral process by the Committee for Medicinal Products for Human Use (CHMP).

The CHMP engage with the pharmaceutical company, in this case Merck & Co Inc., to discuss their proposal for labelling and supporting data, and when the Regulators reach a consensus at a European level on the SmPCs, they give their CHMP Opinion.

The Opinion is formalised by a Commission Decision from the EC, which national Agencies are obligated to implement into their national Marketing Authorisations. As of today, the MHRA have completed the implementation for losartan and losartan potassium/HCTZ in the U.K.

Hereafter the Marketing Authorisation is managed through harmonised EU variation procedures so that the same SmPC is retained.

Source
Merck Sharp & Dohme

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