Reassessment of reimbursement status for 5 combination products in ATC groups C07, C08 and C09

27 November 2008

The Danish Medicines Agency has assessed the question of the future reimbursement status for five combination products in ATC groups C07, C08 and C09 on the basis of updated information about prices and consumption of these medicinal products.
On this basis, we are considering a change of reimbursement status, entailing that medicinal products containing the following combinations should no longer be eligible for general reimbursement:

  • C07FB02: Metoprolol and felodipine
  • C08DA51: Verapamil and trandolapril
  • C09BA01: Captopril and hydrochlorothiazide
  • C09BA02: Enalapril 20 mg and hydrochlorothiazide 6 mg
  • C09BB: Perindopril and amlodipine

Consultation
Companies holding marketing authorisations for the medicinal products concerned have been asked to submit any comments to the assessment.
The consultation letters of 24 November 2008 and appendix I to these letters can be downloaded from the factbox to the right. The consultation deadline is Thursday 11 December 2008.

Any relevant stakeholders will be informed
A notification about the Danish Medicines Agency’s assessment has also been sent to the Danish Society of Cardiology, Danish Endocrine Society, Danish Hypertension Society, Danish Society for Vascular Surgery, Danish Surgical Society, Danish Medical Society, Danish Society of Nephrology, Danish Paediatric Society, Danish College of General Practitioners, Danish Stroke Society, Danish Society of Geriatrics, Danish Society of Internal Medicine, Danish Society of Clinical Pharmacology, Danish Patients and Disabled Peoples Organisations Denmark. In addition, the Danish National Board of Health, the Institute for Rational Pharmacotherapy and the Reimbursement Committee have been notified.

For further information, please contact the Reimbursement Department at medicintilskud@dkma.dk.

Danish Medicines Agency, 25 November 2008

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