Cinacalcet Accordpharma

cinacalcet

Table of contents

Opinion

On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cinacalcet Accordpharma, intended for the treatment of secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism. The applicant for this medicinal product is Accord Healthcare S.L.U.

Cinacalcet Accordpharma will be available as 30-mg, 60-mg and 90-mg film-coated tablets for oral use. The active substance of Cinacalcet Accordpharma is cinacalcet, a calcimimetic agent (ATC code: H05BX01), which lowers parathyroid hormone levels by increasing the sensitivity of the calcium-sensing receptor in the parathyroid gland to extracellular calcium.

Cinacalcet Accordpharma is a generic of Mimpara, which has been authorised in the EU since 22 October 2004. Studies have demonstrated the satisfactory quality of Cinacalcet, and its bioequivalence to the reference product Mimpara. A question and answer document on generic medicines can be found here.

The full indication is:

Secondary hyperparathyroidism

Adults

Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Paediatric population

Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).

Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).

Parathyroid carcinoma and primary hyperparathyroidism in adults

Reduction of hypercalcaemia in adult patients with:

  • parathyroid carcinoma.
  • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Cinacalcet Accordpharma
Agency product number
EMEA/H/C/005236
International non-proprietary name (INN) or common name
  • cinacalcet
Active substance
  • cinacalcet hydrochloride
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
30/01/2020
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

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