Cinacalcet Accordpharma

Authorised

This medicine is authorised for use in the European Union

cinacalcet

Overview

Cinacalcet Accordpharma is a medicine used to treat:

• secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products);
• hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.

In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition (serious kidney disease) while ‘primary’ means there is no other cause.

Cinacalcet Accordpharma contains the active substance cinacalcet and is a ‘generic medicine’. This means that Cinacalcet Accordpharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Mimpara.

How is Cinacalcet Accordpharma used?

Cinacalcet Accordpharma is available as 30, 60 and 90 mg tablets, to be taken with food or shortly after a meal.

In patients with secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day, while in children the daily starting dose depends on the child’s weight. The dose is adjusted, according to the patient’s PTH and calcium levels. In younger patients requiring less than 30 mg once a day, other cinacalcet products should be used that allow a lower dose to be given.

In patients with hypercalcaemia who also have parathyroid gland cancer or primary hyperparathyroidism, the recommended starting dose of Cinacalcet Accordpharma in adults is 30 mg twice a day. The dose should be increased every 2 to 4 weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.

The medicine can only be obtained with a prescription. For more information about using Cinacalcet Accordpharma, see the package leaflet or contact your doctor or pharmacist.

How does Cinacalcet Accordpharma work?

The active substance in Cinacalcet Accordpharma, cinacalcet, works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.

How has Cinacalcet Accordpharma been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Mimpara, and do not need to be repeated for Cinacalcet Accordpharma.  

As for every medicine, the company provided studies on the quality of Cinacalcet Accordpharma. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Cinacalcet Accordpharma?

Because Cinacalcet Accordpharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Cinacalcet Accordpharma authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Cinacalcet Accordpharma has been shown to have comparable quality and to be bioequivalent to Mimpara. Therefore, the Agency’s view was that, as for Mimpara, the benefits of Cinacalcet Accordpharma outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Cinacalcet Accordpharma?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinacalcet Accordpharma have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cinacalcet Accordpharma are continuously monitored. Side effects reported with Cinacalcet Accordpharma are carefully evaluated and any necessary action taken to protect patients.

Other information about Cinacalcet Accordpharma

Cinacalcet Accordpharma received a marketing authorisation valid throughout the EU on 3 April 2020.

Information on the reference medicine can also be found on the Agency’s website.

Cinacalcet Accordpharma : EPAR - Medicine overview

Reference Number: EMA/65298/2020

Cinacalcet Accordpharma : EPAR - Risk management plan

Product information

Cinacalcet Accordpharma : EPAR - Product information

Latest procedure affecting product information: IB/0009

15/05/2023

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Cinacalcet Accordpharma : EPAR - All authorised presentations

Product details

• Name of medicine:
  Cinacalcet Accordpharma
• Active substance:
  cinacalcet hydrochloride
• International non-proprietary name (INN) or common name:
  cinacalcet
• Therapeutic area (MeSH):
  Hyperparathyroidism
• Anatomical therapeutic chemical (ATC) code:
  H05BX01

Pharmacotherapeutic group

Calcium homeostasis

Therapeutic indication

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005236
• 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.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  30/01/2020
• Marketing authorisation issued:
  03/04/2020
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Cinacalcet Accordpharma : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Cinacalcet Accordpharma : EPAR - Public assessment report

AdoptedReference Number: EMA/92635/2020

CHMP summary of positive opinion for Cinacalcet Accordpharma

AdoptedReference Number: EMA/43762/2020