Fortipan Combi D

Procedure started
Under evaluation
CHMP opinion
European Commission final decision

Overview
Key facts
All documents

Current status:

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Fortipan Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fortipan Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in Italy.

: Fortipan Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol (vitamin D3). It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol).

Fortipan Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. It is used to reduce the risk of fractures in the hip and the spine. The active substance in the tablets, risedronate sodium, is a bisphosphonate. It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.

: Warner Chilcott UK Ltd submitted Fortipan Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006. The company wanted the authorisation to be recognised in Italy (the 'concerned Member State').

However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.

The grounds for the referral were concerns over the evidence provided on the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).

: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fortipan Combi D outweigh its risks, and therefore that the marketing authorisation for Fortipan Combi D should be granted in the concerned Member State.

The European Commission issued a decision on 5 October 2010.

List item

Questions and answers on Fortipan Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules) (PDF/50.45 KB)

First published: 25/06/2010
Last updated: 13/09/2011
EMEA/H/A-29/1272
- Bulgarian
  (PDF/254.59 KB)
- Czech
  (PDF/207.82 KB)
- Danish
  (PDF/36.69 KB)
- Dutch
  (PDF/39 KB)
- Estonian
  (PDF/36.7 KB)
- Finnish
  (PDF/35.85 KB)
- French
  (PDF/38.65 KB)
- German
  (PDF/38.69 KB)
- Greek
  (PDF/250.09 KB)
- Hungarian
  (PDF/171.49 KB)
- Italian
  (PDF/37.2 KB)
- Latvian
  (PDF/213.34 KB)
- Lithuanian
  (PDF/148.26 KB)
- Maltese
  (PDF/179.43 KB)
- Polish
  (PDF/154.89 KB)
- Portuguese
  (PDF/99.23 KB)
- Romanian
  (PDF/172.23 KB)
- Slovak
  (PDF/206.96 KB)
- Slovenian
  (PDF/199.16 KB)
- Spanish
  (PDF/97.21 KB)
- Swedish
  (PDF/95.91 KB)

Key facts

Approved name	Fortipan Combi D
International non-proprietary name (INN) or common name	risedronate sodium / calcium carbonate plus colecalciferol
Associated names	Actocalcio D3 Acrelcombi
Reference number	EMEA/H/A-29/001272
Type	Article 29(4) referrals This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
Status	European Commission final decision
Opinion date	24/06/2010
EC decision date	05/10/2010

All documents

List item

Questions and answers on Fortipan Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules) (PDF/50.45 KB)

First published: 25/06/2010
Last updated: 13/09/2011
EMEA/H/A-29/1272
- Bulgarian
  (PDF/254.59 KB)
- Czech
  (PDF/207.82 KB)
- Danish
  (PDF/36.69 KB)
- Dutch
  (PDF/39 KB)
- Estonian
  (PDF/36.7 KB)
- Finnish
  (PDF/35.85 KB)
- French
  (PDF/38.65 KB)
- German
  (PDF/38.69 KB)
- Greek
  (PDF/250.09 KB)
- Hungarian
  (PDF/171.49 KB)
- Italian
  (PDF/37.2 KB)
- Latvian
  (PDF/213.34 KB)
- Lithuanian
  (PDF/148.26 KB)
- Maltese
  (PDF/179.43 KB)
- Polish
  (PDF/154.89 KB)
- Portuguese
  (PDF/99.23 KB)
- Romanian
  (PDF/172.23 KB)
- Slovak
  (PDF/206.96 KB)
- Slovenian
  (PDF/199.16 KB)
- Spanish
  (PDF/97.21 KB)
- Swedish
  (PDF/95.91 KB)
List item

Fortipan Combi D - Article 29 refferal - Annex I-III (PDF/43.7 KB)

First published: 13/09/2011
Last updated: 13/09/2011
- Bulgarian
  (PDF/189.5 KB)
- Czech
  (PDF/179.2 KB)
- Danish
  (PDF/40.08 KB)
- Dutch
  (PDF/40.28 KB)
- Estonian
  (PDF/41.46 KB)
- Finnish
  (PDF/42.33 KB)
- French
  (PDF/40.59 KB)
- German
  (PDF/42.66 KB)
- Greek
  (PDF/191.86 KB)
- Hungarian
  (PDF/112.42 KB)
- Italian
  (PDF/40.73 KB)
- Latvian
  (PDF/99.86 KB)
- Lithuanian
  (PDF/116.72 KB)
- Maltese
  (PDF/115.29 KB)
- Polish
  (PDF/114.42 KB)
- Portuguese
  (PDF/102.73 KB)
- Romanian
  (PDF/172.81 KB)
- Slovak
  (PDF/171.97 KB)
- Slovenian
  (PDF/93.27 KB)
- Spanish
  (PDF/102.01 KB)
- Swedish
  (PDF/41.9 KB)

Document description

Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
List of the medicines affected by the referral (Annex I)
Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating

★ ★ ★ ★ ★