Daruph and Anafezyn
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 19 May 2022, the European Medicines Agency completed a review of Daruph/Anafezyn1 following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Daruph/Anafezyn outweigh its risks, and that the marketing authorisation should be granted in Sweden and in the Member States of the EU where the company applied for a marketing authorisation (France, Germany, Hungary, Ireland, Italy, Poland, Portugal, Romania and Slovakia).
1These medicines are identical and were submitted as part of a so called ‘duplicate application’. They are referred to as Daruph/Anafezyn in this document. Daruph/Anafezyn was also to be available in the EU under the trade name Dasatinib Zentiva.
Key facts
|
About this medicine
|
|
|---|---|
| Approved name |
Daruph and Anafezyn
|
| International non-proprietary name (INN) or common name |
dasatinib (anhydrous)
|
|
About this procedure
|
|
|---|---|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/H/A-29(4)/1516
|
| 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. |
| Authorisation model |
Nationally authorised product(s)
|
| Decision making model |
CHMP-EC
|
|
Key dates and outcomes
|
|
|---|---|
| CHMP opinion date |
19/05/2022
|
| EC decision date |
18/07/2022
|
All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Daruph and Anafezyn Article 29(4) referral - EMA recommends authorisation of Daruph / Anafezyn (dasatinib anhydrous) in the EU (PDF/123.84 KB)
First published: 09/08/2022
EMA/662970/2022
Daruph and Anafezyn Art 29(4) referral - Assessment report (PDF/324.96 KB)
First published: 22/07/2022
EMA/594862/2022
Daruph and Anafezyn Article 29(4) referral - Annex I (PDF/101.75 KB)
First published: 22/07/2022
Daruph and Anafezyn Article 29(4) referral - Annex II (PDF/91.94 KB)
First published: 22/07/2022
Daruph and Anafezyn Article 29(4) referral - Annex III (PDF/51.69 KB)
First published: 20/05/2022
Last updated: 22/07/2022
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.