Paclitaxel Hetero and associated names - referral

Current status
European Commission final decision
ReferralHuman
  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Overview

On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).

Paclitaxel Hetero is a medicine that contains the active substance paclitaxel. It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi’s sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).

Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes’. It blocks the ability of cancer cells to break down their internal ‘skeleton’ that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die.

Paclitaxel Hetero was developed as a generic medicine. This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine’ already authorised in EU called Taxol.

The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.

Hetero Europe S.L. Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States’, in this instance Germany, the Netherlands and the UK).

However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.

The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent’ to Taxol. 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. In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles. Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.

Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent’ to Taxol and that their active substances behave in the same way in the body.

The Agency therefore concluded that the benefits of Paclitaxel Hetero do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.

The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.

The review was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.

The European Commission issued an EU-wide legally binding decision on 11 January 2019.

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Key facts

About this medicine

Approved name
Paclitaxel Hetero and associated names
International non-proprietary name (INN) or common name
paclitaxel

About this procedure

Current status
European Commission final decision
Reference number
EMEA/H/A-29(4)/1466
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)

Key dates and outcomes

CHMP opinion date
18/10/2018
EC decision date
11/01/2019

All documents

Opinion provided by Committee for Medicinal Products for human Use

български (BG) (95.29 KB - PDF)

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español (ES) (68.82 KB - PDF)

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čeština (CS) (91.86 KB - PDF)

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dansk (DA) (68.21 KB - PDF)

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Deutsch (DE) (69.88 KB - PDF)

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eesti keel (ET) (67.78 KB - PDF)

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ελληνικά (EL) (98.18 KB - PDF)

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français (FR) (69.23 KB - PDF)

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hrvatski (HR) (84.14 KB - PDF)

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italiano (IT) (68.25 KB - PDF)

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latviešu valoda (LV) (90.7 KB - PDF)

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lietuvių kalba (LT) (91.39 KB - PDF)

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magyar (HU) (84.56 KB - PDF)

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Malti (MT) (90.8 KB - PDF)

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Nederlands (NL) (68.68 KB - PDF)

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polski (PL) (91.52 KB - PDF)

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português (PT) (69.19 KB - PDF)

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română (RO) (89.78 KB - PDF)

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slovenčina (SK) (91.11 KB - PDF)

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slovenščina (SL) (86.02 KB - PDF)

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Suomi (FI) (68.12 KB - PDF)

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svenska (SV) (68.57 KB - PDF)

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European Commission final decision

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čeština (CS) (68.48 KB - PDF)

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dansk (DA) (38.23 KB - PDF)

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Deutsch (DE) (39.9 KB - PDF)

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eesti keel (ET) (37.74 KB - PDF)

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ελληνικά (EL) (74.54 KB - PDF)

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français (FR) (39.04 KB - PDF)

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hrvatski (HR) (65.06 KB - PDF)

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italiano (IT) (38.63 KB - PDF)

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latviešu valoda (LV) (69.15 KB - PDF)

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lietuvių kalba (LT) (68.79 KB - PDF)

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magyar (HU) (55.97 KB - PDF)

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Malti (MT) (70.34 KB - PDF)

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Nederlands (NL) (38.05 KB - PDF)

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polski (PL) (57.63 KB - PDF)

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português (PT) (38.78 KB - PDF)

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română (RO) (68.1 KB - PDF)

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slovenčina (SK) (68.12 KB - PDF)

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slovenščina (SL) (72.22 KB - PDF)

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Suomi (FI) (38 KB - PDF)

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svenska (SV) (38.41 KB - PDF)

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български (BG) (58.85 KB - PDF)

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español (ES) (26.11 KB - PDF)

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čeština (CS) (53.55 KB - PDF)

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dansk (DA) (27.7 KB - PDF)

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Deutsch (DE) (26.44 KB - PDF)

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eesti keel (ET) (25.71 KB - PDF)

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ελληνικά (EL) (61.55 KB - PDF)

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français (FR) (27.88 KB - PDF)

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hrvatski (HR) (51.18 KB - PDF)

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italiano (IT) (26.61 KB - PDF)

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latviešu valoda (LV) (53.3 KB - PDF)

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lietuvių kalba (LT) (56.16 KB - PDF)

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magyar (HU) (29.97 KB - PDF)

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Malti (MT) (56.43 KB - PDF)

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Nederlands (NL) (28.29 KB - PDF)

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polski (PL) (52.34 KB - PDF)

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português (PT) (27.96 KB - PDF)

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română (RO) (53.67 KB - PDF)

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slovenčina (SK) (52.75 KB - PDF)

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slovenščina (SL) (50.91 KB - PDF)

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Suomi (FI) (27.55 KB - PDF)

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svenska (SV) (26.18 KB - PDF)

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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.

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