Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Docetaxel Mylan   
Auth. number : EU/1/11/748
INN : Docetaxel
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: L01CD02 - Docetaxel
(See WHO ATC Index)
Indication: Breast cancer
Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
- operable node positive breast cancer
- operable node negative breast cancer
For patients with operable node negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Docetaxel Mylan in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Docetaxel Mylan in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer
Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Docetaxel Mylan in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer
Docetaxel Mylan in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma
Docetaxel Mylan in combination with cisplatin and 5 fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer
Docetaxel Mylan in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Marketing Authorisation Holder: Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/02/2012 Centralised - Authorisation EMEA/H/C/2317 (2012)656 of 31/01/2012
23/05/2012 Centralised - Variation EMEA/H/C/2317/IB/1
Updated with Decision(2012)7929 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7929 of 29/10/2012
13/06/2013 Centralised - Variation EMEA/H/C/2317/IB/2
Updated with Decision(2014)3822 of 03/06/2014
18/11/2013 Centralised - Variation EMEA/H/C/2317/IB/3/G
Updated with Decision(2014)3822 of 03/06/2014
19/03/2014 Centralised - Variation EMEA/H/C/2317/IB/4
Updated with Decision(2014)3822 of 03/06/2014
05/06/2014 Centralised - Yearly update (2014)3822 of 03/06/2014
11/08/2014 Centralised - Variation EMEA/H/C/2317/IB/6