Argentina - Drug Information Association

European Union - EMA EPAR EMEA/H/C/002032: DOCETAXEL TEVA PHARMA
(docetaxel)
Name of the medicinal product: DOCETAXEL TEVA PHARMA - International Nonproprietary Name: docetaxel - Marketing
Authorisation Holder: Teva Pharma B.V. - Pharmaco-therapeutic group - (ATC Code): Taxanes - (L01CD 02) - Therapeutic
indication(s): + Breast cancer: ++ DOCETAXEL TEVA PHARMA 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. + Non-small cell lung cancer: ++ DOCETAXEL TEVA PHARMA is indicated for the
treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. ++
DOCETAXEL TEVA PHARMA 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 TEVA PHARMA in combination with prednisone or prednisolone is indicated for
the treatment of patients with hormone refractory metastatic prostate cancer. - Pharmaceutical form: Concentrate and
solvent for solution for infusion - Route of administration: Intravenous use - Packaging: + Concentrate: vial (glass) +
Solvent: vial (glass) Risk Management Plan: No NB: This exclusive document has been prepared by IDRAC by integrating
the seven or eight files released in English by the EMEA into one comprehensive document. Consequently, the page
numbering is not in sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also
enriched by a detailed Table of Contents provided in the left frame.
Comment: First issue of the EPAR on DOCETAXEL TEVA PHARMA (docetaxel): EMEA/H/C/002032 (119454).
Document date: 03-Feb-2011
Type of text: EPAR
Regulatory version: None
Language: English
European Union - EMA EPAR EMEA/H/C/00699 Revision 11: CHAMPIX
(varenicline)
Name of the medicinal product: CHAMPIX - International Nonproprietary Name: varenicline - Marketing Authorisation
Holder: Pfizer Limited - Pharmaco-therapeutic group - (ATC Code): Active substances used in nicotine dependence -
(N07BA03) - Therapeutic indication: CHAMPIX is indicated for smoking cessation in adults. - Pharmaceutical form: Filmcoated
tablet - Route of administration: Oral use - Packaging: + Bottle + Blister Risk Management Plan: Yes Last changes
since the previous version of this EPAR: Major changes: - Update of Sections 4.2 and 5.1 of the SPC and section 3 of the PL
further to data emerging from clinical study A3051095. C.I.3.b - Implementation of change(s) requested following the
assessment of an USR, class labelling, a PSUR, RMP, FUM/SO, data submitted under A 45/46, or amendments to reflect a
Core SPC - Change(s) with new additional data submitted by the MAH Minor changes: - There have been no minor changes.
NB: This exclusive document has been prepared by IDRAC by integrating the seven or eight files released in English by the
EMEA into one comprehensive document. Consequently, the page numbering is not in sequence, but has been left so that
the user can appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in
the left frame.
Comment: This document replaces the previous version of the EPAR on CHAMPIX (varenicline): EMEA/H/C/699 Revision 10
(115522).
Document date: 28-Jan-2011
Type of text: EPAR
Regulatory version: Revision
Language: English
European Union - EMA EPAR EMEA/H/C/240 Revision 30: REMICADE (infliximab)
Name of the medicinal product: REMICADE - International Nonproprietary Name: infliximab - Marketing Authorisation
Holder: Janssen Biologics B.V. - Pharmaco-therapeutic group - (ATC Code): Tumour necrosis factor alpha (TNFα) inhibitors -
(L04AB02) - Therapeutic indication(s): + Rheumatoid arthritis: ++ Remicade, in combination with methotrexate, is
indicated for the reduction of signs and symptoms as well as the improvement in physical function in: +++ adult patients
with active disease when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has
been inadequate. +++ adult patients with severe, active and progressive disease not previously treated with methotrexate
or other DMARDs. ++ In these patient populations, a reduction in the rate of the progression of joint damage, as measured
by X-ray, has been demonstrated (see section 5.1). + Adult Crohn’s disease: ++ REMICADE is indicated for: +++
treatment of severe, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of
therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for
such therapies. +++ treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full
and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive
therapy). + Paediatric Crohn’s disease: ++ REMICADE is indicated for treatment of severe, active Crohn’s disease, in
paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an
immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. ++
REMICADE has been studied only in combination with conventional immunosuppressive therapy. + Ulcerative colitis: ++
REMICADE is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an
inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA),