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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|Auth. number :||EU/2/11/134|
|ATC:||Anatomical main group: QM - Musculo-skeletal system|
Therapeutic subgroup: QM01 - Antiinflammatory and antirheumatic products
Pharmacological subgroup: QM01A - Antiinflammatory and antirheumatic products, non-steroids
Chemical subgroup: QM01AC - Oxicams
Chemical substance: QM01AC06 - Meloxicam
(See WHO ATCvet Index)
|Indication:||Chronic hepatitis B|
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Chronic hepatitis C
Adult patientsIntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCVRNA) (see section 4.4).The best way to use IntronA in this indication is in combination with ribavirin.
Chidren 3 years of age and older and adolescentsIntronA is indicated, in a combination regimen with ribavirin, for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain The decision to treat should be made on a case by case basis (see section 4.4).
Hairy cell leukaemia
Treatment of patients with hairy cell leukaemia.
Chronic myelogenous leukaemia
MonotherapyTreatment of adult patients with Philadelphia chromosome or bcr/abl translocation positive chronic myelogenous leukaemia.Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ≥ 34 %, but < 90 % Ph+ cells in the marrow.
Combination therapyThe combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.
As maintenance therapy in patients who have achieved objective remission (more than 50 % reduction in myeloma protein) following initial induction chemotherapy.Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.Follicular lymphomaTreatment of high tumour burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
|Marketing Authorisation Holder:||Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|13/12/2011||Centralised - Authorisation||EMEA/V/C/2497||(2011)9445 of 09/12/2011|
|20/08/2012||Centralised - Variation||EMEA/V/C/2497/X/2||(2012)5891 of 16/08/2012|
|12/11/2012||Centralised - Variation||EMEA/V/C/2497/X/1||(2012)8179 of 08/11/2012|
|14/02/2013||Centralised - Variation||EMEA/V/C/2497/WS/344||(2013)913 of 12/02/2013|
|27/09/2013||Centralised - Variation||EMEA/V/C/2497/IB/5|