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PRODUCTS

Oncology and Onco-Hematology

Celnova Pharma aims to preserve and improve the lives of people facing serious medical conditions. Our development and commercial efforts are completely focused in specialty drugs, providing patients a wide range of therapies for treatment.

WARNING!
In Argentina, all communication related to medicinal products sold under prescription is regulated by the ANMAT. The product information included in this website is the one contained in the last approved prospectus by the regulatory authority, and it is offered only for informative or educational purposes, without commercial purposes. It does not intend to replace the opinions and recommendations of health professionals, who are the ones who must make the decisions regarding the prescribing information, taking into account the unique characteristics of each patient.

PRODUCTS

Abiranova ®

Drug:  Abiraterone Acetate 250 mg.

Pharmaceutical form: Tablets.

Presentation: Container with 120 tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: ABIRANOVA in combination with Prednisone or prednisolone is indicated for:

  • Treatment of patients with castration-resistant metastatic prostate cancer (RTPCS) who have previously received chemotherapy with docetaxel.
  • Treatment of castration-resistant metastatic prostate cancer in adult men who are asymptomatic or slightly symptomatic following the failure of androgen deprivation treatment in which chemotherapy is not yet clinically Indicated.
Arimidex ®

Drug:  anastrozole 1 mg.

Pharmaceutical form: Tablets.

Presentation: Container with 28 tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: ARIMIDEX is an aromatase inhibitor indicated for:

  1. Adjuvant treatment of postmenopausal women with
    hormone receptor-positive early breast cancer
  2. First-line treatment of postmenopausal women with
    hormone receptor-positive or hormone receptor unknown
    locally advanced or metastatic breast cancer
  3. Treatment of advanced breast cancer in postmenopausal
    women with disease progression following tamoxifen
    therapy. Patients with ER-negative disease and patients
    who did not respond to previous tamoxifen therapy rarely
    responded to ARIMIDEX

ARIMIDEX is a registered trademark of the AstraZeneca group of companies.

Azanova ®

Drug:  Azacitidine 100mg

Pharmaceutical form: Lyophilized powder for injection

Presentation: Lyophilized powder in 100 mg single-dose vials

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications:  AZANOVA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with
ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), chronic myelomonocytic leukemia (CMMoL), and acute myeloid leukemia with 20-30% blasts and multilineage dysplasia.

Capecinova ®

Drug:  Capecitabine 500 mg.

Pharmaceutical form: coated tablers.

Presentation: case contaning 120 tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: CAPECINOVA is indicated for adjuvant treatment after surgery in patients with stage III colon cancer (Dukes stage C) and as monotherapy in the first line of metastatic colorectal cancer. It is also indicated for the first line treatment of advanced gastric cancer with a platinum-containing regimen.

CAPECINOVA in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. The previous therapy must have included an anthracycline. It is also indicated in monotherapy for patients with locally advanced or metastatic breast cancer after failure with taxanes and a chemotherapeutic regimen that includes an anthracycline or for those patients for whom no further therapy with anthracyclines is indicated.

Cipronova ®

Drug: Cyproterone acetate 50mg

Pharmaceutical form: tablets.

Presentation: container with 50 tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: CIPRONOVA ® is indicated for:

  • Non-tumoral female hirsutism
  • Palliative prostate Cancer
Dasanova ®

Drug: Dasatinib 100 mg

Pharmaceutical form: Coated tablets.

Presentation: Case containing 3 blisters of 10 coated tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications:

  • Chronic myeloid leukemia (CML) with Philadelphia chromosomes positive (Ph +) in a newly diagnosed chronic phase.
  • LCM Ph + in chronic phase, accelerated or myeloblastic, with resistance or intolerance to previous treatment, including imatinib.
  • Acute lymphoblastic leukemia with Philadelphia chromosomes positive (LLA Ph +), with resistance or intolerance to previous treatment.
Ekel ®

Drug: Pemetrexed (disodium hemipentahidrato) 500 mg.

Pharmaceutical form: Lyophilized powder injectable.

Presentation:  lyophilized powder in single-dose vial.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Treatment of non-squamous cell lung cancer at locally advanced or metastatic non-small cells in combination with cisplatin. Maintenance treatment of locally advanced or metastatic non-scaly non-small cell lung cancer, whose disease has not progressed after four cycles of cisplatin regimen as first-line chemotherapy. Non-squamous nonsmall cell lung cancer treatment after pre-chemotherapy as a single agent. In combination with cisplatin for the treatment of pleural mesothelioma whose disease is unresectable or non-candidate patients for curative surgery. It is not indicated for the treatment of patients with squamous cell lung cancer in non-small cells.

Faslodex ®

Drug: fulvestrant 250 mg.

Pharmaceutical form: injectable.

Presentation:  2 prefilled syringe 5ml

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Faslodex is an estrogen receptor antagonist indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

FASLODEX is a trademark of the AstraZeneca group of companies.

Gefinova ®

Drug: gefitinib 250 mg.

Pharmaceutical form: Coated tablets

Presentation:  case containing 30 coated tablets

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: GEFINOVA® is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) deletions or substitution mutations.

Gefitinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients that have previously received chemotherapy treatment.

Gemcinova ®

Drug: Gemcitabine 200mg and 1000 mg.

Pharmaceutical form: Lyophilized powder for injection.

Presentation: Case containing 1 vial.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Ovarian cancer: gemcitabine in combination with carboplatin is indicated in the treatment of patients with locally advanced or metastatic epithelial carcinoma of the ovary with recurrent disease, after a relapse-free interval of at least 6 months After a platinum-based first-line treatment.

Breast cancer: Gemcitabine is a combination of Paclitaxel is indicated in the treatment of metastatic or locally advanced non-resectable breast cancer, provided that these patients have resorted to prior adjuvant or neoadjuvant chemotherapy treatment. Prior chemotherapeutic treatment should have contained an anthracycline unless it was clinically contraindicated.

Non-small cell lung cancer: Gemcitabine is indicated in combination with Cisplatin for the first line treatment of patients with inoperable lung cancer, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) of non-small cells.

Pancreatic cancer:  Gemcitabine is indicated as first line treatment of patients with locally advanced pancreatic adenocarcinoma (stage II not extirpated or stage III) or metastatic (stage IV) gemcitabine is indicated for patients previously treated with 5-FU.

Bladder cancer: Gemcitabine is indicated in the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.

DISEASE AREAS

  • Epithelial ovarian Carcinoma
  • Metastatic or locally advanced breast cancer non resectable
  • Non-small cell lung cancer
  • Pancreatic Adenocarcinoma
  • Bladder cancer
Imatinova

Drug: Imatinib (as Mesylate) 400 mg.

Pharmaceutical form: Coated tablets.

Presentation: Container with 30 coated tablets.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: It is indicated for the treatment of patients with: recent diagnosis of chronic myeloid leukemia. Chronic myeloid leukemia when treatment with interferon-Alfa fails. Chronic myeloid leukemia in blastic crisis and chronic myeloid leukemia in accelerated phase. Gastrointestinal stromal neoplasm Kit (CD 117) non-resectable and/or metastatic positive in adult patients.

Treatment of patients with: recent diagnosis of chronic myeloid leukemia, Philadelphia chromosome positive (Ph +) (BC-ABL) of recent diagnosis for which bone marrow transplantation is not considered first-line treatment; In the treatment of patients with chronic myeloid leukemia Ph +, in chronic phase after the failure of treatment with interferon-alfa, or in accelerated phase or blastic crises. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib is also indicated in the treatment of adult patients with non-resectable malignant gastrointestinal stromal tumours and or metastatic Kit (CD 117) positive. In adult patients the effectiveness of imatinib is based on global hematological and cytogenetic response rates and on progression-free survival in chronic myeloid leukemia and in the objective response rate in tumors of the gastrointestinal stroma. The experience with imatinib in children with chronic myeloid leukemia is very limited. There are no controlled trials that demonstrate the clinical benefit or increased survival for either of the two diseases.

Lenalinova ®

Drug: Lenalidomide 10 and 25 mg.

Pharmaceutical form: hard capsules

Presentation: Container with 21 hard capsules.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications:

Myelodysplastic syndrome (SMD): LENALINOVA is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1 myelodysplastic syndromes linked to a cytogenetic abnormality of 5q deletion with or without cytogenetic abnormalities. Additional.

Multiple Myeloma (MM): LENALINOVA in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma.

Mantle cell lymphoma (LCM): LENALINOVA is indicated for the treatment of patients with mantle cell lymphoma (LCM), who have suffered relapse or progression of the disease after receiving two previous therapies, in one of which has used Bortezomib.

DISEASE AREAS

  • Myelodysplastic syndrome
  • Multiple myeloma
  • Mantle cell lymphoma
INFORMED CONSENT FORM
Oxalinova ®

Drug: Oxaliplatin 50 and 100 mg.

Pharmaceutical form: Lyophilized powder for injection.

Presentation: Case containing 1 vial.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Oxaliplatin in combination with 5-fluorouracil (5-FU) and leucovorin (LV) is indicated for the adjuvant treatment of colon cancer III (Duke’s C) after complete resection of the primary tumor. Treatment of metastatic colorectal cancer.

Paclinova ®

Drug:  Paclitaxel 30, 100, 150, 300 mg.

Pharmaceutical form:  Injectable solution

Presentation:  Case containing 1 vial.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications:

  • First-line and subsequent therapy for the treatment of advanced ovarian carcinoma. As first-line therapy, Paclitaxel treatment is indicated in combination with cisplatin.
  • Adjuvant treatment of breast cancer positive nodule, administered sequentially, with standard chemotherapy with combined doxorubicin.
  • Treatment of breast cancer in cases where combined chemotherapy for metastasica disease or recurrence had failed within 6 months of adjuvant therapy. Pre-treatment should have included an anthracycline, unless it is clinically contraindicated.
  • Paclitaxel, combined with cisplatin, is indicated as the first line of treatment for non-small cell lung cancer in patients unfit for potentially curative surgery and/or radiotherapy.
  • Second line of treatment for AIDS-related Kaposi’s Sarcoma.
Temonova ®

Drug: Temozolomide 20 mg, 100 mg and 250 mg.

Pharmaceutical form: Hard capsule.

Presentation: Container with 5 hard capsules.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Treatment of patients with recent diagnosis of glioblastoma multiforme concomitantly with radiotherapy and later as adjuvant therapy, treatment of patients with malignant glioblastoma, such as glioblastoma multiforme or astrocytoma Anaplastic that present recurrence or progression after conventional therapy.

Zoladex ®

Drug: goserelin 3,6 mg and 10,8 mg.

Pharmaceutical form: implant.

Presentation: Container with 1 implant.

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for:

  1. Use in combination with flutamide for the management of locally confined carcinoma of the prostate
  2. Palliative treatment of advanced carcinoma of the prostate
  3. The management of endometriosis
  4. Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding
  5. Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women

ZOLADEX is a trademark of the AstraZeneca group of companies.

Zolenova ®

Drug: zoledronic acid 4mg

Pharmaceutical form: lyophilized powder for injection

Presentation: 4 mg per 5 mL single-use vial of concentrate

Product Availability:  Argentina (if you are interested in purchasing this product for other markets, please contact us).

Authorized indications: Zolenova is a bisphosphonate indicated for the treatment of:
• Hypercalcemia of malignancy
• Patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with standard antineoplastic
therapy. Prostate cancer should have progressed after treatment with at
least one hormonal therapy