Opko Health Inc (OPK)

[WiseFool]

Opko EirGen Product Approvals

EIRGEN PHARMA ONCOLOGY PRODUCT EIR-080
EirGen Pharma oncology molecule ‘Eir-080' product was developed for treatment of adults with newly-diagnosed glioblastoma multiforme, and also for the treatment of children 3 years and older and adult patients with malignant glioma.

RECEIVES APPROVAL IN:
UKRAINE
UK
HUNGARY
SWITZERLAND
SERBIA

EIRGEN PHARMA ONCOLOGY PRODUCT EIR-050
EirGen Pharma molecule ‘Eir-050' product was developed for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer.

RECEIVES APPROVAL IN:
U.S.
BOSNIA HERZEGOVINA
UKRAINE
SINGAPORE
TAIWAN
HONG KONG
KOSOVO

EIRGEN PHARMA ONCOLOGY PRODUCT EIR-012
EirGen Pharma oncology molecule ‘Eir-012' product was developed for first line treatment in postmenopausal women with hormone-dependent breast cancer.

RECEIVES APPROVAL IN:
SWITZERLAND
HONG KONG
CROATIA

EIRGEN PHARMA BREAST CANCER PRODUCT EIR-070 PASSES CLINICAL TRIAL
EirGen Pharma oncology molecule ‘Eir-070' has successfully passed clinical trial studies in Japan in November 2013 . This product was developed as an treatment for postmenopausal women with estrogen-receptor postive early breast cancer and represents the fifth successful clinical trial for EirGen Pharma in Japan.

EIRGEN PHARMA REGISTERS ONCOLOGY PRODUCT EIR-050 WITH SFDA
EirGen Pharma oncology molecule Eir-050 was submitted to the Saudi Food and Drug Authority (SFDA) in July 2013. This product was developed as an adjuvant treatment of postmenopausal women with estrogen-receptor postive early breast cancer and represents the first of several planned marketing authorisation applications in the Gulf Region. Company Co-Founder and Chief Technical Officer Tom Brennan commented “This marks another key milestone for our organisation as we continue to grow and expand into new territories and is another significant achievement for our company”.

EIRGEN PHARMA PRODUCT EIR-115 APPROVED BY PMDA
EirGen Pharma ‘Letrozole’ Japan application has been approved by the PMDA (the Japanese Health Authority) after the application being filed in February 2014. Letrozole was developed for first line treatment in postmenopausal women with hormone-dependent breast cancer.

EIRGEN PHARMA PRODUCT EIR-111 SUBMITTED FOR LICENSE APPROVAL
EirGen Pharma product Eir-111 submitted for license approval in the European Union. This product is a corticosteroid which successfully passed its Bioequivalence Study in Q4 2014.

Reference OpkoDD Post