GB Pharma
as Marketing Authorization Holder

GB PHARMA AS MAH

GB Pharma S.r.l. was founded in 2006 as part of the GB Pharma Group, as a consulting company focused on Regulatory Affairs, Quality Assurance and Post-Marketing Pharmacovigilance services.

Thanks to the integrated skills, acquired within the GB Pharma Group, which is able to provide high level consulting even in Clinical Research, BioEquivalence studies, Non-Interventional Studies, Epidemiology and “Outcome Research” studies,  GB Pharma Group goes from being a CRO to become a CLINICAL DEVELOPMENT COMPANY.

In 2010 GB Pharma S.r.l. acquired the Italian MA of a tamoxifen citrate containing product to be used in the treatment of breast cancer. GB Pharma S.r.l. still is the MARKETING AUTHORIZATION HOLDER (MAH) of this product in Italy.

Being a MAH itself, GB Pharma S.r.l. is able to understand the specific needs, the concerns, the doubts and the requirements of its clients which are MAHs themselves. This is part of the ADDED VALUE SERVICE that GB Pharma S.r.l. is able to grant to each one of its Client.

BREAST CANCER

It has been estimated that in 2018 about 52,800 new cases of breast cancer were diagnosed in Italy. Of these, 99% (52,300 cases) are related to women while 1% to men (500 cases). Not considering skin cancers, breast cancer is the most diagnosed cancer in women, in which about one in every three malignancies (29%) is a breast cancer. In the whole population, the percentage is 14% and breast cancer remains the most diagnosed cancer.

The risk of breast cancer increases with increasing age, as the incidence curve grows exponentially up to the menopause years (around 50-55 years) and then slows down with a plateau after the menopause, and then starts to rise again after the age of 60.

Risk factors:

  • Reproductive factors: a long duration of the fertile period, nulliparity, a first term pregnancy after 30 years, failure to breastfeed.
  • Hormonal factors: increased risk in women taking hormone replacement therapy during menopause or taking oral contraceptives.
  • Dietary and metabolic factors.
  • Previous radiotherapy.
  • Previous breast dysplasia or malignancies.
  • Familiarity and heredity.

The incidence trend of breast cancer in Italy appears to be slightly increasing (+ 0.3% per year) while mortality continues to drop significantly (-0.8% per year).

The reduction in mortality can be obtained through an early diagnosis or a reduction in the incidence. The first takes place through the use of a mammography screening program, while the second through the implementation of primary prevention, aimed at limiting the effect of risk factors for this cancer, which is currently applied only through the adoption of appropriate lifestyles.

Bilateral mammography is currently considered the most effective screening test for the early diagnosis of breast cancer.

Contacts

For any information regarding the product of GB Pharma S.r.l. please contact: info@gbpharma.it

For medical enquiries or pharmacovigilance requests, please contact: safetydept@gbpharmaservices.it

GB Pharma Services & Consulting Srl Codice fiscale/P.IVA 01900980184
GB Pharma Srl Codice fiscale/P.IVA 02183430186