European Union - English - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparaginase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years and adults.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 1500 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreaticcancer.gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage.breast cancer:gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locallyrecurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated.ovarian cancer:gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

medac gmbh - hydroxycarbamide - capsules - 500mg

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 60512 - shoulder humeral body prosthesis - an eccentric tapered connector that is connected to the anatomic metaphysis by means of a press-fit cylinder. the humeral head is then coupled to the double eccenter by means of an eccentric morse taper connection. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 60512 - shoulder humeral body prosthesis - the anatomic metaphysis is a wedged component that has to be mounted on the humeral diaphysis in order to obtain an anatomic stem. the possibility to adjust the inclination of the proximal plane of the anatomic stem is important to correctly reconstruct the inclination of the humeral head of the patient. the device is available in 3 inclination options, providing 128?, 135? and 142? ccd angles the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 48088 - humeral head prosthesis - the humeral head is coupled to the double eccenter by means of an eccentric morse taper connection. the double eccenter provides a 2.5mm offset with respect to the stem, while the humeral head provides a 2.5mm offset with respect to the double eccenter. by adjusting the angular positions of the double eccenter and the humeral head, it is possible to obtain infinite offset values ranging from 0mm to 5mm in infinite possible directions. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Australia - English - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the anatomic glenoid implant is a polyethylene (pe) component characterized by a spherical surface articulating on the humeral head, and a pattern of fixation pegs to be press-fit and cemented into the bone. the pegs have barbed structures that deform while the pegs are inserted into the bone, providing an immediate fixation even when the cement is still hardening. the anatomic medacta shoulder system is intended for use as a hemi or total shoulder replacement. it is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. the humeral components are for cemented and cementless use.

Malta - English - Medicines Authority

medac gesellschaft fur klinische spezialpräparate mbh theaterstr. 6 22880 wedel, germany - powder for solution for injection - bleomycin sulfate 15,000 iu - antineoplastic agents

Israel - English - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 200 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - gemcitabine as hydrochloride - powder for solution for infusion - gemcitabine as hydrochloride 1000 mg - gemcitabine - gemcitabine - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer.gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.