European Union - English - EMA (European Medicines Agency)

holostem s.r.l - ex vivo expanded autologous human corneal epithelial cells containing stem cells - stem cell transplantation; corneal diseases - ophthalmologicals - treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. a minimum of 1-2 mm2 of undamaged limbus is required for biopsy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

chiesi ltd - autologous human corneal epithelial cells - living tissue equivalent - 197500cell/1square cm

European Union - English - EMA (European Medicines Agency)

fondazione telethon ets - autologous cd34+ enriched cell fraction that contains cd34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ada) cdna sequence from human haematopoietic stem/progenitor (cd34+) cells - severe combined immunodeficiency - immunostimulants, - strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ada-scid), for whom no suitable human leukocyte antigen (hla)-matched related stem cell donor is available (see section 4.2 and section 4.4).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

grifols malaysia sdn. bhd. - human immunoglobulin proteins -

European Union - English - EMA (European Medicines Agency)

vericel denmark aps - autologous cultured chondrocytes - fractures, cartilage - other drugs for disorders of the musculo-skeletal system - repair of symptomatic cartilage defects of the knee.

Ireland - English - HPRA (Health Products Regulatory Authority)

ex-lax limited - phenolphthalein -

Ireland - English - HPRA (Health Products Regulatory Authority)

ex-lax limited - phenolphthalein -

Ireland - English - HPRA (Health Products Regulatory Authority)

ex-lax limited - phenolphthalein -

European Union - English - EMA (European Medicines Agency)

dendreon uk ltd - autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous cd54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor - prostatic neoplasms - other immunostimulants - provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.

New Zealand - English - Medsafe (Medicines Safety Authority)

carsl consulting - remestemcel-l (100 million human mesenchymal stem cells in 15ml) - solution for infusion - 100 million cells in 15ml - active: remestemcel-l (100 million human mesenchymal stem cells in 15ml) excipient: albumin dimethyl sulfoxide plasma-lyte a - prochymal is indicated for the rescue of patients nlt 6 months to 17 years of age with acute graft versus host disease (agvhd), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents. prochymal use under these conditions is limited to grades b to d of the disease.