Ireland - English - HPRA (Health Products Regulatory Authority)

profile pharma limited - colistin mesilate sodium - powder for nebuliser solution - 1 million international unit - polymixins

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

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

profile pharma ltd - safinamide methansulfonate - tablet - 100mg

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - docetaxel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastic agents - breast cancerdocetaxel teva pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.non-small-cell lung cancerdocetaxel teva pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.docetaxel teva pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancerdocetaxel teva pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 100mg - chewable/dispersible tablet - 100 mg - active: lamotrigine 100mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 200mg - chewable/dispersible tablet - 200 mg - active: lamotrigine 200mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 25mg - chewable/dispersible tablet - 25 mg - active: lamotrigine 25mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 50mg - chewable/dispersible tablet - 50 mg - active: lamotrigine 50mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol