Irlanda - anglès - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - amitriptyline hydrochloride - oral solution - 50 mg/5ml - non-selective monoamine reuptake inhibitors; amitriptyline

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - pralsetinib, quantity: 100 mg - capsule, hard - excipient ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue fcf; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - non-small cell lung cancer (nsclc),gavreto has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc). the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor) in single-arm trials. continued approval of this indication depends on verification and description of benefit in confirmatory trials. ret-fusion positive thyroid cancer,gavreto has provisional approval in australia for the treatment of adult patients with advanced or metastatic ret-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

australian naturalcare products pty ltd - capsicum annuum,magnesium citrate,viburnum opulus,zingiber officinale -

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - amitriptyline hydrochloride - oral tablet - 50mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - amitriptyline hydrochloride - oral tablet - 25mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

almus pharmaceuticals ltd - amitriptyline hydrochloride - oral tablet - 25mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - amitriptyline hydrochloride - oral tablet - 25mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - nortriptyline hydrochloride - oral tablet - 50mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - nortriptyline hydrochloride - oral tablet - 50mg

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - nortriptyline hydrochloride - oral tablet - 50mg