Austrália - inglês - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - pancreatic extract, quantity: 601.2 mg/g (equivalent: protease, qty 2000 ph eur unit; equivalent: amylase, qty 36000 ph eur unit; equivalent: lipase, qty 50000 ph eur unit) - granules, enteric-coated - excipient ingredients: hypromellose phthalate; cetyl alcohol; dimeticone 1000; macrogol 4000; triethyl citrate - creon micro is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (pei). pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. bilroth ii gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).

União Europeia - inglês - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - glucose monohydrate ; calcium chloride dihydrate ; magnesium chloride anhydrous ; sodium chloride ph.eur.; sodium bicarbonate ; sodium lactate - solution for dialysis - 13.6 micromol - hypertonic solutions

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

cellmed pty ltd - 62246 - gastro-oesophageal ph/impedance catheter, non-sterile - intended to monitor the ph in the patient's stomach and oesophagus using ph and/or impedance sensors

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

xcore services sdn bhd - sodium chloride ph eur; calcium chloride dihydrate ph. eur.; magnesium chloride hexahydrate pheur; sodium bicarbonate ph. eur.; potassium chloride ph eur; glucose monohydrate, ph eur -

Cingapura - inglês - HSA (Health Sciences Authority)

easmed asia pte. ltd. - gastroenterology & urology - the restech dx–ph measurement system is intended for gastroesophageal ph measurement and monitoring of gastric reflux. the ph data recorder and data viewing program are intended for gastroesophageal ph data acquisition and analysis to diagnose reflux disorders.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

innologic pty ltd - 15137 - electrode, ph - gastrointestinal probes used with a gastrointestinal monitor for monitoring of bolus in the gastrointestinal tract using ph and/or impedance.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 36965 - patient data recorder, long-term, gastric ph - the accutrac and digitrapper are ambulatory monitoring systems that allow for accurate acquisition and analysis of ph (and optionally, impedance) within the gastrointestinal tract.

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 47602 - vaginal ph suppository - lactic acid is used to maintain and restore natural ph levels in the vagina. using lactic acid to acidify the vaginal environment supports the growth of bacteria typically found in the vagina (lactic acid-producing lactobacilli = lactic acid bacteria), whilst having a negative effect on the growth of disease-causing germs. the device can therefore be used to prevent vaginal infections in women prone to such conditions and as a supplement to drug therapy in vaginal infections.