Ireland - English - HPRA (Health Products Regulatory Authority)

vet-agro multi-trade company sp z o.o. - cabergoline - oral solution - 50 microgram(s)/millilitre - cabergoline

European Union - English - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberculosis, multidrug-resistant - antimycobacterials - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - tuberculin purified protein derivative 27mg (freeze dried attentuated strain-mycobacterium bovis) - powder for injection - 27 mg - active: tuberculin purified protein derivative 27mg (freeze dried attentuated strain-mycobacterium bovis) excipient: monosodium glutamate dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - tuberculin purified protein derivative 81mg - powder for injection - 81 mg - active: tuberculin purified protein derivative 81mg excipient: monosodium glutamate

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - bedaquiline fumarate - tuberculosis, multidrug-resistant - antimycobacterials - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (mdr tb) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

sol-millennium medical pty ltd - 63096 - tuberculin/allergy syringe/needle, basic - the syringe is a sterile, single-use device used to inject vaccine into the patient.

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

sol-millennium medical pty ltd - 32592 - tuberculin-allergy syringe/retractable-needle - the retractable syringe is a sterile, single-use device used to inject vaccine into the patient.the syringe is designed with a needle retraction mechanism allowing the needle to be shielded to aid in the prevention of needle stick injures.

Namibia - English - Namibia Medicines Regulatory Council

litha vaccines (pty) ltd - tubeculin - injection - each 1ml liquid contains 0.4?g tuberculin purified protein derivative batch rt 23

Israel - English - Ministry of Health

j-c health care ltd - bedaquiline as fumarate - tablets - bedaquiline as fumarate 100 mg - bedaquiline - sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (mdr-tb) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.