TGA publishes another 6 AusPARs

TGA

25 September 2015 - The TGA has published another six AusPARs. 

Medicine (brand name) EllaOne OptaFlu Decapeptyl Xeomin MabThera Hemangiol
Medicine (generic name) Ulipristal acetate Influenza vaccine (trivalent)  Triptotelin acetate Botulinum toxin type A Rituximab Propranolol hydrochloride
Sponsor/Applicant ERA Consulting Novartis Vaccines & Diagnostics Ferring Pharmaceuticals Merz Pharmaceuticals Roche Pierre Fabre
Disease/condition Contraception Influenza Female infertility Muscle spasticity, blepharospasm, glabellar lines Rheumatoid arthritis Haemangioma
Purpose New medicine New formulation New indication New formulation New dosage and administration New indication
Date of decision 25 February 2015 3 March 2015 26 February 2015 17 March 2014 5 March 2015 18 June 2015
Date of AusPAR 4 September 2015 24 August 2015 24 August 2015 10 September 2015 27 August 2015 19 August 2015

 

MAESTrO Insight: The submission for Hemangiol was rejected by the TGA Delegate on 19 June 2014.

Michael Wonder

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Michael Wonder