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.