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RANI 2 ranitidine 300mg (as hydrochloride) tablet blister pack (Suspension effective for 6 months.
A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act. )
Product name
RANI 2 ranitidine 300mg (as hydrochloride) tablet blister pack
Sponsor
ARTG
Suspension from the ARTG under s.29D(1)(b)
Date action takes effect
Lapse date
Compliance action
Alphapharm Pty Ltd
Type of action
Suspension effective for 6 months.
A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.
A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.
Device names
Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.