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SERC Betahistine dihydrochloride 16 mg tablet blister pack, Mylan Health Pty Ltd, CON-227
Product name
SERC Betahistine dihydrochloride 16 mg tablet blister pack
Sponsor name
Mylan Health Pty Ltd
Consent start
Consent no.
CON-227
Standard
Subclause 3(2)(l) of the Therapeutic Goods Order No.69 '“ General requirements for the labels for medicines
Non-compliance with standard
The labels do not bear the current sponsor's name and address.
Conditions imposed
The labels to which this consent applies are those previously approved for
the former name and address BGP products Pty Ltd, 299 Lane Cove Road, Macquarie
Park NSW 2113. Arrangements are in place with divisions that operate at this
address for the prompt referral of any queries or complaints concerning the
products to the current address (Level 1, 30-34 Hickson Road, Millers Point NSW
2000).
Therapeutic product type
Prescription medicines