Betahistine dihydrochloride (SERC) 16 mg tablet blister pack, Mylan EPD, CON-152
Product name
Betahistine dihydrochloride (SERC) 16 mg tablet blister pack
Sponsor name
Mylan EPD
Consent start
Consent no.
CON-152
Standard
Paragraph 3(2)(l) of the Therapeutic Goods Order No.69 General requirements for the labels for medicines.
Non-compliance with standard
The product labels do not include the current address of the sponsor.
Conditions imposed
The labels to which this consent applies are those previously approved for
the former address 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