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M-M-R II powder for injection vial with pre-filled diluent syringe, single dose, Merck Sharp and Dohme (Australia) Pty Limited, CON-264
Product name
M-M-R II powder for injection vial with pre-filled diluent syringe, single dose
Sponsor name
Merck Sharp and Dohme (Australia) Pty Limited
Batches
R011834
Consent start
Consent no.
CON-264
Standard
Section 7(2)(a) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The newly implemented double detachable labels for the vaccine vial are
obscuring some of the information on the vial label as follows#58; the name of
the medicine the name of the active ingredients in the medicine the name of the
dosage form the quantity of the medicine the approved route of administration
Conditions imposed
1.This consent applies only to M-M-R II powder for injection vial with
pre-filled diluent syringe, single dose (201877), batch R011834 (expiry
23 February 2020, quantity#58; 50,400).
2. Non-compliance with the TGO 91 is limited to the information detailed in
the submission.
3. A 'Dear Healthcare Professional' letter identical to that provided to the
TGA on 18 May 2018 will be supplied with each affected batch warning that some
of the text including the trade name on the main label is obscured and upon
removal of the detachable labels, the text on the main label is fully visible.
4. The distributor for the labels to which this consent applies is Seqirus
and arrangements are in place with the distributor Seqirus' Medical Information
Department on 1800 642 865 for the prompt referral of any queries or complaints
concerning the product.
Therapeutic product type
Prescription medicines