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Merck Sharp and Dohme (Australia) Pty Limited, from CON-264, M-M-R II powder for injection vial with pre-filled diluent syringe, single dose

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
ARTG
Decision date
Year
2018
Consent no.
CON-264
Duration
The consent is effective from 25 May 2018 until 23 February
2020.
Standard
Section 7(2)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91).
Supply/Import or Export
Import and supply
Therapeutic good type
Prescription medicines
Batches
R011834
Conditions

1.This consent applies only to M-M-R II powder for injection vial with pre-filled diluent syringe, single dose (AUST R 201877), batch R011834 (expiry 23 February 2020, quantity: 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.

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:
  • 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

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