28 July 2017 EMA/477555/2017 Human Medicines Evaluation Division
COOK IVF cell media Procedural steps and scientific information after initial consultation
Application
Scope
Opinion/ Notification
number
Summary 1
issued on IA/0003
Minor changes to an ancillary medicinal substance
11/11/2016
- Post consultation procedure equivalent to IA IB/0002
Minor changes to an ancillary medicinal substance
Mile Plains, Queensland 4113, Australia, as a manufacturer of the medical device(s). 24/06/2015
- Post consultation procedure equivalent to IB IB/0001
B.II.d.2.d - Change in test procedure for the finished product - Other changes to a test
To delete William A. Cook Australia Pty. Ltd. 95 Brandl St, Brisbane Technology Park, Eight
To add Cook Pharmica LLC, 1300 S. Patterson Drive, Bloomington, Indiana 47403, USA as a new manufacturer of the medical device(s).
05/10/2012
Changes to a test procedure (including replacement or addition) for the ancillary substance in the medical device.
procedure (including replacement or addition)
1
Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II variation or extension application or a worksharing application). Opinions are issued for all other procedures. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact
COOK IVF cell media - procedural steps and scientific information after ...
Jul 28, 2017 - COOK IVF cell media. Procedural steps ... Ltd. 95 Brandl St, Brisbane Technology Park, Eight ... a new manufacturer of the medical device(s).
Jul 28, 2017 - Application number. Scope. Opinion/ ... Inc. company) 1979 E. Locust Street, Pasadena CA, 91107 USA with Origio a/s (a. CooperSurgical, Inc.
Send a question via our website www.ema.europa.eu/contact. 28 July 2017 ... the AS, starting material, reagent or intermediate used in the manufacture of the ...
Jul 28, 2017 - 15/06/2015. To replace the manufacturer of the medical device Sage IVF, Inc. (a CooperSurgical,. Inc. company) 1979 E. Locust Street, ...
E-mail [email protected] Website www.ema.europa.eu .... Can an applicant apply for small and medium-sized enterprise (SME) status? ..... recommended to ensure the adequacy and the readability of the design and content of the package.
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