28 July 2017 EMA/478452/2017 Human Medicines Evaluation Division
Gems Medium Suite Procedural steps and scientific information after initial consultation
Application
Scope
Opinion/
Summary
Notification 1
number
issued on IB/0003
Minor changes to an ancillary medicinal substance
19/08/2016
To introduce an additional medium, Geri Medium.
02/02/2016
To introduce an additional medium, Gavi Medium Cartridge (GAVI-MED-20), and to
- Post consultation procedure equivalent to IB IB/0002
Minor changes to an ancillary medicinal substance - Post consultation procedure equivalent to IB
remove the following media: Sperm Medium with pentoxifylline, Sperm Buffer with pentoxifylline, Cleavage Stage Freezing Set, Cleavage Stage Thawing Set, Blastocyst Stage Freezing Set and Blastocyst Stage Thawing Set.
IA/0001
Minor changes to an ancillary medicinal substance - Post consultation procedure equivalent to IA
02/07/2015
To change the name and address of the medical device manufacturer from Genea Biomedx UK LTD, 10-18 Union Street, London SE1 1SZ, United Kingdom, to Genea Biomedx PTY LTD, Level 2, 321 Kent Street, Sydney NSW 2000, Australia.
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
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, ...
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 - COOK IVF cell media. Procedural steps ... Ltd. 95 Brandl St, Brisbane Technology Park, Eight ... a new manufacturer of the medical device(s).
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