Full and unabridged extracts from
Page 6: Oral Explanation
Page 17: Withdrawal of initial application
referring to the Tissue Therapies application.
1. Oral Explanations
1.1 Pre-authorisation procedure oral explanations
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(EMEA/H/D/002831), (insulin-like growth factor 1 segment), (hard-to-heal wounds, primarily venous leg ulcers) List of Outstanding Issues adopted on 25.09.2014. List of Questions adopted on 23.01.2014.
An Oral explanation was held on Wednesday 25 March 2015 at 11.00.
The Committee adopted the BWP Report. The Committee noted that the applicant has withdrawn the request.
See section 8 Withdrawal of initial application
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8. Withdrawal of initial application
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(EMEA/H/D/002831), (insulin-like growth factor 1 segment), , (hard-to-heal wounds, primarily venous leg ulcers) List of Outstanding Issues adopted on 25.09.2014. List of Questions adopted on 23.01.2014.
See also section 1.1. Pre-authorisation procedure oral explanations
An Oral explanation was held on Wednesday 25 March 2015 at 11.00.
It was agreed that the company will be provided scientific advice.
The Committee adopted the BWP Report.
The Committee noted that the applicant has withdrawn the application.
Please note that BWP stands for 'Biological Working Party'. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000103.jsp
The Biologics Working Party (BWP) was established to provide recommendations to the EMEA scientific committees on all matters relating directly or indirectly to quality and safety aspects relating to biological and biotechnological medicinal products, including, but not limited to, the tasks defined below .....
TIS Price at posting:
10.0¢ Sentiment: Hold Disclosure: Held
