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BRIEF-Oxford Pharmascience ‍receives advice from MHRA on marketing authorisation for product containing oxpzero ibuprofen​
October 2, 2017 / 10:01 AM / 2 months ago

BRIEF-Oxford Pharmascience ‍receives advice from MHRA on marketing authorisation for product containing oxpzero ibuprofen​

Oct 2 (Reuters) - Oxford Pharmascience Group Plc

* ‍RECEIVED WRITTEN ADVICE FROM MHRA REGARDING APPLICATION FOR MARKETING AUTHORISATION FOR PRODUCT CONTAINING OXPZERO IBUPROFEN​

* ‍MHRA SAYS APPLICATION CAN BE SUBMITTED AS A HYBRID APPLICATION ​

* ‍MHRA DID NOT CONSIDER OXPZERO IBUPROFEN PRODUCT TO BE BIOEQUIVALENT TO REFERENCE DUE TO FASTER TMAX COMPARED TO REFERENCE PRODUCT

* ‍MHRA REQUIRES ADDITIONAL CLINICAL DATA ON SAFETY AND EFFICACY TO SUPPORT MARKETING AUTHORISATION APPLICATION​ Source text for Eikon: Further company coverage:

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