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AZN Astrazeneca Plc

12,106.00
-20.00 (-0.16%)
19 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Astrazeneca Plc LSE:AZN London Ordinary Share GB0009895292 ORD SHS $0.25
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -20.00 -0.16% 12,106.00 12,120.00 12,122.00 12,190.00 12,024.00 12,080.00 999,558 16:35:02
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 45.81B 5.96B 3.8415 31.55 187.98B

Crestor

20/05/2003 8:03am

UK Regulatory


RNS Number:3019L
AstraZeneca PLC
20 May 2003



CRESTOR(R) -- NEW DATA AND REGULATORY UPDATE



New Data



AstraZeneca announced today that an updated review of the safety profile for
CRESTOR(R) (rosuvastatin) 10-40mg in over 15,000 patients, will be presented as
a poster at the 2nd annual meeting of the Asia Pacific Scientific Forum, in
Honolulu; June 8-10, 2003.  The abstract, which covers data as of October, 2002,
will be available online today via the conference website at:  
http://www.americanheart.org/presenter.jhtml?identifier=3000411



The data confirm the benefit-risk profile of CRESTOR, with the authors
concluding that: 'Compared with other statins, rosuvastatin 10-40mg is highly
beneficial in terms of lipid profiles and goal attainment with a reassuring
safety profile.'



Regulatory Update



The US Food and Drug Administration (FDA) today confirmed that CRESTOR will be
reviewed by the FDA's Endocrinologic and Metabolic Advisory Committee on July 9,
2003.  AstraZeneca is confident in the regulatory package submitted for CRESTOR
and looks forward to presenting data from the extensive clinical trial program,
confirming its efficacy and safety.



CRESTOR was first approved in the Netherlands in 2002 and has now successfully
completed the Mutual Recognition Procedure in 13 other European countries.
CRESTOR is awaiting approval in the US, Japan and other markets.  Launches in
Canada, the Netherlands and the UK have occurred, and further launches are
scheduled, following national marketing authorisations and pricing and
reimbursement discussions.



20 May 2003



Media Enquiries:

Emily Denney, Tel: +44 (0) 207 304 5034

Steve Brown, Tel: +44 (0) 207 304 5033



Investor Relations:

Mina Blair Robinson, Tel: +44 (0) 207 304 5084

Jonathan Hunt, Tel:  +44 (0) 207 304 5087



-Ends-




                      This information is provided by RNS
            The company news service from the London Stock Exchange
END

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