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PREZISTA(R)(darunavir) Oral Suspension Receives European Commission Approval For Young Children With HIV-1 Infection

Before taking darunavir, patients should tell their doctor if they have any medical conditions, including liver problems, including hepatitis B or C, diabetes, symptoms of infections, change in body fat, haemophilia, musculoskeletal problems, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing.

Darunavir should not be used in patients allergic (hypersensitive) to it or ritonavir or with severe liver problems.

Due to potential drug interactions, patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others. Please see full Summary of Product Characteristics for more details.

About Janssen in HIV - Commitment to Innovative Research & Development

Over the last five years, Janssen has launched three therapies for people living with HIV. Janssen has a long heritage in HIV and is committed to innovation in HIV therapies.  Janssen is constantly striving for improvements in efficacy, safety and dosing simplification and is committed to evaluating HIV treatments for a broad range of patients-from treatment-naïve to treatment-experienced-with the goal of helping all patients achieve an undetectable viral load and a better quality of life.

More information about Janssen can be found at http://www.janssen-emea.com  

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica NVand/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2011.  Copies of this Form 10-K, as well as subsequent filings, are available online at  http://www.sec.gov,  http://www.jnj.com   or on request from Johnson & Johnson.  Neither Janssen Pharmaceutica NV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

References

  1. Janssen. Data on File. Beerse. 2012
  2. NAM AIDSmap. 'One in eight European children with HIV experienced failure of three drug classes within five years.' Available at URL: http://www.aidsmap.com/One-in-eight-European-children-with-HIV-experienced-failure-of-three-drug-classes-within-five-years/page/1777790/. Last accessed August 17, 2012.

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