F8 Applications - 75 & 76

JJ Evans made this Rhyddid Gwybodaeth request to Commission on Human Medicines

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

Roedd y cais yn rhannol lwyddiannus.

Dear Commission on Human Medicines,

Please supply copies of all Factor VIII Product License Applications received in 1975 & 1976.

Yours faithfully,

JJ Evans

MHRA Customer Services, Commission on Human Medicines

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dangos adrannau a ddyfynnir

MHRA Customer Services, Commission on Human Medicines

Our Ref: FOI 18/618

Dear Mr Evans

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 19 November 2018.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [Commission on Human Medicines request email]
Stay connected: mhra.gov.uk/stayconnected

dangos adrannau a ddyfynnir

FOILicensing, Commission on Human Medicines

Dear Mr Evans

 

Thank you for your information request dated 19th November 2018 where you
asked The Commission on Human Medicines for copies of all Factor VIII
Product License Applications received in 1975 & 1976.

 

The Commission on Human Medicines (CHM) advises on the safety, efficacy
and quality of applications for product licenses for medicinal products
and does not receive applications for product licenses. Therefore, in our
response we have assumed that you mean the Medicines and Healthcare
Products Agency (MHRA). Our records show that an application for Factor
VIII PL 00231/0038 was granted to CSL Behring UK on 25th March 1976. This
licence was later cancelled on 6th October 1986. In addition, an
application for Humanate AHF concentrate for injection 250 % 500 IU/vial
was granted to Ipsen Biopharm Limited on 27th August 1976. This licence
was later cancelled on 15th September 1986.

 

Unfortunately, I am unable to provide copies of the licence applications
for either of the 2 products as we do not hold them.

 

If you have any queries, please reply to this email.

 

Yours sincerely,

 

Licensing Division

 

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