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Propecia
Press Release: Merck Sharp & Dohme Limited
Monday 25th October, 1999
Merck Sharp & Dohme Limited (MSD) has received marketing authorisation for PROPECIA (finasteride 1 mg) from the UK Medicines Control Agency (MCA). PROPECIA is currently available in 38 other countries including the USA, France, Germany and Switzerland.
The licensed indication for PROPECIA in the UK is for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.
Male pattern hair loss is a significant disorder with a defined pathology that is easily recognisable in adult men and has important consequences - usually social. It is clear from the clinical data, and experts agree, that the treatment is effective and can increase scalp hair count and density in a cosmetically significant manner.
PROPECIA is not indicated for women and children.
MSD is delighted to have received marketing authorisation for PROPECIA and confirmation that the regulatory authorities find that PROPECIA meets the agency's high standards of safety, quality and efficacy.
The current arrangements for pricing and reimbursement of pharmaceutical products in the UK mean that PROPECIA is automatically reimbursed by the Government and could be made available immediately through the NHS. However, the company does not believe that it would be appropriate for PROPECIA to be prescribed at the expense of the National Health Service (NHS). Therefore, MSD has decided not to make PROPECIA available immediately until it is clear how and by whom it will be paid for.
In all other markets in which it is available, PROPECIA is prescribed privately and is not reimbursed by national governments or paid for out of the public purse. MSD's preference in the UK is for private prescribing of which Schedule 10 of the NHS (General Medical Services) Regulations 1992* is one option.
The company has commenced discussions with the Secretary of State and hopes that early, open and constructive discussions will lead to reasonable and appropriate positioning for PROPECIA in the UK market.
Information about the availability of PROPECIA in the UK will be the subject of a separate announcement once these discussions are concluded.