Consumers and health professionals are advised that the shortage of clomifene 50 mg tablets (also known as clomiphene and marketed in Australia as Clomid) has been extended.
The sponsor, Sanofi-Aventis Australia, has advised the TGA that this product is expected to be available again after 30 September 2019.
Please note that Serophene has been discontinued by the sponsor and was removed from the market on 3 October 2016.
Alternative product available
The TGA has granted a section 19A approval for the import and supply of an alternative product Clomid (clomifene citrate) 50 mg tablets marketed in the Netherlands.
Pharmacies can obtain the alternative Dutch product by ordering the product in the normal manner through the wholesaler, using the same wholesaler codes. For enquiries relating to supply, contact Sanofi Customer Service on 1800 640 791.
Any adverse events involving the Dutch product should be reported directly to Sanofi at ae@sanofi.com or to the TGA (see below for further information).
Please note Sanofi is no longer supplying the previously approved alternative French product Clomid (clomifene citrate) 50 mg tablets.
Update 2 - continuing medicine shortage
25 January 2017
Consumers and health professionals are advised that the shortage of clomifene 50 mg tablets (also known as clomiphene and marketed in Australia as Clomid) has been extended.
The sponsor, Sanofi-Aventis Australia, has advised the TGA that this product is expected to be available again after 30 June 2017.
For information about alternative supply arrangements, please see 'Alternative product available' below.
Please note that Serophene has been discontinued by the sponsor and was removed from the market on 3 October 2016.
Update - medicine shortages - alternative product available
24 January 2016
Consumers and health professionals are advised that there is a shortage of clomifene 50 mg tablets (also known as clomiphene), which are marketed in Australia as Clomid and Serophene.
Clomifene is used in the treatment of ovulatory failure in patients who wish to become pregnant.
Clomid is currently experiencing a shortage due to manufacturing issues, and is not expected to be available until 31 December 2016.
Serophene will be out-of-stock by end of June-July 2016 due to technical manufacturing issues. As a result of ongoing technical manufacturing and supply issues with the contract manufacturer for Serophene, the sponsor has decided to discontinue this product.
Alternative product available
The TGA has granted a section 19A approval for the import and supply of an alternative French product Clomid (clomifene citrate) 50 mg tablets.
Pharmacies can obtain the alternative French product Clomid (clomifene citrate) 50 mg tablets by ordering the product in the normal manner through the wholesaler, using the same wholesaler codes. For enquiries relating to supply, contact Sanofi Customer Service on 1800 640 791
Any adverse events involving the French product Clomid (clomifene citrate) 50 mg tablets should be reported directly to Sanofi at ae@sanofi.com or to the TGA (see below for further information).
Information for consumers
If you have been prescribed Clomid or Serophene, please see your health professional for further advice.
Information for health professionals
The TGA has worked with sponsors to arrange supply of alternative clomifene products (see above).
For information on the Medicine Shortages Information Initiative (medicine.shortages@tga.gov.au) or the Special Access Scheme (sas@tga.gov.au) please contact the TGA via email or call 1800 020 653.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.