This medicinal product is permitted for use in sport.

This product is currently under assessment and awaiting additional information on the substance(s)in this medicinal product.

All Therapeutic Use Exemption applications MUST be accompanied by a medical file reflecting current bestmedical practice to include:
1) A complete medical history
2) Copies of all relevant examinations and clinical notes (for example, if a clinic visit is referencedin a letter or summary, a copy of the clinical notes taken during the visit must be included)
3) Copies of laboratory results/reports, and imaging studies4) Exact name, speciality, address (including telephone, e-mail, fax) of examining physician
For asthma TUE applications, the medical file should also specifically include:
5) A comprehensive report of the clinical examination with specific focus on the respiratory system
6) A report of spirometry with the flow volume curve and the measure of the Forced Expiratory Volume in 1 second (FEV1)
7) If airway obstruction is present, the spirometry will be repeated after inhalation of a shortacting beta-2 agonist to demonstrate the reversibility of bronchoconstriction
8) In the absence of reversible airway obstruction, a bronchial provocation test is required toestablish the presence of airway hyperresponsiveness
9) If the athlete reapplies for a TUE that has expired, the application should include documentation that confirms the initial diagnosis as well as the reports and pulmonary function tests from regular asthma follow-up visits.

Depending on the route of administration, this medicinal product contains substance(s) which may be either (1) Prohibited in-competition for use in sport (Athletes requesting to use this product are required adhere to the Sport Ireland TUE Policy) or (2) Permitted.

This medicinal product contains substance(s) prohibited for use in
sport, in men only. Male athletes requesting to use this product are required to adhere to the Sport Ireland Therapeutic Use Exemption Policy.

This medicinal product contains Salmeterol. Salmeterol is permitted when used
by inhalation up to a maximum of 200 micrograms over 24 hours. Athletes requesting to use Salmeterol in excess of 200 micrograms over 24 hours must have must have a medical
file in place and may require a Therapeutic Use Exemption. .

This medicinal product contains Formoterol. From 2013, Formoterol is permitted when used to a maximum inhaled dose of 54 micrograms over 24 hours. Athletes requesting to use formoterol by inhalation at doses in excess 54 mcg over 24 hours must have a medical file in place and may require a Therapeutic Use Exemption. For turbohaler devices, only 75% of the labelled dose is inhaled. Therefore, a turbohaler device labelled as containing 6 microgram of formoterol results in the inhalation of 4.5 microgram of formoterol.For Flutiform inhaler approximately 90% of the dose is delivered. Therefore, a Flutiform inhaler device labelled as containing 10 microgram of formoterol results in the inhalation of 9 microgram of formoterol.
The presence in urine of formoterol in excess of 40 ng/mL is not consistent with therapeutic use of the substance and will be considered as an Adverse Analytical Finding (AAF) unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of a therapeutic dose (by inhalation) up to the maximum dose indicated above.

A Retroactive Therapeutic Use Exemption (TUE) is a TUE approved by a TUE Committee based on a documented medical file after a laboratory has reported an Adverse Analytical Finding (AAF).

This medicinal product contains substance(s) prohibited in sport during the competition period only. Athletes requesting to use this product in-competition are required to adhere to the Sport Ireland Therapeutic Use Exemption Policy

This medicinal product contains Salbutamol. Salbutamol is permitted when used by inhalation to a maximal dose of 1600 micrograms over 24 hours in divided doses; not to exceed 600 micrograms in 8 hours starting from any dose. Athletes requesting to use salbutamol by inhalation at doses in excess of 1600 micrograms over 24 hours, or in excess of 600 micrograms in 8 hours, must have a medical
file in place and may require a Therapeutic Use Exemption. The presence of salbutamol in urine in excess of 1000 ng/mL is not consistent with therapeutic use of the substance and will be considered as an Adverse Analytical Finding (AAF) unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of the use of a therapeutic dose (by inhalation) up to the maximum dose indicated above.

This medicinal product contains vilanterol. Vilanterol is permitted when used by inhalation to a maximum dose of 25 micrograms over 24 hours. One puff corresponds to a pre-dispensed dose of 25 micrograms vilanterol. Athletes requesting to use vilanterol by inhalation at doses in excess of 25 micrograms (one puff) over 24 hours must have a medical file in place and may require a Therapeutic Use Exemption.

This medicinal product contains substance(s) prohibited for use in specific sports
only (as listed in WADA Prohibited List). Athletes requesting to use this product in these specific sports are required to adhere to the Sport Ireland Therapeutic Use Exemption Policy.

This medicinal product contains substance(s) prohibited for
use in sport. Athletes seeking to use this product are required to adhere to the Sport Ireland Therapeutic Use Exemption Policy.