Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, United Kingdom
Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for prolonged-release suspension for injection. Powder: White to slightly yellow powder. Solvent: Clear solution. |
One vial of powder contains 11.25 mg of triptorelin, as triptorelin embonate.
After reconstitution in the 2 mL solvent, the reconstituted solution contains 11.25 mg of triptorelin, as triptorelin embonate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Triptorelin |
Triptorelin is a decapeptide analogue of GnRH which initially stimulates release of pituitary gonadotropins. |
| List of Excipients |
|---|
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Powder: Poly (D, L-lactide-co-glycolide) Solvent: Water for injection |
Powder in 6 ml Type I colourless glass vial with grey bromobutyl stopper and aluminium flip-off capsule and 2 ml of solvent in Type I colourless glass ampoule, and a kit of 1 empty injection syringe of polypropylene and 2 injection needles (one with safety device for injection and one without safety device for reconstitution).
Ipsen Limited, 190 Bath Road, Slough, Berkshire, SL1 3XE, United Kingdom
PL 034926/0012
Date of first authorisation: 19 November 2007
Date of latest renewal: 09 June 2011
| Drug | Countries | |
|---|---|---|
| SALVACYL | Austria, France, Ireland, Netherlands, Poland, United Kingdom |
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