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PRODUCT DETAIL

Toletate

Code 2007E
MA number 56/0243/22-S
Product Form: imp sip 2x10,72 mg(striek.inj.napl.plast.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L02 ENDOCRINE THERAPY
L02A HORMONES AND RELATED AGENTS
L02AE Gonadotropin releasing hormone analogues
L02AE02 Leuprorelin
Shelf life: 48
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 19.09.2022
Validity: 19.09.2027
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Toletate_imp sip_09_2022.pdf  
PIL: PIL_Toletate_imp sip_09_2022.pdf  
Safety feature Yes
Data update: 21.09.2022
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