PRODUCT DETAIL

Terlipresín EVER Pharma 0,2 mg/ml injekčný roztok

Code

1407C

MA number

84/0460/16-S

Product Form:

sol inj 1x5 ml (liek.inj.skl.)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Decentralised

Therapeutic Class:

84 - VASOPRESSORICA

ATC:

H	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01BA	Vasopressin and analogues
H01BA04	Terlipressin

Shelf life:

Container:

colourless glass vial (type 1), rubber stopper (type 1)

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(3) hybrid application
MA issued:	26.10.2016
Pediatric warnings:	Yes
SPC:	SPC_Terlipressin Ever_06_2023.pdf
PIL:	PIL_Terlipresín EVER Pharma 0,2 mg-ml injekčný roztok_10_2023.pdf
Safety feature	Yes
Data update:	31.01.2022