Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
Active substances:
|
|
ATC code:
|
R02AA82
|
Dosage form:
|
lozenge
|
Strength:
|
3mg+1mg
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated June 30, 2023)
|
Package information leaflet (PIL):
|
EST (last updated June 30, 2023)
|
Translation of package information leaflet into Russian:
|
RUS (last updated July 24, 2018)
|
Translation of package information leaflet into English:
|
ENG (last updated July 24, 2018)
|
Labelling:
|
(last updated July 24, 2018)
|
Indication:
|
lemon and elder flower is indicated in adults, adolescents and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis and pharyngitis.
|
Safety features:
|
No
|
Marketing authorization holder:
|
KRKA d.d. Novo mesto
|
Marketing authorization number:
|
952817
|
Marketing authorization issued on:
|
October 11, 2017
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
(last updated October 11, 2017)
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1722877
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
lozenge
|
3mg +1mg 8TK
|
OTC
|
|
|
|
|
|
1722888
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
lozenge
|
3mg +1mg 16TK
|
OTC
|
|
|
27.11.2023
|
|
|
1722899
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
lozenge
|
3mg +1mg 24TK
|
OTC
|
|
|
|
|
|
1722901
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
lozenge
|
3mg +1mg 32TK
|
OTC
|
|
|
|
|
|
1722912
|
SEPTOLETE OMNI LEMON & ELDERFLOWER
|
lozenge
|
3mg +1mg 40TK
|
OTC
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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