Misoone – Medicinal Product Register of Latvia

Misoprostolum

Search by the name of the active substance

Return to the results

Medicinal product name

Misoone 400 micrograms tablets

Pharmaceutical form

Tablet

Strength

400 micrograms

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
13-0015-01	N1	Is available

Legal status

Rx Prescription (Pr.II stac., gin.)

Summary of product characteristics

03-11-2020

Package leaflet

22-02-2022

Risk minimisation measures

Izglītojošie materiāli ārstam

Izglītojošie materiāli pacientam

Vēstule veselības aprūpes speciālistam

ATC code

G02AD06 – Other gynecologicals

Medicinal products (8)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Is available (according to the information provided by wholesalers) (56 containers)	ELVIM	N1 (400 µg)	OPA/Al/PVC/Al unit-dose blister	€ 24.57	13-0015-01	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N4 (400 µg)	OPA/Al/PVC/Al unit-dose blister		13-0015-02	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N16 (400 µg)	OPA/Al/PVC/Al unit-dose blister		13-0015-03	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N40 (400 µg)	OPA/Al/PVC/Al unit-dose blister		13-0015-04	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (400 µg)	PVC/PCTFE aluminium unit-dose blister		13-0015-05	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N4 (400 µg)	PVC/PCTFE aluminium unit-dose blister		13-0015-06	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N16 (400 µg)	PVC/PCTFE aluminium unit-dose blister		13-0015-07	Labelling text Nov 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N40 (400 µg)	PVC/PCTFE aluminium unit-dose blister		13-0015-08	Labelling text Nov 3, 2020

Registration information

Marketing authorisation No.	13-0015
Date of authorisation	Feb 13, 2013
Marketing authorisation holder, country	Exelgyn, France

Return to the results

Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on Apr 17, 2024.