Desloratadine Teva
desloratadine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Desloratadine Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine Teva.
Authorisation details
Product details | |
---|---|
Name |
Desloratadine Teva
|
Agency product number |
EMEA/H/C/002419
|
Active substance |
desloratadine
|
International non-proprietary name (INN) or common name |
desloratadine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
R06AX27
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Teva B.V
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
24/11/2011
|
Contact address |
Swensweg 5
2031GA Haarlem The Netherlands |
Product information
30/05/2022 Desloratadine Teva - EMEA/H/C/002419 - PSUSA/00000962/202107
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antihistamines for systemic use
Therapeutic indication
Desloratadine Teva is indicated for the relief of symptoms associated with:
- allergic rhinitis;
- urticaria.