Ribavirin Teva Pharma B.V.
ribavirin
Table of contents
Overview
The marketing authorisation for Ribavirin Teva Pharma B. V. has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Ribavirin Teva Pharma B.V.
|
| Agency product number |
EMEA/H/C/001064
|
| Active substance |
Ribavirin
|
| International non-proprietary name (INN) or common name |
ribavirin
|
| Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
| Anatomical therapeutic chemical (ATC) code |
J05AP01
|
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 | |
|---|---|
| Marketing-authorisation holder |
Teva B.V.
|
| Revision |
14
|
| Date of issue of marketing authorisation valid throughout the European Union |
01/07/2009
|
| Contact address |
Swensweg 5 |
Product information
22/06/2021 Ribavirin Teva Pharma B.V. - EMEA/H/C/001064 - IA/0023
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
Antivirals for systemic use
Therapeutic indication
Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of
chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of
chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not
previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).