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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/12/809|
|ATC:||Anatomical main group: G - Genito urinary system and sex hormones|
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BD - Urinary antispasmodics
Chemical substance: G04BD12 - Mirabegron
(See WHO ATC Index)
|Indication:||Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.|
|Marketing Authorisation Holder:||Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|07/01/2013||Centralised - Authorisation||EMEA/H/C/2388||(2012)9945 of 20/12/2012|
|19/02/2013||Centralised - Variation||EMEA/H/C/2388/IAin/1/G|