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- Zoledronic acid Mylan
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Zoledronic acid Mylan
This product is authorized under a different brandname in the EU in the folowing languages:
- Zoledronsyre Mylan (DA)
- Zoledronsäure Mylan (DE)
- Ácido zoledrónico Mylan (ES)
- Acide zolédronique Mylan (FR)
- Zoledronsav Mylan (HU)
- Acido zoledronico Mylan (IT)
- Zoledroninezuur Mylan (NL)
- Ácido Zoledrónico Mylan (PT)
- Zolendronska kislina Mylan (SL)
|
| Auth. number : | EU/1/12/786 |
| INN : | zoledronic acid |
| ATC: | M - Musculo-skeletal system M05 - Drugs for treatment of bone diseases M05B - Drugs affecting bone structure and mineralization M05BA - Biphosphonates M05BA08 - Zoledronic acid (See WHO ATC Index) |
| Indication: |
|
| Marketing Authorisation Holder: | Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France |
EPAR and active package presentations
Package presentations
|
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. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 27/08/2012 | Centralised - Authorisation | EMEA/H/C/2482 | (2012)6033 of 23/08/2012 | |||
| 17/01/2013 | Centralised - Variation | EMEA/H/C/2482/IB/1 | ||||