Overview
The marketing authorisation for Sprimeo HCT has been withdrawn at the request of the marketing-authorisation holder.
Sprimeo HCT : EPAR - Summary for the public
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Product information
Sprimeo HCT : EPAR - Product Information
English (EN) (1.91 MB - PDF)
български (BG) (4.72 MB - PDF)
español (ES) (1.87 MB - PDF)
čeština (CS) (3.27 MB - PDF)
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italiano (IT) (1.94 MB - PDF)
latviešu valoda (LV) (3.49 MB - PDF)
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Malti (MT) (3.66 MB - PDF)
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norsk (NO) (2.01 MB - PDF)
polski (PL) (3.61 MB - PDF)
português (PT) (1.88 MB - PDF)
română (RO) (2.05 MB - PDF)
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slovenščina (SL) (3.4 MB - PDF)
Suomi (FI) (1.86 MB - PDF)
svenska (SV) (1.85 MB - PDF)
Latest procedure affecting product information: -
06/07/2012
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).
Sprimeo HCT : EPAR - All Authorised presentations
English (EN) (451.36 KB - PDF)
български (BG) (544.13 KB - PDF)
español (ES) (455.93 KB - PDF)
čeština (CS) (481.57 KB - PDF)
dansk (DA) (451.09 KB - PDF)
Deutsch (DE) (460.1 KB - PDF)
eesti keel (ET) (456.43 KB - PDF)
ελληνικά (EL) (565.21 KB - PDF)
français (FR) (462.9 KB - PDF)
íslenska (IS) (455.05 KB - PDF)
italiano (IT) (455.29 KB - PDF)
latviešu valoda (LV) (488.67 KB - PDF)
lietuvių kalba (LT) (466.48 KB - PDF)
magyar (HU) (514.93 KB - PDF)
Malti (MT) (488.16 KB - PDF)
Nederlands (NL) (456.23 KB - PDF)
norsk (NO) (456.64 KB - PDF)
polski (PL) (484.36 KB - PDF)
português (PT) (455.22 KB - PDF)
română (RO) (464.08 KB - PDF)
slovenčina (SK) (483.52 KB - PDF)
slovenščina (SL) (494.28 KB - PDF)
Suomi (FI) (457.04 KB - PDF)
svenska (SV) (454.24 KB - PDF)
Product details
- Name of medicine
- Sprimeo HCT
- Active substance
- aliskiren
- hydrochlorothiazide
- International non-proprietary name (INN) or common name
- aliskiren
- hydrochlorothiazide
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09XA52
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
Treatment of essential hypertension in adults.
Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.
Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Authorisation details
- EMA product number
- EMEA/H/C/002421
- Marketing authorisation holder
- Novartis Europharm Ltd.
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom - Marketing authorisation issued
- 23/06/2011
Assessment history
Sprimeo HCT : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (334.59 KB - PDF)
Sprimeo HCT-H-C-2421-A20-11 : EPAR - Assessment Report
English (EN) (492.12 KB - PDF)
News on Sprimeo HCT
More information on Sprimeo HCT
Public statement on Sprimeo HCT: Withdrawal of the marketing authorisation in the European Union
English (EN) (52.86 KB - PDF)
Questions and answers on the review aliskiren-containing medicines
English (EN) (60.98 KB - PDF)
Questions and answers on ongoing review of aliskiren-containing medicines
English (EN) (65.3 KB - PDF)