Rasilamlo

RSS
Withdrawn

This medicine's authorisation has been withdrawn

aliskiren hemifumarate / amlodipine besilate
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 25 June 2015, the European Commission withdrew the marketing authorisation for Rasilamlo (aliskiren / amlodipine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Rasilamlo was granted marketing authorisation in the EU on 14 April 2011 for treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. The product had not been marketed in the EU since 2014. The European Public Assessment Report (EPAR) for Rasilamlo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

български (BG) (625.8 KB - PDF)

View

español (ES) (546.18 KB - PDF)

View

čeština (CS) (607.91 KB - PDF)

View

dansk (DA) (539.34 KB - PDF)

View

Deutsch (DE) (542.97 KB - PDF)

View

eesti keel (ET) (543.39 KB - PDF)

View

ελληνικά (EL) (631.27 KB - PDF)

View

français (FR) (543.76 KB - PDF)

View

hrvatski (HR) (560.79 KB - PDF)

View

italiano (IT) (543.57 KB - PDF)

View

latviešu valoda (LV) (580.24 KB - PDF)

View

lietuvių kalba (LT) (566.7 KB - PDF)

View

magyar (HU) (601.46 KB - PDF)

View

Malti (MT) (608.3 KB - PDF)

View

Nederlands (NL) (544.14 KB - PDF)

View

polski (PL) (607.28 KB - PDF)

View

português (PT) (544.93 KB - PDF)

View

română (RO) (565.23 KB - PDF)

View

slovenčina (SK) (603.83 KB - PDF)

View

slovenščina (SL) (598.36 KB - PDF)

View

Suomi (FI) (539.89 KB - PDF)

View

svenska (SV) (541.6 KB - PDF)

View

Product information

български (BG) (2.22 MB - PDF)

View

español (ES) (1.71 MB - PDF)

View

čeština (CS) (1.97 MB - PDF)

View

dansk (DA) (1.49 MB - PDF)

View

Deutsch (DE) (1.53 MB - PDF)

View

eesti keel (ET) (1.6 MB - PDF)

View

ελληνικά (EL) (2.23 MB - PDF)

View

français (FR) (1.8 MB - PDF)

View

hrvatski (HR) (1.79 MB - PDF)

View

íslenska (IS) (1.56 MB - PDF)

View

italiano (IT) (1.69 MB - PDF)

View

latviešu valoda (LV) (1.89 MB - PDF)

View

lietuvių kalba (LT) (1.83 MB - PDF)

View

magyar (HU) (2.04 MB - PDF)

View

Malti (MT) (2.2 MB - PDF)

View

Nederlands (NL) (1.52 MB - PDF)

View

norsk (NO) (1.58 MB - PDF)

View

polski (PL) (2.23 MB - PDF)

View

português (PT) (1.64 MB - PDF)

View

română (RO) (1.8 MB - PDF)

View

slovenčina (SK) (2.04 MB - PDF)

View

slovenščina (SL) (2.09 MB - PDF)

View

Suomi (FI) (1.59 MB - PDF)

View

svenska (SV) (1.51 MB - PDF)

View
25/06/2015
icon globe

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).

български (BG) (584.44 KB - PDF)

View

español (ES) (527.6 KB - PDF)

View

čeština (CS) (565.61 KB - PDF)

View

dansk (DA) (524.84 KB - PDF)

View

Deutsch (DE) (525.6 KB - PDF)

View

eesti keel (ET) (528.71 KB - PDF)

View

ελληνικά (EL) (583.39 KB - PDF)

View

français (FR) (527.52 KB - PDF)

View

íslenska (IS) (523.15 KB - PDF)

View

italiano (IT) (526.02 KB - PDF)

View

latviešu valoda (LV) (575.03 KB - PDF)

View

lietuvių kalba (LT) (555.41 KB - PDF)

View

magyar (HU) (570.27 KB - PDF)

View

Malti (MT) (567.84 KB - PDF)

View

Nederlands (NL) (525.68 KB - PDF)

View

norsk (NO) (524.48 KB - PDF)

View

polski (PL) (553.74 KB - PDF)

View

português (PT) (526.54 KB - PDF)

View

română (RO) (554.03 KB - PDF)

View

slovenčina (SK) (569.32 KB - PDF)

View

slovenščina (SL) (540.77 KB - PDF)

View

Suomi (FI) (526.26 KB - PDF)

View

svenska (SV) (524.35 KB - PDF)

View

Product details

Name of medicine
Rasilamlo
Active substance
  • aliskiren
  • amlodipine
International non-proprietary name (INN) or common name
  • aliskiren hemifumarate
  • amlodipine besilate
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA53

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.

Authorisation details

EMA product number
EMEA/H/C/002073
Marketing authorisation holder
Novartis Europharm Ltd

Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Marketing authorisation issued
14/04/2011
Withdrawal of marketing authorisation
25/06/2015
Revision
7

Assessment history

български (BG) (87.49 KB - PDF)

View

español (ES) (50.51 KB - PDF)

View

čeština (CS) (82.81 KB - PDF)

View

dansk (DA) (49.01 KB - PDF)

View

Deutsch (DE) (53.54 KB - PDF)

View

eesti keel (ET) (50.6 KB - PDF)

View

ελληνικά (EL) (89.54 KB - PDF)

View

français (FR) (51.91 KB - PDF)

View

hrvatski (HR) (80.12 KB - PDF)

View

italiano (IT) (51.13 KB - PDF)

View

latviešu valoda (LV) (81.63 KB - PDF)

View

lietuvių kalba (LT) (82.54 KB - PDF)

View

magyar (HU) (68.7 KB - PDF)

View

Malti (MT) (84.23 KB - PDF)

View

Nederlands (NL) (49.82 KB - PDF)

View

polski (PL) (83.62 KB - PDF)

View

português (PT) (49.74 KB - PDF)

View

română (RO) (88.19 KB - PDF)

View

slovenčina (SK) (81.5 KB - PDF)

View

slovenščina (SL) (79.79 KB - PDF)

View

Suomi (FI) (49.15 KB - PDF)

View

svenska (SV) (50.18 KB - PDF)

View

This page was last updated on

Share this page