- 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Assessment Report (EPAR) for Rasilamlo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Rasilamlo : EPAR - Summary for the public
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čeština (CS) (607.91 KB - PDF)
dansk (DA) (539.34 KB - PDF)
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eesti keel (ET) (543.39 KB - PDF)
ελληνικά (EL) (631.27 KB - PDF)
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hrvatski (HR) (560.79 KB - PDF)
italiano (IT) (543.57 KB - PDF)
latviešu valoda (LV) (580.24 KB - PDF)
lietuvių kalba (LT) (566.7 KB - PDF)
magyar (HU) (601.46 KB - PDF)
Malti (MT) (608.3 KB - PDF)
Nederlands (NL) (544.14 KB - PDF)
polski (PL) (607.28 KB - PDF)
português (PT) (544.93 KB - PDF)
română (RO) (565.23 KB - PDF)
slovenčina (SK) (603.83 KB - PDF)
slovenščina (SL) (598.36 KB - PDF)
Suomi (FI) (539.89 KB - PDF)
svenska (SV) (541.6 KB - PDF)
Product information
Rasilamlo : EPAR - Product Information
English (EN) (1.71 MB - PDF)
български (BG) (2.22 MB - PDF)
español (ES) (1.71 MB - PDF)
čeština (CS) (1.97 MB - PDF)
dansk (DA) (1.49 MB - PDF)
Deutsch (DE) (1.53 MB - PDF)
eesti keel (ET) (1.6 MB - PDF)
ελληνικά (EL) (2.23 MB - PDF)
français (FR) (1.8 MB - PDF)
hrvatski (HR) (1.79 MB - PDF)
íslenska (IS) (1.56 MB - PDF)
italiano (IT) (1.69 MB - PDF)
latviešu valoda (LV) (1.89 MB - PDF)
lietuvių kalba (LT) (1.83 MB - PDF)
magyar (HU) (2.04 MB - PDF)
Malti (MT) (2.2 MB - PDF)
Nederlands (NL) (1.52 MB - PDF)
norsk (NO) (1.58 MB - PDF)
polski (PL) (2.23 MB - PDF)
português (PT) (1.64 MB - PDF)
română (RO) (1.8 MB - PDF)
slovenčina (SK) (2.04 MB - PDF)
slovenščina (SL) (2.09 MB - PDF)
Suomi (FI) (1.59 MB - PDF)
svenska (SV) (1.51 MB - PDF)
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).
Rasilamlo : EPAR - All Authorised presentations
English (EN) (522.88 KB - PDF)
български (BG) (584.44 KB - PDF)
español (ES) (527.6 KB - PDF)
čeština (CS) (565.61 KB - PDF)
dansk (DA) (524.84 KB - PDF)
Deutsch (DE) (525.6 KB - PDF)
eesti keel (ET) (528.71 KB - PDF)
ελληνικά (EL) (583.39 KB - PDF)
français (FR) (527.52 KB - PDF)
íslenska (IS) (523.15 KB - PDF)
italiano (IT) (526.02 KB - PDF)
latviešu valoda (LV) (575.03 KB - PDF)
lietuvių kalba (LT) (555.41 KB - PDF)
magyar (HU) (570.27 KB - PDF)
Malti (MT) (567.84 KB - PDF)
Nederlands (NL) (525.68 KB - PDF)
norsk (NO) (524.48 KB - PDF)
polski (PL) (553.74 KB - PDF)
português (PT) (526.54 KB - PDF)
română (RO) (554.03 KB - PDF)
slovenčina (SK) (569.32 KB - PDF)
slovenščina (SL) (540.77 KB - PDF)
Suomi (FI) (526.26 KB - PDF)
svenska (SV) (524.35 KB - PDF)
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 systemTherapeutic 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
Rasilamlo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (957.74 KB - PDF)
Rasilamlo-H-C-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation
English (EN) (554.55 KB - PDF)
Rasilamlo-H-C-2073-A31-84 : EPAR - Assessment Report - Article 31
English (EN) (976.52 KB - PDF)
Rasilamlo-H-C-2073-A31-84 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommen...
English (EN) (527.75 KB - PDF)
български (BG) (87.49 KB - PDF)
español (ES) (50.51 KB - PDF)
čeština (CS) (82.81 KB - PDF)
dansk (DA) (49.01 KB - PDF)
Deutsch (DE) (53.54 KB - PDF)
eesti keel (ET) (50.6 KB - PDF)
ελληνικά (EL) (89.54 KB - PDF)
français (FR) (51.91 KB - PDF)
hrvatski (HR) (80.12 KB - PDF)
italiano (IT) (51.13 KB - PDF)
latviešu valoda (LV) (81.63 KB - PDF)
lietuvių kalba (LT) (82.54 KB - PDF)
magyar (HU) (68.7 KB - PDF)
Malti (MT) (84.23 KB - PDF)
Nederlands (NL) (49.82 KB - PDF)
polski (PL) (83.62 KB - PDF)
português (PT) (49.74 KB - PDF)
română (RO) (88.19 KB - PDF)
slovenčina (SK) (81.5 KB - PDF)
slovenščina (SL) (79.79 KB - PDF)
Suomi (FI) (49.15 KB - PDF)
svenska (SV) (50.18 KB - PDF)
Rasilamlo-H-C-2073-PSUV-90 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (530.15 KB - PDF)
Rasilamlo H-C-2073-A20-16 : EPAR - Assessment Report - Variation
English (EN) (907.71 KB - PDF)
Rasilamlo-H-C-2073-WS-169 : EPAR - Assessment Report - Variation
English (EN) (673.48 KB - PDF)
News on Rasilamlo
More information on Rasilamlo
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)