Invirase
Withdrawn
This medicine's authorisation has been withdrawn
saquinavir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 16 August 2023, the European Commission withdrew the marketing authorisation for Invirase (saquinavir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Roche Registration GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Invirase was granted marketing authorisation in the EU on 4 October 1996 for the treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was granted unlimited validity in 2006.
The European Public Assessment Report (EPAR) for Invirase is updated to indicate that the marketing authorisation is no longer valid.
Invirase : EPAR - Summary for the public
English (EN) (190.67 KB - PDF)
First published: Last updated:
български (BG) (275.76 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
español (ES) (193.02 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
čeština (CS) (237.45 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
dansk (DA) (188.78 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
Deutsch (DE) (199.88 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
eesti keel (ET) (182.53 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
ελληνικά (EL) (288.57 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
français (FR) (197.57 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
hrvatski (HR) (223.26 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
italiano (IT) (190.65 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
latviešu valoda (LV) (240.33 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
lietuvių kalba (LT) (229.19 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
magyar (HU) (215.94 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
Malti (MT) (250.91 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
Nederlands (NL) (195.17 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
polski (PL) (231.77 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
português (PT) (193.26 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
română (RO) (234.06 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
slovenčina (SK) (229.56 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
slovenščina (SL) (224.18 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
Suomi (FI) (186.69 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
svenska (SV) (190.32 KB - PDF)
First published: 01/12/2008Last updated: 25/09/2023
Product information
Invirase : EPAR - Product Information
English (EN) (2.32 MB - PDF)
First published: Last updated:
български (BG) (3.04 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
español (ES) (2.3 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
čeština (CS) (2.53 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
dansk (DA) (2.34 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
Deutsch (DE) (2.51 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
eesti keel (ET) (2.1 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
ελληνικά (EL) (3.33 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
français (FR) (2.41 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
hrvatski (HR) (2.5 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
íslenska (IS) (2.64 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
italiano (IT) (2.55 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
latviešu valoda (LV) (2.88 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
lietuvių kalba (LT) (2.68 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
magyar (HU) (2.58 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
Malti (MT) (2.86 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
Nederlands (NL) (2.33 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
norsk (NO) (2.25 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
polski (PL) (3.25 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
português (PT) (2.27 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
română (RO) (2.91 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
slovenčina (SK) (2.52 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
slovenščina (SL) (2.48 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
Suomi (FI) (2.33 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
svenska (SV) (2.22 MB - PDF)
First published: 08/04/2009Last updated: 25/09/2023
Latest procedure affecting product information:
N/0139
10/03/2023
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).
Invirase : EPAR - All Authorised presentations
English (EN) (59.87 KB - PDF)
First published: Last updated:
български (BG) (78.96 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
español (ES) (60.68 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
čeština (CS) (114.55 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
dansk (DA) (60.48 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
Deutsch (DE) (59.9 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
eesti keel (ET) (62.07 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
ελληνικά (EL) (80.34 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
français (FR) (60.7 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
hrvatski (HR) (107.85 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
íslenska (IS) (75.34 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
italiano (IT) (75.57 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
latviešu valoda (LV) (66.85 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
lietuvių kalba (LT) (78.09 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
magyar (HU) (82.58 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
Malti (MT) (77.3 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
Nederlands (NL) (60.41 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
norsk (NO) (60.91 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
polski (PL) (128.88 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
português (PT) (63.05 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
română (RO) (72.48 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
slovenčina (SK) (75.36 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
slovenščina (SL) (74.96 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
Suomi (FI) (57.99 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
svenska (SV) (59.77 KB - PDF)
First published: 31/10/2006Last updated: 25/09/2023
Product details
- Name of medicine
- Invirase
- Active substance
- saquinavir
- International non-proprietary name (INN) or common name
- saquinavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE01
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.
Authorisation details
- EMA product number
- EMEA/H/C/000113
- Marketing authorisation holder
- Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany - Opinion adopted
- 23/07/2009
- Marketing authorisation issued
- 03/10/1996
- Withdrawal of marketing authorisation
- 16/08/2023
- Revision
- 50
Assessment history
Invirase : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (3.81 MB - PDF)
First published: Last updated:
Invirase-H-C-113-P46-54 : EPAR - Assessment Report
AdoptedReference Number: EMA/129533/2013
English (EN) (299.64 KB - PDF)
First published: Last updated:
Invirase-H-C-113-A20-88 : EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/58070/2011
English (EN) (823.18 KB - PDF)
First published: Last updated:
Invirase-H-C-113-II-85: EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/623173/2010
English (EN) (668.93 KB - PDF)
First published: Last updated:
Invirase-H-C-113-II-62 : EPAR - Assessment Report - Variation
English (EN) (100.65 KB - PDF)
First published: Last updated:
Invirase-H-C-113-X-43 : EPAR - Assessment Report - Extension
English (EN) (688.77 KB - PDF)
First published: Last updated:
Invirase : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (237.23 KB - PDF)
First published: Last updated:
Committee for medicinal products for human use, summary of positive opinion for Lamivudine Teva
Reference Number: EMEA/CHMP/436960/2009
English (EN) (57.42 KB - PDF)
First published: Last updated:
Invirase : EPAR - Scientific Discussion
English (EN) (1.07 MB - PDF)
First published: Last updated:
Invirase : EPAR - Procedural steps taken before authorisation
English (EN) (134.5 KB - PDF)
First published: Last updated:
News on Invirase
More information on Invirase
Questions and answers on the review of Invirase (saquinavir)
Reference Number: EMEA/H/C/113/A-20/0088
English (EN) (58.34 KB - PDF)
First published: Last updated:
This page was last updated on