Overview
The marketing authorisation for Invirase (SRD) has been withdrawn at the request of the marketing-authorisation holder.
Invirase : EPAR - Summary for the public
English (EN) (190.67 KB - PDF)
български (BG) (275.76 KB - PDF)
español (ES) (193.02 KB - PDF)
čeština (CS) (237.45 KB - PDF)
dansk (DA) (188.78 KB - PDF)
Deutsch (DE) (199.88 KB - PDF)
eesti keel (ET) (182.53 KB - PDF)
ελληνικά (EL) (288.57 KB - PDF)
français (FR) (197.57 KB - PDF)
hrvatski (HR) (223.26 KB - PDF)
italiano (IT) (190.65 KB - PDF)
latviešu valoda (LV) (240.33 KB - PDF)
lietuvių kalba (LT) (229.19 KB - PDF)
magyar (HU) (215.94 KB - PDF)
Malti (MT) (250.91 KB - PDF)
Nederlands (NL) (195.17 KB - PDF)
polski (PL) (231.77 KB - PDF)
português (PT) (193.26 KB - PDF)
română (RO) (234.06 KB - PDF)
slovenčina (SK) (229.56 KB - PDF)
slovenščina (SL) (224.18 KB - PDF)
Suomi (FI) (186.69 KB - PDF)
svenska (SV) (190.32 KB - PDF)
Product information
Invirase : EPAR - Product Information
English (EN) (2.32 MB - PDF)
български (BG) (3.04 MB - PDF)
español (ES) (2.3 MB - PDF)
čeština (CS) (2.53 MB - PDF)
dansk (DA) (2.34 MB - PDF)
Deutsch (DE) (2.51 MB - PDF)
eesti keel (ET) (2.1 MB - PDF)
ελληνικά (EL) (3.33 MB - PDF)
français (FR) (2.41 MB - PDF)
hrvatski (HR) (2.5 MB - PDF)
íslenska (IS) (2.64 MB - PDF)
italiano (IT) (2.55 MB - PDF)
latviešu valoda (LV) (2.88 MB - PDF)
lietuvių kalba (LT) (2.68 MB - PDF)
magyar (HU) (2.58 MB - PDF)
Malti (MT) (2.86 MB - PDF)
Nederlands (NL) (2.33 MB - PDF)
norsk (NO) (2.25 MB - PDF)
polski (PL) (3.25 MB - PDF)
português (PT) (2.27 MB - PDF)
română (RO) (2.91 MB - PDF)
slovenčina (SK) (2.52 MB - PDF)
slovenščina (SL) (2.48 MB - PDF)
Suomi (FI) (2.33 MB - PDF)
svenska (SV) (2.22 MB - PDF)
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)
български (BG) (78.96 KB - PDF)
español (ES) (60.68 KB - PDF)
čeština (CS) (114.55 KB - PDF)
dansk (DA) (60.48 KB - PDF)
Deutsch (DE) (59.9 KB - PDF)
eesti keel (ET) (62.07 KB - PDF)
ελληνικά (EL) (80.34 KB - PDF)
français (FR) (60.7 KB - PDF)
hrvatski (HR) (107.85 KB - PDF)
íslenska (IS) (75.34 KB - PDF)
italiano (IT) (75.57 KB - PDF)
latviešu valoda (LV) (66.85 KB - PDF)
lietuvių kalba (LT) (78.09 KB - PDF)
magyar (HU) (82.58 KB - PDF)
Malti (MT) (77.3 KB - PDF)
Nederlands (NL) (60.41 KB - PDF)
norsk (NO) (60.91 KB - PDF)
polski (PL) (128.88 KB - PDF)
português (PT) (63.05 KB - PDF)
română (RO) (72.48 KB - PDF)
slovenčina (SK) (75.36 KB - PDF)
slovenščina (SL) (74.96 KB - PDF)
Suomi (FI) (57.99 KB - PDF)
svenska (SV) (59.77 KB - PDF)
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 - Marketing authorisation issued
- 03/10/1996
- Revision
- 50
Assessment history
Invirase : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (3.81 MB - PDF)
Invirase-H-C-113-P46-54 : EPAR - Assessment Report
English (EN) (299.64 KB - PDF)
Invirase-H-C-113-A20-88 : EPAR - Assessment Report - Article 20
English (EN) (823.18 KB - PDF)
Invirase-H-C-113-II-85: EPAR - Assessment Report - Variation
English (EN) (668.93 KB - PDF)
Invirase-H-C-113-II-62 : EPAR - Assessment Report - Variation
English (EN) (100.65 KB - PDF)
Invirase-H-C-113-X-43 : EPAR - Assessment Report - Extension
English (EN) (688.77 KB - PDF)
Invirase : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (237.23 KB - PDF)
Committee for medicinal products for human use, summary of positive opinion for Lamivudine Teva
English (EN) (57.42 KB - PDF)
Invirase : EPAR - Scientific Discussion
English (EN) (1.07 MB - PDF)
Invirase : EPAR - Procedural steps taken before authorisation
English (EN) (134.5 KB - PDF)
News on Invirase
More information on Invirase
Questions and answers on the review of Invirase (saquinavir)
English (EN) (58.34 KB - PDF)
More information on Invirase
Public statement on Invirase : Withdrawal of the marketing authorisation in the European Union
English (EN) (115.9 KB - PDF)