Overview
The marketing authorisation for Prevenar has been withdrawn at the request of the marketing authorisation holder.
Prevenar : EPAR - Summary for the public
English (EN) (528.26 KB - PDF)
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español (ES) (592.52 KB - PDF)
čeština (CS) (660.97 KB - PDF)
dansk (DA) (589.87 KB - PDF)
Deutsch (DE) (594.56 KB - PDF)
eesti keel (ET) (589.41 KB - PDF)
ελληνικά (EL) (658.73 KB - PDF)
français (FR) (530.73 KB - PDF)
italiano (IT) (595.31 KB - PDF)
latviešu valoda (LV) (665.62 KB - PDF)
lietuvių kalba (LT) (621.09 KB - PDF)
magyar (HU) (592.78 KB - PDF)
Malti (MT) (599.24 KB - PDF)
Nederlands (NL) (591.92 KB - PDF)
polski (PL) (663.02 KB - PDF)
português (PT) (590.65 KB - PDF)
română (RO) (560.42 KB - PDF)
slovenčina (SK) (598.72 KB - PDF)
slovenščina (SL) (652.35 KB - PDF)
Suomi (FI) (604.43 KB - PDF)
svenska (SV) (529.2 KB - PDF)
Product information
Prevenar : EPAR - Product Information
English (EN) (984.79 KB - PDF)
български (BG) (2.09 MB - PDF)
español (ES) (974.43 KB - PDF)
čeština (CS) (1.69 MB - PDF)
dansk (DA) (964.06 KB - PDF)
Deutsch (DE) (1006.15 KB - PDF)
eesti keel (ET) (970.35 KB - PDF)
ελληνικά (EL) (2.18 MB - PDF)
français (FR) (1001.22 KB - PDF)
hrvatski (HR) (1003.1 KB - PDF)
íslenska (IS) (959.52 KB - PDF)
italiano (IT) (966.42 KB - PDF)
latviešu valoda (LV) (1.75 MB - PDF)
lietuvių kalba (LT) (953.77 KB - PDF)
magyar (HU) (1.72 MB - PDF)
Malti (MT) (1.82 MB - PDF)
Nederlands (NL) (980.06 KB - PDF)
norsk (NO) (954.16 KB - PDF)
polski (PL) (1.76 MB - PDF)
português (PT) (976.58 KB - PDF)
română (RO) (977.43 KB - PDF)
slovenčina (SK) (1.72 MB - PDF)
slovenščina (SL) (1.68 MB - PDF)
Suomi (FI) (964.73 KB - PDF)
svenska (SV) (970.69 KB - PDF)
Latest procedure affecting product information: PSUSA/00002452/201408
22/06/2015
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).
Prevenar : EPAR - All Authorised presentations
English (EN) (472.82 KB - PDF)
български (BG) (567.28 KB - PDF)
español (ES) (473.69 KB - PDF)
čeština (CS) (559.34 KB - PDF)
dansk (DA) (475.95 KB - PDF)
Deutsch (DE) (470.88 KB - PDF)
eesti keel (ET) (470.04 KB - PDF)
ελληνικά (EL) (590.57 KB - PDF)
français (FR) (471.54 KB - PDF)
hrvatski (HR) (494.31 KB - PDF)
italiano (IT) (473.23 KB - PDF)
latviešu valoda (LV) (556.77 KB - PDF)
lietuvių kalba (LT) (544.45 KB - PDF)
magyar (HU) (558.63 KB - PDF)
Malti (MT) (560.67 KB - PDF)
Nederlands (NL) (473.47 KB - PDF)
polski (PL) (578.01 KB - PDF)
português (PT) (474.39 KB - PDF)
română (RO) (547.27 KB - PDF)
slovenčina (SK) (529.46 KB - PDF)
slovenščina (SL) (512.61 KB - PDF)
Suomi (FI) (472.84 KB - PDF)
svenska (SV) (473.39 KB - PDF)
Product details
- Name of medicine
- Prevenar
- Active substance
- pneumococcal oligosaccharide serotype 18C
- Pneumococcal polysaccharide serotype 19F
- Pneumococcal polysaccharide serotype 23F
- Pneumococcal polysaccharide serotype 4
- Pneumococcal polysaccharide serotype 6B
- Pneumococcal polysaccharide serotype 9V
- Pneumococcal polysaccharide serotype 14
- International non-proprietary name (INN) or common name
- pneumococcal saccharide conjugated vaccine, adsorbed
- Therapeutic area (MeSH)
- Pneumococcal Infections
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07AL02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.
Authorisation details
- EMA product number
- EMEA/H/C/000323
- Marketing authorisation holder
- Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom - Marketing authorisation issued
- 02/02/2001
- Revision
- 23
Assessment history
Prevenar-H-C-PSUSA-00002452-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (527.72 KB - PDF)
Prevenar-H-C-323-P46-0130 : EPAR - Assessment Report
English (EN) (1.06 MB - PDF)
Prevenar-H-C-323-P46-0132 : EPAR - Assessment Report
English (EN) (2.48 MB - PDF)
Prevenar-H-C-323-P46-0129 : EPAR - Assessment Report
English (EN) (1.05 MB - PDF)
Prevenar-H-C-323-II-76 : EPAR - Scientific Discussion - Variation
English (EN) (635.94 KB - PDF)
Prevenar-H-C-323-II-80 : EPAR - Scientific Discussion - Variation
English (EN) (673.49 KB - PDF)
Prevenar : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (563.25 KB - PDF)
More information on Prevenar
Public statement on Prevenar (pneumococcal polysaccharide conjugate vaccine (7-valent, adsorbed)): Withdrawal of the marketing authorisation in the European Union
English (EN) (59.59 KB - PDF)