Approvals/HSA/APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

Approved

THERAPEUTIC

APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

Pfizer Ireland Pharmaceuticals🇸🇬 Health Sciences Authority

Approval Date: Nov 30, 2022
Approval ID: 647e8c4e8ab12893
Company: Pfizer Ireland Pharmaceuticals
Type: Therapeutic

Approval Details

Approval Id: 647e8c4e8ab12893
Drug Name: APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
Product Name: APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
Approval Number: SIN16648P
Approval Date: 2022-11-30
Registrant: PFIZER PRIVATE LIMITED
Licence Holder: PFIZER PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SUSPENSION
Dosage: **4.2. Posology and method of administration** Posology _Individuals 18 years of age and older_ Apexxnar is to be administered as a single dose to individuals 18 years of age and older. The need for revaccination with a subsequent dose of Apexxnar has not been established. No data on sequential vaccination with other pneumococcal vaccines or a booster dose are available for Apexxnar. Based on the clinical experience with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar), if the use of 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23 \[PPSV23\]) is considered appropriate, Apexxnar should be given first (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Apexxnar in children and adolescents younger than 18 years of age have not been established. No data are available. _Special populations_ There are no data with Apexxnar in special populations. Limited experience from clinical studies with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar) are available in adults at higher risk of pneumococcal infection either immunocompromised individuals or following bone marrow transplantation (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Based on these data the following posology was recommended for Prevenar 13: - Individuals at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection), including those previously vaccinated with 1 or more doses of PPSV23, were recommended to receive at least 1 dose of Prevenar 13. - In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series with Prevenar 13 consisted of 4 doses of 0.5 mL each. The primary series consisted of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose was recommended 6 months after the third dose (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Please also refer to sections 4.4. and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Method of administration For intramuscular use only. One dose (0.5 mL) of Apexxnar should be administered intramuscularly, preferably in the deltoid muscle, with care to avoid injection into or near nerves and blood vessels. For instructions on the handling of the vaccine before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Route Of Administration: INTRAMUSCULAR
Indication Info: **4.1. Therapeutic indications** Active immunisation for the prevention of invasive disease and pneumonia caused by _Streptococcus pneumoniae_ in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Apexxnar should be used in accordance with official recommendations.
Contraindications: **4.3. Contraindications** Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_, or to diphtheria toxoid.
Atc Code: J07AL02
Atc Item Name: pneumococcus, purified polysaccharides antigen conjugated
Pharma Manufacturer Name: PFIZER PRIVATE LIMITED
Company Detail Path: /organization/95690f7e03ef4227/pfizer-private-limited

Active Ingredients

Pneumococcal polysaccharide serotype 12F (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 15B (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 7F (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 23F (conjugate)

2.2 μg/0.5ml

CRM197 protein

Approx. 51 μg/0.5ml

Pneumococcal polysaccharide serotype 33F (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 5 (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 1 (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 3 (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 6B (conjugate)

4.4 μg/0.5ml

Pneumococcal polysaccharide serotype 6A (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 14 (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 4 (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 19F (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 19A (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 18C (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 22F (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 9V (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 11A (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 10A (conjugate)

2.2 μg/0.5ml

Pneumococcal polysaccharide serotype 8 (conjugate)

2.2 μg/0.5ml

CRM197 PROTEIN

APPROX. 51 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B (CONJUGATE)

4.4 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 (CONJUGATE)

2.2 ΜCG/0.5 ML

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V (CONJUGATE)

2.2 ΜCG/0.5 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 30, 2022

Approval ID

647e8c4e8ab12893

Type

Therapeutic

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