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HSA Approval

CRAVIT OPHTHALMIC SOLUTION 0.5% w/v

SIN11826P

CRAVIT OPHTHALMIC SOLUTION 0.5% w/v

CRAVIT OPHTHALMIC SOLUTION 0.5% w/v

February 28, 2002

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANTEN PHARMACEUTICAL ASIA PTE. LTD.
Licence HolderSANTEN PHARMACEUTICAL ASIA PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**\[Dosage and Administration\]** Usually, instill 1 drop a time 3 times daily. The dosage may be adjusted according to the patient's symptoms.

OPHTHALMIC

Medical Information

**\[Indications\]** The following infections caused by levofloxacin-susceptible strains of _Staphylococcus_ sp., _Streptococcus_ sp., _Streptococcus pneumoniae_, _Micrococcus_ sp., _Enterococcus_ sp., _Corynebacterium_ sp., _Pseudomonas_ sp., _Pseudomonas aeruginosa_, _Haemophilus_ sp. ( _H. influenzae, H. aegyptius_ \[ _Koch-Weeks bacillus_\]), _Moraxella_ ( _Branhamella_) _catarrhalis_, _Moraxella_ sp. ( _Morax-Axenfeld bacillus_), _Serratia_ sp., _Klebsiella_ sp., _Proteus_ sp., _Acinetobacter_ sp., _Enterobacter_ sp,. _Propionibacterium acnes_ : Blepharitis, hordeolum, dacryocystitis, conjunctivitis, tarsadenitis, keratitis, corneal ulcer, and postoperative infections.

**\[Contraindications\] (Cravit ophthalmic solution is contraindicated in the following patients.)** Patients with a history of hypersensitivity to the ingredient of this product, Ofloxacin or any quinolone antibiotics.

S01AX19

xs 01 ax 19

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Santen Pharmaceutical Co., Ltd (Noto Plant)

Active Ingredients

LEVOFLOXACIN HYDRATE

0.5% w/v

Levofloxacin

Documents

Package Inserts

CV_SG_BN_PI_191029.pdf

Approved: March 19, 2020

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