Vaccine 122A _ 122B

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Vaccine 122A _ 122B Powered By Docstoc
					SL.   NAME OF INDIAN OVERSEASE            NAME       OF COMPOSITION             INDICATION    PERMISSION    PERMISSION
NO.   COMPANY.        MANUFACTURER        PRODUCT                                             NO            DATE
                      COMPANY
1     GlaxoSmithKline Glaxosmithkline     Oral             Each      0.1ml      For     active Import       04.09.2008
      Pharmaceuticals (GSK) Biologicals   Poliomyelitis    dose (2 drops)       immunization 964/08
      Asia Pvt. Ltd., S.A, Belgium.       Type 3 Vaccine   contains:            against
      Patiala Road,                       (Monovalent).    Poliomyelitis        Poliomyelitis
      Nabha 147201,                                        viruse type – 3      Type 3
      Punjab.                                              at least 105.8
                                                           CCID50
                                                           (Strain-Sabin)



2     GlaxoSmithKline Glaxosmithkline     Oral             Each 0.1ml dose      For     active Import      - 04.09.2008
      Pharmaceuticals (GSK) Biologicals   Poliomyelitis    (2         drops)    immunization 965/08
      Asia Pvt. Ltd., S.A, Belgium.       Type 1 Vaccine   contains             against
      Patiala   Road,                     (Monovalent)     Poliomyelitis        Poliomyelitis
                                                           virus type 1 at
      Nabha 147201,                                                             Type 1
                                                           least        106.0
      Punjab.
                                                           CCID50.
3   GlaxoSmithKline Glaxosmithkline Human             Each 0.5ml dose      It is indicated Import   30/9/2008
    Pharmaceuticals (GSK) Biologicals Papilomavirus   contains:-           in      females 955/08
    Asia Pvt. Ltd., S.A, Belgium.     Vaccine         Human                from      10-45
    Patiala   Road,                                   Papilomavirus        years of age
                                                      type         16L1,
    Nabha 147201,                                                          for          the
                                                      Protein    -    20
    Punjab.                                                                prevention of
                                                      microgram,
                                                      Human                cervical
                                                      Papilomavirus        cancer        by
                                                      type         18L1,   protecting
                                                      Protein    -    20   against
                                                      micrograms           incideence
                                                                           and persistent
                                                                           infection,
                                                                           Cytogenical
                                                                           abonormality
                                                                           including      a
                                                                           typical
                                                                           squamous cell
                                                                           of
                                                                           undetermine
                                                                           significance
                                                                           and     cervical
                                                                           intraepithelial
                                                                           neo       plasia
                                                                           (CIN), CIN 1
                                                                           and          pre
                                                                           cancerous
                                                                           lesions (CIN 2
                                                                           and CIN 3)
4   Novartis          Novartis vaccines   Oral              Each      0.1ml For       active Import   04.09.2008
    helathcare Pvt. and Diagnostics /     Poliomyelitis     dose (2 drops) immunization 961/08
    Ltd.,     Sandoz siena, Italy.        Type 1 Vaccine    contains:         against
    House,                                (Monovalent).     Poliomyelitis     Poliomyelitis
    Shivsagar                             (For     Unicef   virus type – 1 Type 1.
    Estate,      Dr.                      only)             at least 10
                                                                          6.0

    Annie    Beasant                                        CCID50 (Strain-
    Road,      Worli,                                       Sabin).
    Mumbai         –
    400018.

5   Novartis          Novartis vaccines   Oral              Each      0.1ml For       active Import   04.09.2008
    helathcare Pvt. and Diagnostics /     Poliomyelitis     dose (2 drops) immunization 962/08
    Ltd.,     Sandoz siena, Italy.        Type 3 vaccine    contains:         against
    House,                                (Monovalent).     Poliomyelitis     Poliomyelitis
    Shivsagar                             (For     Unicef   virus type – 1 Type 3.
    Estate,      Dr.                      only)             at least 10
                                                                          5.8

    Annie    Beasant                                        CCID50 (Strain-
    Road,      Worli,                                       Sabin).
    Mumbai         –
    400018.
6   Novartis          Novartis vaccines   Oral            Each 0.1ml dose       For         active Import 963/08   04.09.2008
    helathcare Pvt. and Diagnostics /     Poliomyelitis   (2         drops)     immunization
    Ltd.,     Sandoz siena, Italy.        Type 1, Type 2, contains:
                                                                                against
    House,                                &     Type    3 Poliomyelitis         Poliomyelitis
                                                          virus type 1 – at
    Shivsagar                             vaccine                               Type 1, Type 2 &
                                                          least        106.0
    Estate,      Dr.                      (Trivalent)                           Type 3.
                                                           CCID50
    Annie    Beasant
                                                           Poliomyelitis
    Road,      Worli,                                      virus type 1 – at
    Mumbai         –
                                                           least        105.0
    400018                                                 CCID50
                                                           Poliomyelitis
                                                           virus type 1 – at
                                                           least        105.5
                                                           CCID50 (Strain-
                                                           Sabin)
7   Roche       Scintific   Chugai           Tocilizumab.   Each vial of 4ml /   For the disease Import–930/08   29.08.2008
    Company      (India)    pharmaceutical                  10ml / 20ml /        which do not
    Pvt. Ltd., 165, Dr.     company limited,                contains:            show sufficient
    A.B.Road,     Worli,    Tokyo, Japan.                   Toclizumab       –   response to the
    Mumbai – 400018.                                        20mg/ml.             existing
                                                                                 therapies:- e.g.
                                                                                 Rheumatoid
                                                                                 arhtritis
                                                                                 (Including
                                                                                 inhibition        of
                                                                                 progression       of
                                                                                 structural     joint
                                                                                 damage),
                                                                                 Polyarticular-
                                                                                 course juvenile
                                                                                 idiopathic
                                                                                 arthritis.
                                                                                 Improvent         of
                                                                                 various
                                                                                 symptoms (e.g.
                                                                                 generalised
                                                                                 fatigue)        and
                                                                                 laboratory
                                                                                 findings
                                                                                 (Increased        C-
                                                                                 reactive protein,
                                                                                 fibrinogen, and
                                                                                 erythrocyte
8   Shreya Life Sciences Sandoz        GmbH Recombinant       (1) Powder for       Long          term Import 966/08   05.09.2008
    Pvt. Ltd., Shreya Biochemister,         Human    Growth   Injection: Each      treatment        of
                                                              vial         after
    House,        301/A, Kundl, Austria.    Hormone.                               children       who
                                                              reconstitution
    Pereira Hill Road,                                                             have        growth
                                                              contains
    Andheri (E), Mumbai                                       Recombinant          failure due to
    – 400099.                                                 Human Growth         endogenous
                                                              Hormone 5.8mg.       growth hormone
                                                              (2) Solution for     and     for     the
                                                              injection: Each      treatement       of
                                                              cartidge of 1.5ml
                                                                                   short steature in
                                                              contains
                                                              Recombinant          children       with
                                                              Human Growth         turner’s
                                                              Hormone      5mg     syndrome
                                                              (15IU) and 10mg      conmfirmed by
                                                              (30IU).              chromosomal
                                                                                   analysis.
9    Sanofi Pasture India Sanofi       Pasture   Combination       of   Each 0.5ml dose       For the active Import 877/08       21.08.2008
     Pvt. Ltd., D-2, Fourth limited,  Ontario,   Tetanus Toxoids +      contains: Tetanus     immunization
                                                                                              against
     Floor,       Southern Toronto, Canada.      Diptheria Toxoids      Toxoids – 5Lf,
                                                                                              Tetanus,
     Park,             DDA                       Component              Diptheria Toxoids
                                                                                              Diptheria  and
     Commercial Center,                          Pertusis Vaccine.      – 2Lf, Pertusis       Pertusis.
     Saket, New Delhi -                                                 Toxoids – 2.5mcg,
     110017                                                             Fimbrial
                                                                        Agglutiongens
                                                                        2+3 – 5mcg,
                                                                        Filamentous
                                                                        Haemagglutinin –
                                                                        5mcg, Pertactin
                                                                        (PRN) – 3mcg


10   Sanofi Pasteur India Sanofi       Pasture, Oral Poliomyelitis      Each 0.1ml dose       For         active Import 717/08   30.06.2008
     Pvt. Ltd., D-2, Fourth Lyon, France        Type 1 Vaccine          (2 drops) contains    immunization
     Floor,       Southern                      (Monovalent).           Poliomyelitis virus   against
     Park,             DDA                                              type 1 at least       Poliomyelitis type
     Commercial Center,                                                 106.0 CCID50.         1.
     Saket, New Delhi -
     110017
11   Sudershan Biotech     Beijing       Four Recombinant        Each      prefilled For           the IMP-42/08     17.01.2008
     Limited, 4-100, C/9   Rings              Human              syringe contains: r-treatement      of
                           Biopharmaceutica
     & C/10, L.B. Nagar,                      Granulocyte        Human               neutrophilic
                           ls Co. Ltd, China.
     Hyderabad         –                      Colony Stimulating Granulocyte         granulocytopenia
     500074.                                  Factor Injection. Colony               reduced        by
                                                                 Stimulating Factor chemotherapy of
                                                                 –                   cancer and bone
                                                                 75mcg/150mcg/3 marrow
                                                                 00mcg.              transplantation.

12   Reliance               Nova Laboratories, Recombinant       Each     prefilled   For the treatment IMP-177/08   30.01.2008
     Biopharmaceuticals UK.                    Human             syringe contains     of anemia due to
     Pvt. Ltd., R-282, TTC,                    Erythropoietin    Recombinant          chronic       renal
     Industrial      Area,                     Injection         Human                failure patients.
     Thane – Belapur                                             Erythropoietin
     Road, Rebale, Navi                                          10,000 IU/ml.
     Mumbai – 400701.

				
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