Approval / Acknowledgement Letter Ref No. / Diary no F.No.12-48/GSK/PAC- Synflorix/15-BD 25-Mar-15 2 GlaxoSmithKline Pharmaceuticals Limited.

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1 1 GlaxoSmithKline Deletion of a n-significant in-process test limit during the purification process of the tetanus / diphtheria toxoids used in the manufacture of GSK's PCV vaccine [brand name: Synflorix] F /GSK/PAC- Synflorix/15-BD 25-Mar-15 2 GlaxoSmithKline Application for a Post Approval Change in Biological Product - To reclassify fill volume controls from in-process control to process parameter/measurements with alert and action levels performed during the filling process of GSK's MMRV vaccine - Measles, mumps, rubella and varicella vaccine (live) Ph. Eur. F /GSK/PAC- MMRV/15-BD 25-Mar-15 3 GlaxoSmithKline 4 GlaxoSmithKline 5 GlaxoSmithKline Asia Private Application for a Post Approval Change in Biological Product - Introduction of a mir to the Quality Control (QC) procedures for the final container volume determination and update to the final target fill volume controls for the diluent Water for Injection used for GSK's MMRV vaccine - Measles, mumps, rubella and varicella vaccine (live) Ph. Eur. I Addition of Tuas-Singapore site for manufacturing and QC testing of adsorbed movalent conjugate bulk for the 10th serotype (PS-5) used in GSK s Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed) Ph. Eur.] [Brand Name: Synflorix] tification of a Post Approval Change in Biological Product - Deletion of a n-significant in-process test limit during the purification process of the tetanus toxoids used in the manufacture of GSK's Haemophilus Type b conjugated vaccine - Hib Vaccine (Brand Name: HIBERIX) F. NO /GSK/PAC- MMRV/15-BD 26-Mar-15 F /GSK/PAC- Synflorix/15-BD 28-Apr-15 F /GSK/PAC- Hibrix /15-BD 26-Jun-15

2 6 GlaxoSmithKline tification of Level Post Approval Changes for GSK's HBV vaccine - Hepatitis B Virus (rdna) Vaccine IP [Engerix B Paediatric/ Adult] - Correction of the compendial references to the analytical methods mentioned in the registration dossier 1. The purity by Sodium Dodecyl Sulphate Drug Substance: HBsAg PolyAcrylamide Gel Electrophoresis (SDS-PAGE) 2. The aluminium identity testing method for Aluminium Hydroxide gel or Al(OH)3 F /GSK/PAC- Rotarix/15-BD 01-Oct-15 7 GlaxoSmithKline Asia Private 8 GlaxoSmithKline Asia Private 9 GlaxoSmithKline tification of Post Approval Change (Level ) in Biological Product Reduction of PRN load on Q-Sepharose column Vaccines Impacted: - Diphtheria Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [Infanrix ] - Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, reduced antigens content) Ph. Eur. [Boostrix ] tification of a Post Approval Change for GSK's Human Rotavirus Vaccine (HRV) - Rotavirus Vaccine (Live Attenuated, Oral) IP [Brand Name: Rotarix] Change in the name of the diluent manufacturing site (intermediate site) from Glaxo Wellcome NDB to Aspen NDB tification of a Post Approval Change for GSK's MMRV Vaccine - Measles, Mumps, Rubella and Varicella vaccine (live) Ph. Eur. [Brand Name: Priorix Tetra] Change in the name of the diluent manufacturing site (intermediate site) from Glaxo Wellcome NDB to Aspen NDB DCGI Diary v-15 F /GSK/PAC- Rotarix/16-BD 18-Dec-15 DCGI Diary Dec-15

3 10 GlaxoSmithKline Asia Private 11 GlaxoSmithKline Asia Private 12 GlaxoSmithKline 13 GlaxoSmithKline & Correction of the compendial references to the analytical methods mentioned in the registration dossier -The assay and loss on drying tests of dipotassiumphoshate trihydrate -The sterility test by direct iculation -The formaldehyde content by spectrophotometry -The aluminium identity testing method for Aluminium Hydroxide gel or Al(OH)3 Vaccine impacted: Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, reduced antigens content) Ph. Eur. [BOOSTRIX] Application for Post Approval Change in Biological Product - Addition of an additional freeze-dryer at the registered Fidia manufacturing site (FIDIA Farmaceutici S.p.a., Padova, Italy) for the production of GSK's Measles, Mumps and Rubella Vaccine (live) IP [MMR] tification of a Post Approval Change in Biological Product - Addition of building SG05 for n-sterile further purification steps of the tetanus & diphtheria toxoids used as carrier protein in manufacture of GSK's pneumococcal conjugated vaccine [brand name: Synflorix] Application for the below post approval s 1. Use of building Wavre rd 30 (WN30) at the GSK biologicals, Wavre, Belgium site as an additional facility for formulation 2. Addition of alternative container for DP intermediate storage 1. Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [HAV-HAB] 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP [HAV] F /GSK/PAC- Boostrix/15-BD 10-Jul-15 F /GSK/PAC- MMRV/15-BD 3-Aug-15 F /GSK/PAC- Synflorix/15-BD 17-Aug-15 F /GSK/PAC- Hep A&B/15-BD 1-Oct-15

4 14 GlaxoSmithKline 15 GlaxoSmithKline Asia Private Application for Post Approval Change in Biological Product - New reference standard for Hepatitis A antigen content by Enzyme Linked Immusorbent Assays (ELISA) and Potency hepatitis A antigen by ELISA assays performed as part of in process and QC release testing of the drug substance and during QC release testing Impacted vaccines: 1. Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [HAV-HAB] 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP [HAV] Application for Post Approval Change in Biological Product Use of building Wavre rd 30 (WN30) at the GSK Biologicals, Wavre, Belgium site as an additional facility for formulation of Human Papillomavirus Vaccine rdna Ph. Eur. [CERVARIX] F /GSK/PAC- Hep.A/15-BD 26-Oct-15 F /GSK/PAC- Cervarix/ 15-BD dated 01-Dec Dec-15

5 16 GlaxoSmithKline 17 GlaxoSmithKline Asia Private Application of Post Approval Change in Biological Product Revision of the vial rubber stoppers release specifications for various lyophilized and liquid vaccines Vaccines Impacted: Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed) Ph. Eur. [Synflorix ] Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] Varicella Vaccine, Live IP [Varilrix ] Inactivated Hepatitis A Vaccine (Adsorbed) IP [Havrix 1440 (Adult)/720 (Junior)] Poliomyelitis Vaccine (Inactivated) IP [Poliorix] Hepatitis B Vaccine (rdna) IP (Genetically Engineered) [Engerix B 20 mcg/1 ml (Adult) / Engerix B 10 mcg/0.5 ml (Paediatric)] Measles, Mumps, Rubella and Varicella vaccine (Live) Ph. Eur. [Priorix Tetra] Application of Post Approval Change in Biological Product Revision of the vial rubber stoppers release specifications for various lyophilized and liquid vaccines Vaccines Impacted: - Human Papillomavirus Vaccine rdna Ph Eur. [Cervarix ] - Rotavirus Vaccine (Live Attenuated, Oral) IP [Rotarix ] - Diphtheria Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [Infanrix ] - Haemophilus type b conjugated vaccine IP [Hiberix ] - Meningococcal Polysaccharide Vaccine IP [Mencevax ACWY] - Measles, Mumps and Rubella Vaccine (live) IP [Priorix ] - Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, reduced antigens content) Ph. Eur. F /GSK/PAC- Many Vaccines/15-BD 09-Sep-15 F /GSK/PAC- Many Vaccines/15-BD 09-Sep-15

6 [Boostrix ] 18 GlaxoSmithKline Asia Private 19 GlaxoSmithKline Asia Private 20 GlaxoSmithKline Asia Private & Application for approval of Post Approval Changes for GSK's HRV vaccine - Rotavirus Vaccine (Live Attenuated, Oral) IP [ROTARIX] - Correction of the compendial references to the analytical methods mentioned in the registration dossier 1. The sterility test Mycoplasma by culture 2. The assay and loss on drying tests of dipotassium phosphate trihydrate Application for Level Post Approval Change - Change in the retest period (or shelf-life) for the drug substance, involving: Extension of Shelf life of Diphtheria Tetanus (DT) concentrate from 24 months to 36 months Impacted GSK vaccines: Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, reduced antigens content) (dtpa) [Brand Name: BoostrixJ Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) (DTPa) [Brand Name: lnfanrix] Correction of the compendial references to the analytical methods mentioned in the registration dossier -The assay and loss on drying tests of dipotassiumphoshate trihydrate -The sterility test by direct iculation -The formaldehyde content by spectrophotometry -The aluminium identity testing method for Aluminium Hydroxide gel or Al(OH)3 Vaccine impacted: Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [INFANRIX] F /GSK/PAC- Rotarix/15-BD. 12-Feb-16 F /GSK/PAC- DT/15-BD 12-Feb-16 F /GSK/PAC- Infanrix/16-BD 16-Feb-16

7 21 GlaxoSmithKline Asia Private 22 GlaxoSmithKline 23 GlaxoSmithKline Asia Private Application for Post Approval Change in Biological Products - Replacement of dtpa reference vaccine used in mouse immugenicity assay for Acellular pertussis (Pa) antigens for GSK's dtpa vaccine - Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [Brand Name: BOOSTRIXJ tification of Level Post-approval : Decommission of packaging and labeling activities in Pre-filled Syringes in Building DR A/B located in Dresden, Germany 1. Hepatitis A Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP [Havrix Adult/Pediatric] Application for Post-Approval Change (Level ) in Biological Product - Change in the specification of raw material addition of a test of the foam breaking function of the antifoam emulsion used as a raw material 1. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [lnfanrix] 2. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced Antigens content) Ph. Eur. [Boostrix] F /GSK/PACdTpa/16-BD 19-Feb-16 F /GSK/PAC- MV /16-BD 8-Mar-16 F /GSK/PAC- Boostrix & Infanrix/ 16- BD 8-Mar-16

8 24 GlaxoSmithKline Asia Private 25 GlaxoSmithKline 26 GlaxoSmithKline Asia Private & Application for Post Approval Change in Biological Product Correction of the compendial references to the analytical methods mentioned in the registration dossier for GSK s HPV vaccine [brand name: Cervarix] 1. Sterility test Mycoplasma by culture 2. Purity by SDS-PAGE 3. Aluminium identity test for Al(OH)3 gel 4. Protein content by total nitrogen assay tification of Level Ill Post Approval Changes for GSK's HAB vaccine- Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] Introduction of the sterility tests by membrane filtration as Quality Control (QC) release test on adsorbed Hepatitis A antigen (ADFIHA) intermediate final bulk Introduction of the sterility tests by membrane filtration as Quality Control (QC) release test on adsorbed Hepatitis B antigen (HBsAg) concentrate (AHEF) intermediate final bulk Application for Post-Approval Change in Biological Product - Increase in the lifetime of the TFF membrane filter used in the manufacture of MPL powder, an excipient used in GSK s HPV Vaccine [brand name: Cervarix] F /GSK/PAC- HPV/16-BD dated 08- Mar Mar-16 F /GSK/PAC- HAB vaccine/16-bd 8-Mar-16 F /PAC- Cervarix/16-BD dated 08-Mar Mar-16

9 27 GlaxoSmithKline Asia Private 28 GlaxoSmithKline 29 GlaxoSmithKline I & tification of Level Post-approval : Decommission of packaging and labeling activities in Pre-filled Syringes in Building DR A/B located in Dresden, Germany 1. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [lnfanrix] 2. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced Antigens content) Ph. Eur. [Boostrix] Application for Post-Approval Changes (Level I & Level ) in Biological Product - Scale up of microfluidised PS5 and PS19F bulks and shelf-life extension of microfluidised PS5 used in the manufacture of GSK s pneumococcal vaccine (Synflorix) & Application for Post Approval Changes in Biological Product Correction of the compendial references to the analytical methods used in the testing of raw material for DS and DS intermediate for GSK s pneumococcal polysaccharide conjugate vaccine [brand name: Synflorix] -Dipotassium phosphate trihydrate (K2PO4.3H2O) -Purified Tetanus Toxoid (TT) bulk DCGI Diary Mar-16 F /GSK/PAC- Synflorix/ 16-BD 8-Apr-16 F /GSK/PAC- Synflorix/ 16-BD 8-Apr GlaxoSmithKline & Application for approval of Post Approval Changes for GSK's HAV vaccine - Inactivated Hepatitis A Vaccine (Adsorbed) IP (HAVRIX) - Correction of the compendial references to the analytical methods mentioned in the registration dossier 1. The sterility test Mycoplasma by culture 2. The aluminum identity testing method for Aluminum Hydroxide gel or Al(OH)3 3. The determination of formaldehyde content by spectrophotometry F /GSK/PAC- HAV/16-BD 11-Apr-16

10 31 GlaxoSmithKline Asia Private 32 GlaxoSmithKline 33 GlaxoSmithKline tification of a Level Ill Post Approval Change for Suppression of formulation, filling and lyophilization activities in RX.16.1 site for Vials in Rixensart, Belgium 1. Rotavirus Vaccine (Live Attenuated, Oral) IP [Rotarix] tification of a Level Ill Post Approval Change for Suppression of formulation, filling and lyophilization activities in RX.16.1 site for Vials in Rixensart, Belgium 1. Inactivated Hepatitis A Vaccine (Adsorbed) IP [Havrix Adult/Pediatric] 2. Poliomyelitis Vaccine (Inactivated) IP [Poliorix] & Application for Post Approval Changes in Biological Product - Change in description test and introduction of nephelometry on Hepatitis B surface antigen (HBsAg) bulk of GSK's Hepatitis B containing vaccines. Impacted vaccines: 1. Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [HAV-HAB] 2. Hepatitis B Virus (rdna) Vaccine IP [HBV] F /GSK/PAC- Rotavirus/16-BD 18-Apr-16 F /GSK/PAC- Hep-A, Polio/16-BD 18-Apr-16 F /GSK/PAC- Hepatitis/16-BD 25-Apr GlaxoSmithKline Asia Private (requiring CDL review) Application for Level Post-Approval Change Change in the re test period (or shelf Life) for the drug substance, involving: Extension of Shelf Life of PRN bulk from 24 months to 36 months. Impacted Vaccines: Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced Antigen Content) Ph. Eur. [Brand Name: BOOSTRIX] Diphtheria, Tetanus and Pertussis (Acellular Component) F /GSK/PAC - MV/16-BD 4-May-16

11 Vaccine (Adsorbed) Ph. Eur. [INFANRIX] 35 GlaxoSmithKline Asia Private Replacement of the current in-house working reference serum (WRS) used in the in vitro part of the potency assay (one-dose test) for the acellular Pertussis (Pa) components of Pa-containing vaccines Impacted Vaccines: Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced Antigen Content) Ph. Eur. [Brand Name: BOOSTRIX] Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [INFANRIX] F /GSK/PAC- Boostrix & Infanrix / 16- BD 4-May GlaxoSmithKline 37 GlaxoSmithKline Asia Private (requiring CDL review) Application for Post-Approval Change (Level ) in Biological Product Extension of shelf-life for GSK s pneumococcal polysaccharide conjugate vaccine (Synflorix) in Pre-Filled Syringe from 36 to 48months. tification of Post Approval Change (Level ) in Biological Product Introduction of the sterility test by membrane filtration as QC release test on ATTOAA intermediate used in the formulation of GSK s dtpa vaccine [brand name: Boostrix] F /GSK/PAC- Synflorix/ 16-BD 4-May-16 F /GSK/PAC- Boostrix/16-BD 13-May-16

12 38 GlaxoSmithKline & Application for Post-Approval Changes (Level and Level ) in Biological Product Removal of compendial references for analytical procedures o Sterility test Mycoplasma detection by culture method o Neomycin sulphate content by radial diffusion o Particle count test for diluent (WFI) Impacted vaccines: Measles, Mumps, Rubella and Varicella vaccine (Live) Ph. Eur. [Priorix Tetra] Varicella Vaccine, Live IP [Varilrix ] F /GSK/PAC- MMRV vaccine/ 16-BD 24-May GlaxoSmithKline Asia Private 40 GlaxoSmithKline 41 GlaxoSmithKline Asia Private & Application for Post-Approval Changes (Level and Level ) in Biological Product Removal of compendial references for analytical procedures used in GSK s MMR vaccine [brand name: Priorix] o Sterility test Mycoplasma detection by culture method o Neomycin sulphate content by radial diffusion o Particle count test for diluent (WFI) : tification of Post-Approval Change (Level ) in Biological Product - modification in the ph target and range used at the final ph adjustment during preparation of purified TT bulk, a carrier protein used in GSK s Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed) Ph. Eur. [brand name: SYNFLORIX] tification of Post-Approval Change (Level ) in Biological Product Introduction of BioReliance, Rockville, MD, USA as additional QC site responsible to conduct the Rabbit Pyrogen assay test for MPL powder, an excipient used in GSK s HPV vaccine [brand name: Cervarix] F /GSK/PAC- MMR vaccine/16-bd 24-May-16 F /GSK/PAC- Synflorix/16-BD 3-Jun-16 F /GSK/PAC- HPV /136-BD 15-Jun-16

13 42 GlaxoSmithKline Asia Private 43 GlaxoSmithKline 44 GlaxoSmithKline Application for Post-Approval Change (Level ) in Biological Product Change of source of raw material cystine for Tetanus - Marburg 1. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [lnfanrix) 2. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, Reduced Antigens content) Ph. Eur. [Boostrix) Application for Approval of a Level Post-Approval Change - Introduction of Maximum Storage Period for Hepatitis A (HAV) Iculum 1. Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP [Havrix Adult/Pediatric] & Application for approval of Post Approval Changes for GSK's HAB vaccine - Hepatitis A (Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] - Correction of the compendia} references to the analytical methods mentioned in the registration dossier 1. The sterility test Mycoplasma by culture 2. The purity by Sodium Dodecyl Sulphate PolyAcrylamide Gel Electrophoresis (SDS-PAGE) 3. The aluminum identity testing method for Aluminum Hydroxide gel or Al(OH)3 4. The determination of formaldehyde content by Spectrophotometry F /GSK/PAC- Boostrix & Infanrix/ 16- BD 27-Jun-16 F /GSK/PAC- Twinrix & Havrix/16-BD 8-Aug-16 F /GSK/PAC- HAV & HBV/ 16-BD 8-Aug-16

14 45 GlaxoSmithKline 46 GlaxoSmithKline 47 GlaxoSmithKline 48 GlaxoSmithKline 49 GlaxoSmithKline (requiring CDL review), but seeking approval and Application for Approval of a Level Post-Approval Change for correction of Compendial References to the Analytical methods mentioned in the Registration Dossier for GSK's HBV Containing Vaccines. Vaccine impacted: Hepatitis A Inactivated) and Hepatitis B (rdna) Vaccine (Adsorbed) IP [Twinrix Adult] Application for approval of Post-Approval Changes in Biological Product for GSK's Varicella vaccine [brand name: Varilrix] 1) Alignment of Varilrix table of composition in line with source country (Belgian) approval 2) Inclusion of the reference to Ph. Eur. mograph 0806 for Arginine Application for Post-Approval Change (Level ) in Biological Product Introduction of a shelf-life of 96 months at -196 C for the Varicella iculum used in the manufacturing process of GSK s MMRV and Varicella vaccines based on available stability data Vaccines Impacted: - MMRV vaccine [brand name: PRIORIX-TETRA] - Varicella vaccine [brand name: VARILRIX] Application for Post-Approval Changes (Level and Level ) in Biological Product - Change of specification for the antigenic activity performed at release and during stability evaluation of HBV bulk, a drug substance of GSK s HAB vaccine [brand name: TWINRIX ADULT] Application for Post-Approval Changes (Level ) Update to the description of QC release tests (Identity and Potency) performed during the manufacture of the rubella virus live attenuated bulk (DS) and on the final container (DP) F /GSK/PAC- Twinrix/16-BD 30-Aug-16 F /GSK/PAC- Varilrix/16-BD 30-Aug-16 F /GSK/PAC- MMRV & Varicella/ 16- BD 30-Aug-16 F /GSK/PAC- HAB/ 16-BD 22-Sep-16 F /GSK/PAC- MMRV I 16-BD 26-Sep-16

15 Vaccine Impacted: MMRV vaccine [brand name: PRIORIX-TETRA] 50 GlaxoSmithKline Asia Private 51 GlaxoSmithKline 52 GlaxoSmithKline Asia Private (requiring CDL review), category according to the guidance, category according to the guidance Application for Post-Approval Changes (Level ) Update to the description of QC release tests (Identity and Potency) performed during the manufacture of the rubella virus live attenuated bulk (DS) and on the final container (DP) Vaccine Impacted: MMR vaccine [brand name: PRIORIX] Application for Post Approval Changes (Level ) in Biological Product Update to the description within the registration files for internal controls, solutions and media Impacted vaccines: - Measles, Mumps, Rubella and Varicella Vaccine (Live) Ph. Eur. [Priorix-Tetra] - Varicella Vaccine, Live IP [Varilrix] Application for Post Approval Changes (Level ) in Biological Product Update to the description within the registration files for internal controls, solutions and media Impacted vaccine: - Measles, Mumps & Rubella Vaccine (Live) IP [Priorix] F /GSK/PAC- MMR/16-BD 26-Sep-16 F /GSK/PAC- MMRV & Varicella /16- BD 26-Sep-16 F /GSK/PAC- MMR/16-BD 26-Sep-16

16 53 GlaxoSmithKline Asia Private 54 GlaxoSmithKline Asia Private Application for Post-Approval Change (Level ) in Biological Product - Replacement of the current Pertactin (PRN) Reference Standard by a new proposed batch 1. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed, reduced antigens content) Ph. Eur. [brand name: BOOSTRIX] 2. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. [brand name: INFANRIX] tification of a Level Post Approval Change in Biological Product- Tightening of Temperature Criterion of Diluent Used in GSK's Rotavirus Vaccine (Live Attenuated, Oral) IP [Rotatix]. F. / 12-64/GSK/PAC- Boostrix&Infanrix/16- BD 9-Dec-16 DCGI Diary Dec GlaxoSmithKline 56 GlaxoSmithKline Application for Approval of a Level Post Approval Change in Biological Products - Revision of Glass Vial Container Release Specifications for all Vaccine Formulations Filled in Glass Vial Containers. 1. Inactivated Hepatitis A Vaccine (Adsorbed) IP [Havrix 1440 (Adult)/720 (Junior)] 2. Poliomyelitis Vaccine (Inactivated) IP [Poliorix] 3. Measles, Mumps, Rubella and Varicella Vaccine (Live) Ph. Eur. [Priorix-Tetra] 4. Pneumococcal Polysaccharide Conjugate Vaccine (Adosrbed) Ph. Eur. [Synflorix] 5. Varicella Vaccine, Live IP [Varilrix] tification of Post Approval Change (Level ) in Biological Product Use of a new working seed of Streptococcus pneumoniae serotype 18C used to produce PS18C bulks, an intermediate in the production of GSK s pneumococcal vaccine (SYNFLORIX) F /GSK/PAC- Many vaccines/16-bd 21-Dec-16 DCGI Diary Dec-16

17 57 GlaxoSmithKline 58 GlaxoSmithKline Asia Private Application for Post-Approval Change (Level ) in Biological Product Extension of shelf-life for GSK s pneumococcal polysaccharide conjugate vaccine [SYNFLORIX] in 1-dose and 2- dose Vial from 36 to 48months Application for Approval of a Level Post Approval Change in Biological Products - Revision of Glass Vial Container Release Specifications for all Vaccine Formulations Filled in Glass Vial Containers. 1. Human Papillomavirus Vaccine rdna Ph. Eur. [Cervarix] 2. Measles, Mumps and Rubella Vaccine (Live) [Priorix] 3. Rotavirus Vaccine (Live Attenuated,-Oral) LP. [Rotarix] F / GSK/PAC- Synflorix/ 16-BD 28-Dec-16 F /GSK/PAC- Many vac/16-bd 9-Jan-17