Nitrendipin Beta 10
alt informationenCommon Technical Document Module 3 (Quality) Index of Change_
|
Applicant: |
Active drug substance: |
|
betapharm Arzneimittel GmbH |
Nitrendipin |
|
Product: |
Strength: |
|
Nitrendipin 10 / 20 mg tablets |
10 and 20 mg |
Index of Change
Date of Submission: 23/02/2011
Nothing other than what is mentioned below has been changed in the overall content. Unless otherwise stated, changes apply to all strengths.
|
ctd-section |
Topic |
Present (07/2009) |
Proposed (02/2011) |
Reason for Change |
|
1.3.1 |
PIL |
Hersteller |
Hersteller: |
SKNR: 1002 |
|
Bayer HealthCare Manufacturing S.r.l., Via delle |
Bayer HealthCare Manufacturing S.r.l., Viale Certosa, | |||
|
Groane, 126 |
130, | |||
|
I-20024 Garbagnate Milanese |
I-20156 Milano | |||
|
3.2.P.3.1 |
Manufacturer(s) |
Manufacture of bulk product |
Manufacture of bulk product |
Change of the |
|
Bayer HealthCare Manufacturing S.r.l. |
Bayer HealthCare Manufacturing S.r.l. |
address of the batch | ||
|
Via delle Groane, 126 |
Via delle Groane, 126 |
release site | ||
|
20024 Garbagnate Milanese |
20024 Garbagnate Milanese | |||
|
Italy |
Italy |
SKNR: 1448 | ||
|
Packaging site (Primary and Secondary) |
Packaging site (Primary and Secondary) | |||
|
Bayer HealthCare Manufacturing S.r.l. |
Bayer HealthCare Manufacturing S.r.l. | |||
|
Via delle Groane, 126 |
Via delle Groane, 126 | |||
|
20024 Garbagnate Milanese |
20024 Garbagnate Milanese | |||
|
Italy |
Italy | |||
|
Alternative: |
Alternative: | |||
|
Bayer Schering Pharma AG |
Bayer Schering Pharma AG | |||
|
51368 Leverkusen |
51368 Leverkusen | |||
|
Germany |
Germany |
Common Technical Document Module 3 (Quality) Index of Change_
|
Applicant: |
Active drug substance: |
|
betapharm Arzneimittel GmbH |
Nitrendipin |
|
Product: |
Strength: |
|
Nitrendipin 10 / 20 mg tablets |
10 and 20 mg |
|
ctd-section |
Topic |
Present (07/2009) |
Proposed (02/2011) |
Reason for Change |
|
Alternative secondarv nackaeine site Pharbil Waltrop GmbH Im Wirringen 25 45731 Waltrop, Germany |
Alternative secondary nackaeine site Pharbil Waltrop GmbH Im Wirrineen 25 45731 Waltrop, Germany | |||
|
Oualitv control testine Bayer HealthCare Manufacturing S.r.l. Via delle Groane, 126 20024 Garbagnate Milanese Italy |
Ouality control testine Bayer HealthCare Manufacturine S.r.l. Via delle Groane, 126 20024 Garbaenate Milanese Italy | |||
|
Alternative: |
Alternative: | |||
|
Bayer Schering Pharma AG 51368 Leverkusen Germany |
Bayer Scherine Pharma AG 51368 Leverkusen Germany | |||
|
Stabilitv storaee and testine Bayer HealthCare Manufacturine S.r.l. Via delle Groane, 126 20024 Garbaenate Milanese Italy |
Stability storaee and testine Bayer HealthCare Manufacturine S.r.l. Via delle Groane, 126 20024 Garbaenate Milanese Italy | |||
|
Release to market Bayer HealthCare Manufacturine S.r.l. Via delle Groane, 126 20024 Garbaenate Milanese Italy |
Release to market Bayer HealthCare Manufacturine S.r.l. Viale Certosa, 130 20156 Milano Italy |
Version 03 02/2011 Module 3 2 of 2